{ "dataset": "Dental implant brands", "description": "Published implant brands with parent company, country of origin, provenance and regulatory records.", "version": "2026.07.22", "generated": "2026-07-22", "licence": "CC BY 4.0", "licenceUrl": "https://creativecommons.org/licenses/by/4.0/", "attribution": "Dental Implants Guide (https://dental-implants-guide.com)", "publisher": "IDAOPS CONSULTING LTD, company number 16927251", "claimModel": "https://dental-implants-guide.com/evidence/methodology/", "note": "Each spec is a claim object carrying its own kind, sources, confidence and verification date. A manufacturer_claim is the maker’s statement about its own product and is not independent evidence — do not report it as a verified measurement.", "count": 40, "records": [ { "id": "adin", "type": "brand", "name": "Adin", "url": "https://dental-implants-guide.com/brands/adin/", "aliases": [ "Adin Dental Implants" ], "definition": "An Israeli dental implant brand founded in 2001, offering the CloseFit, UNIFIT and zygomatic implant lines.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Adin Dental Implants Systems Ltd.", "sources": [ { "sourceId": "adin-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "adin-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "founded": { "kind": "verified_fact", "value": "2001", "sources": [ { "sourceId": "adin-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Range described by line — CloseFit, UNIFIT (internal hex) and a zygomatic implant — with a digital guided-surgery workflow (Adinguide)", "sources": [ { "sourceId": "adin-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K252031", "holder": "Adin Dental Implant Systems , Ltd.", "deviceName": "Adin Long Dental Implant System", "date": "2026-03-23", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K250178", "holder": "Adin Dental Implant Systems , Ltd.", "deviceName": "Adin Customized Abutments", "date": "2025-10-17", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K212775", "holder": "Adin Dental Implants Systems , Ltd.", "deviceName": "Adin Short Implants", "date": "2022-07-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K081751", "holder": "Adin Dental Implants System, Ltd.", "deviceName": "ADIN DENTAL IMPLANTS SYSTEM", "date": "2008-12-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3007518363", "holder": "ADIN DENTAL IMPLANT SYSTEMS LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "180 device records", "holder": "Adin", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (71); MR Conditional (29). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "adin-about", "title": "About Adin — Adin Dental Implant Systems", "publisher": "Adin Dental Implants Systems Ltd.", "url": "https://www.adin-implants.com/about-us/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "anthogyr", "type": "brand", "name": "Anthogyr", "url": "https://dental-implants-guide.com/brands/anthogyr/", "aliases": [ "Anthogyr SAS", "Axiom" ], "definition": "A French implant brand based in Sallanches, wholly owned by the Straumann Group, whose main implant range is Axiom.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Straumann Group", "sources": [ { "sourceId": "straumann-annual-report-2025" }, { "sourceId": "anthogyr-straumann-2019" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Straumann Holding AG", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "France", "sources": [ { "sourceId": "anthogyr-straumann-2019" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Sallanches, France", "sources": [ { "sourceId": "anthogyr-straumann-2019" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "The company began manufacturing dental implants in 1980", "sources": [ { "sourceId": "anthogyr-straumann-2019" } ], "confidence": "high", "verifiedAt": "2026-07-21", "note": "The wider Anthogyr business is older; we have not confirmed its original founding date from a primary source" }, "ownership": { "kind": "verified_fact", "value": "Anthogyr SAS is listed at 100% ownership in the Straumann Group’s statutory group-companies table. Straumann took an initial 30% stake in early 2016 and completed full ownership in 2019", "sources": [ { "sourceId": "straumann-annual-report-2025" }, { "sourceId": "anthogyr-straumann-2019" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Product families centre on the Axiom implant platform, with bone-level, tissue-level and multi-unit prosthetic options", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "France", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K231072", "holder": "Anthogyr", "deviceName": "Anthogyr FlexiBase® titanium bases for Axiom® BL", "date": "2024-01-04", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230104", "holder": "Anthogyr", "deviceName": "Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL", "date": "2023-10-16", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K161177", "holder": "Anthogyr Sas", "deviceName": "Axiom PX", "date": "2017-06-15", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K141450", "holder": "Anthogyr Sas", "deviceName": "AXIOM 2.8", "date": "2014-09-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K131066", "holder": "Anthogyr Sas", "deviceName": "AXIOM REG", "date": "2014-02-21", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K101913", "holder": "Anthogyr Sas", "deviceName": "ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM", "date": "2011-03-11", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "8020776", "holder": "ANTHOGYR", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in France. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "77 device records", "holder": "Anthogyr", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 77 records we inspected, 77 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (77). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "straumann-annual-report-2025", "title": "Straumann Group Annual Report 2025", "publisher": "Straumann Holding AG", "url": "https://www.straumann.com/content/dam/media-center/group/en/documents/annual-report/2025/Straumann_AR25.pdf", "tier": "manufacturer_primary", "sourceType": "Audited annual report, including the statutory list of group companies", "publishedDate": "2026", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "anthogyr-straumann-2019", "title": "Anthogyr joins the Straumann Group", "publisher": "Anthogyr SAS (distributed via GlobeNewswire)", "url": "https://www.globenewswire.com/news-release/2019/03/12/1751726/0/en/Anthogyr-joins-the-Straumann-Group.html", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2019-03-12", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "astra-tech", "type": "brand", "name": "Astra Tech Implant System", "url": "https://dental-implants-guide.com/brands/astra-tech/", "aliases": [ "Astra Tech", "Astra Tech Implant System EV", "Astra Tech Implant System TX" ], "definition": "The implant brand of Swedish origin now owned by Dentsply Sirona, sold today mainly as the Astra Tech Implant System EV.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "DENTSPLY SIRONA Inc.", "sources": [ { "sourceId": "dentsply-sirona-brand-index" }, { "sourceId": "dentsply-sirona-implant-systems" }, { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "DENTSPLY SIRONA Inc., Charlotte, North Carolina", "sources": [ { "sourceId": "dentsply-sirona-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "status": { "kind": "verified_fact", "value": "Current — listed among Dentsply Sirona’s implant systems, in both EV and TX generations", "sources": [ { "sourceId": "dentsply-sirona-brand-index" }, { "sourceId": "dentsply-sirona-implant-systems" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "unknown", "reason": "manufacturer_documentation_not_located", "note": "Astra Tech originated in Sweden; we have not confirmed a founding date for the implant business from a primary source" }, "positioning": { "kind": "manufacturer_claim", "value": "The EV implant family is presented as three implant body designs — Astra Tech Implant EV, PrimeTaper EV and OmniTaper EV — sharing a single prosthetic connection, using a site-specific, crown-down approach", "sources": [ { "sourceId": "dentsply-sirona-implant-systems" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K111287", "holder": "Astra Tech AB", "deviceName": "ASTRA TECH IMPLANT SYSTEM", "date": "2011-09-26", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K101732", "holder": "Astra Tech AB", "deviceName": "ASTRA TECH IMPLANT SYSTEM", "date": "2011-02-23", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K091239", "holder": "Astra Tech AB", "deviceName": "ASTRA TECH IMPLANT SYSTEM", "date": "2009-09-22", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K053384", "holder": "Astra Tech, Inc.", "deviceName": "FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM", "date": "2006-03-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K041492", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS - DENTAL SYSTEM", "date": "2004-08-09", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K024111", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS-DENTAL SYSTEM FIXTURE OSSEOSPEED", "date": "2003-06-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K002513", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS - DENTAL SYSTEM", "date": "2001-01-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K990304", "holder": "Astra Tech, Inc.", "deviceName": "MODIFICATION TO ASTRA TECH IMPLANT - DENTAL SYSTEM", "date": "1999-07-15", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K991053", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)", "date": "1999-06-25", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K974738", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANT DENTAL SYSTEM", "date": "1998-11-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K974737", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANT DENTAL SYSTEM", "date": "1998-03-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K980698", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS - DENTAL SYSTEM", "date": "1998-03-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K931767", "holder": "Astra Tech, Inc.", "deviceName": "ASTRA TECH IMPLANTS-DENTAL SYSTEM", "date": "1994-02-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "dentsply-sirona-brand-index", "title": "Shop dental products by brand — Dentsply Sirona", "publisher": "DENTSPLY SIRONA Inc.", "url": "https://www.dentsplysirona.com/en-us/shop/brands.html", "tier": "manufacturer_primary", "sourceType": "Manufacturer brand index", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentsply-sirona-implant-systems", "title": "Dental Implant Systems — Dentsply Sirona USA", "publisher": "DENTSPLY SIRONA Inc.", "url": "https://www.dentsplysirona.com/en-us/discover/discover-by-category/implant-dentistry/implant-systems.html", "tier": "manufacturer_primary", "sourceType": "Manufacturer product-category page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentsply-sirona-mis-acquisition-2016", "title": "Dentsply Sirona acquires MIS Implants", "publisher": "DENTSPLY SIRONA Inc.", "url": "https://www.dentsplysirona.com/content/dam/dentsply-sirona/news-assets/article-assets/2016-06-27-dentsply-sirona-acquires-mis-implants/Dentsply%20Sirona_PR_MIS%20Acquisition-2016-06-27.pdf", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2016-06-27", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentsply-sirona-10k-2025", "title": "DENTSPLY SIRONA Inc. — Annual Report on Form 10-K for the year ended 31 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/818479/000081847926000075/xray-20251231.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-26", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "bego-semados", "type": "brand", "name": "BEGO Semados", "url": "https://dental-implants-guide.com/brands/bego-semados/", "aliases": [ "BEGO", "Semados", "BEGO Implant Systems" ], "definition": "The implant brand of the German manufacturer BEGO, covering the Semados RS, RSX, SC, SCX, RI and S implant lines.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "BEGO GmbH & Co. KG, through BEGO Implant Systems", "sources": [ { "sourceId": "bego-implantology" }, { "sourceId": "bego-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "BEGO GmbH & Co. KG, Bremen", "sources": [ { "sourceId": "bego-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Germany", "sources": [ { "sourceId": "bego-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Bremen, Germany", "sources": [ { "sourceId": "bego-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "unknown", "reason": "manufacturer_documentation_not_located", "note": "BEGO itself dates from 1890; we have not confirmed when the Semados implant line was introduced" }, "ownership": { "kind": "manufacturer_claim", "value": "Part of the family-owned BEGO group", "sources": [ { "sourceId": "bego-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "prosthetics": { "kind": "manufacturer_claim", "value": "Implant lines named by the manufacturer include Semados RS and RSX, SC and SCX, RI and S, with guided surgery and naturesQue regeneration materials alongside", "sources": [ { "sourceId": "bego-implantology" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Germany", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K201700", "holder": "Bego Implant Systems GmbH & Co. KG", "deviceName": "BEGO Semados® RS/RSX Implant System", "date": "2021-01-13", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K090716", "holder": "Bego Implant Systems GmbH & Co. KG", "deviceName": "BEGO SEMADOS S-LINE", "date": "2009-10-06", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3008252251", "holder": "BEGO IMPLANT SYSTEMS GMBH & CO. KG", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Germany. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "bego-implantology", "title": "Implantology solutions — BEGO", "publisher": "BEGO GmbH & Co. KG", "url": "https://www.bego.com/implantology/", "tier": "manufacturer_primary", "sourceType": "Manufacturer product-category page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "bego-company", "title": "Company — BEGO", "publisher": "BEGO GmbH & Co. KG", "url": "https://www.bego.com/company/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "bicon", "type": "brand", "name": "Bicon", "url": "https://dental-implants-guide.com/brands/bicon/", "aliases": [ "Bicon Dental Implants", "Bicon SHORT" ], "definition": "The Boston-based implant brand known for short plateaued implants and a locking-taper implant-to-abutment connection with no abutment screw.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Bicon Dental Implants", "sources": [ { "sourceId": "bicon-patient-information" }, { "sourceId": "bicon-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Bicon Dental Implants, Boston", "sources": [ { "sourceId": "bicon-patient-information" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "bicon-patient-information" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "501 Arborway, Boston, Massachusetts, United States", "sources": [ { "sourceId": "bicon-patient-information" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "The Bicon implant system was introduced in 1985; the design lineage runs back to research begun in 1968 at the Battelle Memorial Institute", "sources": [ { "sourceId": "bicon-history" }, { "sourceId": "bicon-patient-information" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "manufacturer_claim", "value": "A locking-taper implant-to-abutment connection, described by the manufacturer as providing 360 degrees of abutment positioning", "sources": [ { "sourceId": "bicon-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "shortImplant": { "kind": "manufacturer_claim", "value": "The manufacturer states that the 1985 system included 8.0 mm implants, considered very short at the time, with shorter designs introduced subsequently", "sources": [ { "sourceId": "bicon-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K101849", "holder": "Bicon, LLC", "deviceName": "BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT", "date": "2010-10-01", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K092035", "holder": "Bicon, LLC", "deviceName": "BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTION", "date": "2009-10-15", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K050408", "holder": "Bicon, Inc.", "deviceName": "BICON ORTHODONTIC IMPLANT SYSTEM", "date": "2005-04-07", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K023705", "holder": "Bicon, Inc.", "deviceName": "BICON TRANSITIONAL IMPLANT (BTI) SYSTEM", "date": "2003-01-29", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K994037", "holder": "Bicon, Inc.", "deviceName": "THE 4.5MM DIAMETER BICON DENTAL IMPLANT", "date": "2000-01-11", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K982488", "holder": "Bicon, Inc.", "deviceName": "BICON BONE SCREW SYSTEM", "date": "1999-01-26", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K972029", "holder": "Bicon, Inc.", "deviceName": "BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM", "date": "1997-08-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1223843", "holder": "BICON, LLC", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "362 device records", "holder": "Bicon", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 97 are supplied sterile, 3 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "bicon-patient-information", "title": "Bicon Dental Implants — Information for Patients", "publisher": "Bicon Dental Implants", "url": "https://www.bicon.com/patient/", "tier": "manufacturer_primary", "sourceType": "Manufacturer patient information page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "bicon-history", "title": "History of Bicon", "publisher": "Bicon Dental Implants", "url": "https://www.bicon.com/get-started-with-bicon/history-of-bicon/", "tier": "manufacturer_primary", "sourceType": "Manufacturer company-history page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "bilimplant", "type": "brand", "name": "Bilimplant", "url": "https://dental-implants-guide.com/brands/bilimplant/", "aliases": [ "Bilim İmplant" ], "definition": "A Turkish dental implant brand made by Proimtech in İstanbul, spanning narrow, bone-level, tissue-level, short and one-piece compressive implants.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Proimtech Sağlık Ürünleri A.Ş.", "sources": [ { "sourceId": "bilimplant-home" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Turkey", "sources": [ { "sourceId": "bilimplant-home" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Range described as covering Ø2.9 mm narrow implants, bone-level, tissue-level, short and one-piece compressive implants", "sources": [ { "sourceId": "bilimplant-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "founded": { "kind": "unknown", "reason": "manufacturer_documentation_not_located" } }, "certifications": [], "sources": [ { "id": "bilimplant-home", "title": "Bilimplant — Corporate site", "publisher": "Proimtech Sağlık Ürünleri A.Ş.", "url": "https://www.bilimplant.com/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate site", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implantder-members", "title": "Üyelerimiz (Members) — İMPLANTDER", "publisher": "Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER)", "url": "https://implantder.org/uyelerimiz", "tier": "professional_body", "sourceType": "Industry association membership register", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "biohorizons", "type": "brand", "name": "BioHorizons", "url": "https://dental-implants-guide.com/brands/biohorizons/", "aliases": [ "BioHorizons, Inc.", "BioHorizons Camlog" ], "definition": "A United States implant brand within Henry Schein’s Global Oral Reconstruction Group, known for its Laser-Lok surface treatment.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Henry Schein, Inc.", "sources": [ { "sourceId": "henry-schein-10k-2025" }, { "sourceId": "biohorizons-camlog-partnership" }, { "sourceId": "bhcl-brands" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Henry Schein, Inc., Melville, New York", "sources": [ { "sourceId": "henry-schein-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "biohorizons-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "unknown", "reason": "manufacturer_documentation_not_located", "note": "BioHorizons states that it manufactures in the United States; we have not confirmed a specific address from a primary source" }, "founded": { "kind": "verified_fact", "value": "1994, out of research at the University of Alabama at Birmingham, by Carl E. Misch, Martha Bidez and Todd Strong", "sources": [ { "sourceId": "biohorizons-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Owned by Henry Schein, which acquired BioHorizons in 2014. Since 2016 BioHorizons and Camlog have been operated together under the Global Oral Reconstruction Group, adopting a joint BioHorizons Camlog identity in 2019", "sources": [ { "sourceId": "henry-schein-10k-2025" }, { "sourceId": "biohorizons-camlog-partnership" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "manufacturer_claim", "value": "Laser-Lok, a laser-produced microchannel surface treatment applied to the implant collar", "sources": [ { "sourceId": "biohorizons-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "availability": { "kind": "manufacturer_claim", "value": "Manufactured in the United States and sold in more than 90 countries", "sources": [ { "sourceId": "biohorizons-history" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K223697", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "MRI compatibility for existing BioHorizons dental implants and abutments", "date": "2023-10-13", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K182070", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BioHorizons Tapered IM Implants", "date": "2018-10-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K172576", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BioHorizons Tapered Short Implants", "date": "2017-11-22", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K143022", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BioHorizons Tapered Internal Implants", "date": "2015-01-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K121787", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS", "date": "2012-09-05", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K093321", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM", "date": "2010-04-02", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K073282", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS SINGLE-STAGE IMPLANT SYSTEM", "date": "2008-02-15", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K073268", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS INTERNAL IMPLANT SYSTEM", "date": "2008-02-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K071638", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM", "date": "2007-10-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K053152", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS SINGLE-STAGE IMPLANT", "date": "2005-12-02", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K964330", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)", "date": "1997-01-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K960026", "holder": "BioHorizons Implant Systems, Inc.", "deviceName": "BIOHORIZONS DENTAL IMPLANT SYSTEM", "date": "1996-03-28", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "351 device records", "holder": "BioHorizons", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (81); Labeling does not contain MRI Safety Information (19). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "henry-schein-10k-2025", "title": "Henry Schein, Inc. — Annual Report on Form 10-K for the year ended 27 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/1000228/000100022826000013/hsic-20251227.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-24", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "biohorizons-camlog-partnership", "title": "Premium Dental Implant Systems from BioHorizons and Camlog", "publisher": "BioHorizons, Inc.", "url": "https://www.biohorizons.com/home/BioHorizonsCamlog", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "bhcl-brands", "title": "Brands of BioHorizons Camlog Group", "publisher": "BioHorizons Camlog Group", "url": "https://www.bhclgroup.com/en/brands", "tier": "manufacturer_primary", "sourceType": "Corporate brand index", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "biohorizons-history", "title": "A History of Innovating Dental Implant Solutions — BioHorizons", "publisher": "BioHorizons, Inc.", "url": "https://www.biohorizons.com/company/history", "tier": "manufacturer_primary", "sourceType": "Manufacturer company-history page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "blb", "type": "brand", "name": "BLB", "url": "https://dental-implants-guide.com/brands/blb/", "aliases": [ "Beijing Leiden Biomaterial", "BLBIII" ], "definition": "A Chinese implant brand from Beijing Leiden Biomaterial, studied in peer-reviewed work for its surface treatment.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Beijing Leiden Biomaterial (BLB)", "sources": [ { "sourceId": "yin-2012-blb-coir" } ], "confidence": "medium", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "China", "sources": [ { "sourceId": "yin-2012-blb-coir" } ], "confidence": "medium", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "Later-generation BLB implants (BLBIII) used a micro-arc oxidation (MAO) plus electrophoretic-deposition (EPD) surface producing a porous calcium/phosphorus layer, per peer-reviewed animal work; earlier BLBI used a plasma-sprayed hydroxyapatite coating", "sources": [ { "sourceId": "yin-2012-blb-coir" } ], "confidence": "medium", "verifiedAt": "2026-07-21" }, "diameters": { "kind": "unknown", "reason": "manufacturer_documentation_not_located" }, "lengths": { "kind": "unknown", "reason": "manufacturer_documentation_not_located" } }, "certifications": [], "sources": [ { "id": "yin-2012-blb-coir", "title": "The experimental research on two-generation BLB dental implants — part I: surface modification and osseointegration", "publisher": "Clinical Oral Implants Research", "url": "https://pubmed.ncbi.nlm.nih.gov/21564304/", "tier": "peer_reviewed", "sourceType": "Peer-reviewed animal study", "publishedDate": "2012", "accessedDate": "2026-07-21", "verificationStatus": "reachable" } ] }, { "id": "bredent-sky", "type": "brand", "name": "bredent SKY", "url": "https://dental-implants-guide.com/brands/bredent-sky/", "aliases": [ "SKY", "blueSKY", "SKY Implant System" ], "definition": "The SKY dental implant system from Germany’s bredent medical, built on a tube-in-tube connection and marketed since 2002.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "bredent medical GmbH & Co. KG", "sources": [ { "sourceId": "bredent-innovations" }, { "sourceId": "bredent-sky-system" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Germany", "sources": [ { "sourceId": "bredent-innovations" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "connection": { "kind": "manufacturer_claim", "value": "Tube-in-tube connection", "sources": [ { "sourceId": "bredent-sky-system" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Family of implants — narrowSKY, blueSKY, classicSKY, copaSKY, whiteSKY (ceramic) and mini SKY — marketed for immediate restoration", "sources": [ { "sourceId": "bredent-sky-system" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "bredent-innovations", "title": "bredent — Dental Innovations since 1974", "publisher": "bredent group GmbH & Co. KG", "url": "https://www.bredent-implants.com/bredent-dental-innovations/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "bredent-sky-system", "title": "SKY Implant System", "publisher": "bredent medical GmbH & Co. KG", "url": "https://www.bredent-implants.com/products-solutions/sky-implant-system/", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "camlog", "type": "brand", "name": "CAMLOG", "url": "https://dental-implants-guide.com/brands/camlog/", "aliases": [ "Camlog", "CAMLOG Biotechnologies GmbH", "CONELOG" ], "definition": "A Swiss-headquartered implant brand within Henry Schein’s oral reconstruction division, offering the CAMLOG, CONELOG, CERALOG and iSy systems.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Henry Schein, Inc.", "sources": [ { "sourceId": "camlog-company" }, { "sourceId": "henry-schein-10k-2025" }, { "sourceId": "bhcl-brands" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Henry Schein, Inc., Melville, New York", "sources": [ { "sourceId": "henry-schein-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Switzerland, with manufacturing in Germany", "sources": [ { "sourceId": "camlog-worldwide" }, { "sourceId": "camlog-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "CAMLOG Biotechnologies GmbH, Grosspeteranlage 29, 4052 Basel, Switzerland", "sources": [ { "sourceId": "camlog-worldwide" }, { "sourceId": "camlog-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "unknown", "reason": "manufacturer_documentation_not_located", "note": "No founding year is stated on the company pages we were able to reach" }, "ownership": { "kind": "verified_fact", "value": "Operates under a Henry Schein division that Camlog names the Global Dental Surgical Group and Henry Schein names the Global Oral Reconstruction Group; it has worked with BioHorizons since 2016 as BioHorizons Camlog", "sources": [ { "sourceId": "camlog-company" }, { "sourceId": "bhcl-about-us" }, { "sourceId": "henry-schein-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21", "note": "The two divisional names appear to describe the same organisation; we have recorded both rather than choose between them" }, "prosthetics": { "kind": "manufacturer_claim", "value": "Product lines are CAMLOG with the Tube-in-Tube connection, CONELOG with a conical connection and platform switching, the CERALOG zirconia line and the reduced-component iSy system", "sources": [ { "sourceId": "camlog-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "availability": { "kind": "manufacturer_claim", "value": "Distributed in more than 90 countries; implants are manufactured at ALTATEC GmbH in Wimsheim, Germany", "sources": [ { "sourceId": "camlog-company" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "other", "number": "3007283751", "holder": "CAMLOG Biotechnologies GmbH", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Switzerland. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "camlog-company", "title": "Company — CAMLOG", "publisher": "CAMLOG Biotechnologies GmbH", "url": "https://www.camlog.com/en/company", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "henry-schein-10k-2025", "title": "Henry Schein, Inc. — Annual Report on Form 10-K for the year ended 27 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/1000228/000100022826000013/hsic-20251227.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-24", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "bhcl-brands", "title": "Brands of BioHorizons Camlog Group", "publisher": "BioHorizons Camlog Group", "url": "https://www.bhclgroup.com/en/brands", "tier": "manufacturer_primary", "sourceType": "Corporate brand index", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "camlog-worldwide", "title": "Camlog worldwide — international distribution", "publisher": "CAMLOG Biotechnologies GmbH", "url": "https://www.camlog.com/en/company/camlog-worldwide", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page carrying the registered address", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "bhcl-about-us", "title": "About us — BioHorizons Camlog Group", "publisher": "BioHorizons Camlog Group", "url": "https://www.bhclgroup.com/en/about-us", "tier": "manufacturer_primary", "sourceType": "Corporate website page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "cortex", "type": "brand", "name": "Cortex", "url": "https://dental-implants-guide.com/brands/cortex/", "aliases": [ "Cortex Dental" ], "definition": "The Israeli dental implant brand of Cortex Dental Implants Industries, including the MAGIX drill-less implant and the SATURN line.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Cortex Dental Implants Industries Ltd.", "sources": [ { "sourceId": "cortex-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "cortex-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Range spans MAGIX (marketed as a drill-less implant), DYNAMIX, CLASSIX, SATURN and one-piece implants", "sources": [ { "sourceId": "cortex-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K181580", "holder": "Cortex Dental Implants Industries , Ltd.", "deviceName": "Cortex CAD/CAM Abutments", "date": "2019-01-29", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K163385", "holder": "Cortex Dental Implants Industries , Ltd.", "deviceName": "Cortex Dental Implant System", "date": "2017-08-29", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K090709", "holder": "Cortex Dental Implants Industries , Ltd.", "deviceName": "CORTEX DENTAL IMPLANT SYSTEM", "date": "2009-07-07", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3007842672", "holder": "CORTEX DENTAL IMPLANTS INDUSTRIES LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "cortex-about", "title": "About Us — Cortex Dental", "publisher": "Cortex Dental Implants Industries Ltd.", "url": "https://cortex-dental.com/about-us/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "cowellmedi", "type": "brand", "name": "Cowellmedi", "url": "https://dental-implants-guide.com/brands/cowellmedi/", "aliases": [ "INNO", "INNO SLA" ], "definition": "The implant brand of Cowellmedi Co., Ltd. of South Korea, covering the INNO SLA fixture line.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Cowellmedi Co., Ltd.", "sources": [ { "sourceId": "fda-k201323-cowellmedi-inno" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k201323-cowellmedi-inno" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titanium", "sources": [ { "sourceId": "fda-k132242-cowellmedi-inno-fixture" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal connection, available in hex and non-hex forms", "sources": [ { "sourceId": "fda-k201323-cowellmedi-inno" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K241127", "holder": "Cowellmedi Co., Ltd.", "deviceName": "INNO SLA Mini Plus® Implant System", "date": "2024-12-27", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K231411", "holder": "Cowellmedi Co., Ltd.", "deviceName": "INNO SLA Submerged Hybrid Ti-Base System", "date": "2023-12-20", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K231395", "holder": "Cowellmedi Co., Ltd.", "deviceName": "INNO SLA Submerged Narrow Implant System", "date": "2023-10-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K201323", "holder": "Cowellmedi Co., Ltd.", "deviceName": "INNO SLA Submerged Implant System", "date": "2022-01-25", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K132242", "holder": "Cowellmedi Co., Ltd.", "deviceName": "INNO SLA SUBMERGED IMPLANT SYSTEM", "date": "2013-12-06", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3005115116", "holder": "COWELLMEDI CO., LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "115 device records", "holder": "Cowellmedi", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 97 are supplied sterile, 3 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k201323-cowellmedi-inno", "title": "FDA 510(k) K201323 — INNO SLA Submerged Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf20/K201323.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2022-01-25", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "fda-k132242-cowellmedi-inno-fixture", "title": "FDA 510(k) K132242 — INNO SLA Submerged Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132242.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2013-12-06", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "dentis", "type": "brand", "name": "Dentis", "url": "https://dental-implants-guide.com/brands/dentis/", "aliases": [ "s-Clean", "Dentis Implant" ], "definition": "The implant brand of Dentis Co., Ltd. of South Korea, covering the s-Clean SQ-SL and OneQ-SL fixture families.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Dentis Co., Ltd.", "sources": [ { "sourceId": "fda-k240511-dentis-sqsl-fixture" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k240511-dentis-sqsl-fixture" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titanium", "sources": [ { "sourceId": "fda-k240511-dentis-sqsl-fixture" }, { "sourceId": "fda-k210132-dentis-sqsl-regular" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal hex on the SQ-SL line; the OneQ-SL is a conical (tapered) fixture", "sources": [ { "sourceId": "fda-k240511-dentis-sqsl-fixture" }, { "sourceId": "fda-k142313-dentis-oneq-sl" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K253493", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis SQ-SL AXEL Fixture", "date": "2026-03-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K241063", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean ScanHealing Abutment", "date": "2024-07-25", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K240511", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean SQ-SL Fixture", "date": "2024-05-20", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230126", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean Regular Abutment", "date": "2023-08-04", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230307", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis i-Clean System", "date": "2023-07-11", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230246", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean SQ-SL Narrow Implant System", "date": "2023-05-25", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230523", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean Link Abutment Narrow", "date": "2023-05-24", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230203", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis I-FIX Abutment", "date": "2023-05-03", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K222913", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean Link Abutment", "date": "2023-01-13", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K220440", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean Abutment Mini", "date": "2022-06-16", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210410", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean Pre-Milled Abutment Mini", "date": "2021-09-10", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210362", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean Pre-Milled Abutment", "date": "2021-08-19", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210080", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean s-Line Mini", "date": "2021-06-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210134", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis s-Clean s-Line", "date": "2021-04-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K202773", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean SQ-SL Implant System Mini", "date": "2021-03-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210132", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean SQ-SL Implant System Regular", "date": "2021-02-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K200099", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean SQ-SL Implant System Mini", "date": "2020-04-13", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K192688", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean SQ-SL Implant System Regular", "date": "2020-02-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171694", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean TiN Coating Abutments", "date": "2017-11-29", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171027", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis Dental Implant System", "date": "2017-09-06", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K170220", "holder": "Dentis Co., Ltd.", "deviceName": "OneQ-SL s-Clean Implant System", "date": "2017-04-27", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K161244", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean OneQ-SL Narrow Implant System", "date": "2016-12-07", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K160213", "holder": "Dentis Co., Ltd.", "deviceName": "s-Clean Tapered II RBM Implant System", "date": "2016-06-21", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K153639", "holder": "Dentis Co., Ltd.", "deviceName": "OneQ-SL s-Clean Implant System", "date": "2016-04-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K150344", "holder": "Dentis Co., Ltd.", "deviceName": "Dentis Dental Implant System", "date": "2015-07-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K082843", "holder": "Dentis Co., Ltd.", "deviceName": "MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM", "date": "2009-06-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K073486", "holder": "Dentis Co., Ltd.", "deviceName": "DENTIS DENTAL IMPLANT SYSTEM", "date": "2008-04-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1279 device records", "holder": "Dentis", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 100 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k240511-dentis-sqsl-fixture", "title": "FDA 510(k) K240511 — Dentis s-Clean SQ-SL Fixture", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf24/K240511.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2024-05-20", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "fda-k210132-dentis-sqsl-regular", "title": "FDA 510(k) K210132 — s-Clean SQ-SL Implant System Regular", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210132.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2021-02-17", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "fda-k142313-dentis-oneq-sl", "title": "FDA 510(k) K142313 — OneQ-SL Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K142313.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2015-12-10", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "dentium", "type": "brand", "name": "Dentium", "url": "https://dental-implants-guide.com/brands/dentium/", "aliases": [ "Implantium", "SuperLine" ], "definition": "The implant brand of the Korean manufacturer Dentium, covering the SuperLine, Implantium and NR Line systems.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Dentium Co., Ltd.", "sources": [ { "sourceId": "dentium-usa-about" }, { "sourceId": "dentium-krx-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Dentium Co., Ltd., listed on the Korea Exchange under code 145720", "sources": [ { "sourceId": "dentium-krx-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "dentium-krx-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Seoul, South Korea", "sources": [ { "sourceId": "dentium-krx-profile" }, { "sourceId": "dentium-usa-about" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "June 2000, as Biostech Co., Ltd.; renamed Dentium in August 2002", "sources": [ { "sourceId": "dentium-usa-about" }, { "sourceId": "dentium-krx-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "prosthetics": { "kind": "manufacturer_claim", "value": "Implant systems named by the manufacturer include SuperLine, SuperLine II, Implantium and NR Line", "sources": [ { "sourceId": "dentium-usa-about" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "availability": { "kind": "manufacturer_claim", "value": "Sold in more than 80 countries", "sources": [ { "sourceId": "dentium-usa-about" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K213599", "holder": "Dentium Co., Ltd.", "deviceName": "SuperLine", "date": "2022-02-23", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K172640", "holder": "Dentium Co., Ltd.", "deviceName": "Dentium Implantium & SuperLine Prosthetics", "date": "2018-05-14", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171622", "holder": "Dentium Co., Ltd.", "deviceName": "Dentium Ti-Base", "date": "2018-01-11", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171126", "holder": "Dentium Co., Ltd.", "deviceName": "Implantium II", "date": "2017-09-07", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K170384", "holder": "Dentium Co., Ltd.", "deviceName": "Dentium NR Line CAD/CAM Abutments", "date": "2017-08-17", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K160965", "holder": "Dentium Co., Ltd.", "deviceName": "SuperLine", "date": "2017-01-13", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K161713", "holder": "Dentium Co., Ltd.", "deviceName": "Dentium CAD/CAM Abutments", "date": "2016-12-16", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K160828", "holder": "Dentium Co., Ltd.", "deviceName": "Dentium Implantium & SuperLine Prosthetics", "date": "2016-09-15", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K141457", "holder": "Dentium Co., Ltd.", "deviceName": "DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS", "date": "2014-11-12", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K060501", "holder": "Dentium Co., Ltd.", "deviceName": "IMPLANTIUM II", "date": "2006-06-16", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K041368", "holder": "Dentium Co., Ltd.", "deviceName": "DENTIUM CO., LTD. IMPLANTIUM", "date": "2004-07-29", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "408 device records", "holder": "Dentium", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 82 are supplied sterile, 18 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "dentium-usa-about", "title": "About Dentium USA", "publisher": "DentiumUSA", "url": "https://www.dentiumusa.com/about-dentium", "tier": "manufacturer_primary", "sourceType": "Manufacturer subsidiary corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentium-krx-profile", "title": "Dentium Co., Ltd. (KRX: 145720) company profile", "publisher": "StockAnalysis", "url": "https://stockanalysis.com/quote/krx/145720/company/", "tier": "trade_publication", "sourceType": "Listed-company reference profile", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "dio", "type": "brand", "name": "DIO", "url": "https://dental-implants-guide.com/brands/dio/", "aliases": [ "DIO Implant", "UF", "UV Active", "DIOnavi" ], "definition": "The implant brand of DIO Corporation of South Korea, covering the UF(II) and UV Active fixtures and the DIOnavi guided workflow.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "DIO Corporation", "sources": [ { "sourceId": "fda-k170608-dio-uf2" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k170608-dio-uf2" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titanium", "sources": [ { "sourceId": "fda-k170608-dio-uf2" }, { "sourceId": "fda-k182194-dio-uv-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal connection with a Morse taper", "sources": [ { "sourceId": "fda-k182194-dio-uv-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K182194", "holder": "Dio Corporation", "deviceName": "UV Active Implant System", "date": "2018-12-14", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K070570", "holder": "Dio Department Dsi, Inc.", "deviceName": "DIO IMPLANT SYSTEM", "date": "2008-04-15", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3007126709", "holder": "DIO Corporation", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k170608-dio-uf2", "title": "FDA 510(k) K170608 — UF(II) Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K170608.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2018-03-30", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "fda-k182194-dio-uv-active", "title": "FDA 510(k) K182194 — UV Active Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182194.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2018-12-14", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "dti", "type": "brand", "name": "DTI", "url": "https://dental-implants-guide.com/brands/dti/", "aliases": [ "DTI Implant Systems", "DTİ İmplant" ], "definition": "The dental implant brand of İstanbul-based DTİ İmplant Sistemleri, developed with support from the Turkish research council TÜBİTAK.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "DTİ İmplant Sistemleri San. Tic. A.Ş.", "sources": [ { "sourceId": "dti-about" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Turkey", "sources": [ { "sourceId": "dti-about" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as a Turkish-developed implant system produced with TÜBİTAK and Council of Europe Development Bank support", "sources": [ { "sourceId": "dti-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "dti-about", "title": "Hakkımızda — DTİ İmplant Sistemleri", "publisher": "DTİ İmplant Sistemleri San. Tic. A.Ş.", "url": "https://dtiimplant.com.tr/hakkimizda/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implantder-members", "title": "Üyelerimiz (Members) — İMPLANTDER", "publisher": "Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER)", "url": "https://implantder.org/uyelerimiz", "tier": "professional_body", "sourceType": "Industry association membership register", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "global-d", "type": "brand", "name": "Global D", "url": "https://dental-implants-guide.com/brands/global-d/", "aliases": [ "GlobalD" ], "definition": "The French dental implant brand of Global D, whose ranges include In-Kone, twinKon and EVL.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Global D SASU", "sources": [ { "sourceId": "globald-legal" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "France", "sources": [ { "sourceId": "globald-legal" }, { "sourceId": "globald-twinkon" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Implant ranges include In-Kone, twinKon and EVL", "sources": [ { "sourceId": "globald-twinkon" } ], "confidence": "medium", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "globald-legal", "title": "Legal Notices — Global D", "publisher": "Global D SASU", "url": "https://www.globald.com/en/legal-notices/", "tier": "manufacturer_primary", "sourceType": "Manufacturer legal/corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "globald-twinkon", "title": "twinKon Implant System — Global D", "publisher": "Global D SASU", "url": "https://www.globald.com/en/implantology/implants-prosthetics/twinkon-implant-system/", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "hiossen", "type": "brand", "name": "Hiossen", "url": "https://dental-implants-guide.com/brands/hiossen/", "aliases": [ "Hiossen Implant", "Hiossen, Inc." ], "definition": "The brand under which Osstem Implant sells its implants in the United States, established in Pennsylvania in 2006.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Osstem Implant Co., Ltd.", "sources": [ { "sourceId": "hiossen-about-us" }, { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Osstem Implant Co., Ltd., South Korea", "sources": [ { "sourceId": "hiossen-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "hiossen-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "85 Ben Fairless Drive, Fairless Hills, Pennsylvania, United States", "sources": [ { "sourceId": "hiossen-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "2006, in Pennsylvania, established by its parent company Osstem", "sources": [ { "sourceId": "hiossen-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Established by, and part of, Osstem Implant", "sources": [ { "sourceId": "hiossen-about-us" }, { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K241003", "holder": "Hiossen, Inc.", "deviceName": "HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)", "date": "2025-01-08", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K140934", "holder": "Hiossen, Inc.", "deviceName": "HIOSSEN IMPLANT SYSTEM", "date": "2014-11-12", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K140507", "holder": "Osstem Implant Co., Ltd.", "deviceName": "HIOSSEN PROSTHETIC SYSTEM", "date": "2014-08-20", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3007135442", "holder": "HIOSSEN INC.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1257 device records", "holder": "Hiossen", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (188); MR Conditional (12). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "hiossen-about-us", "title": "About Us — Hiossen Implant", "publisher": "Hiossen, Inc.", "url": "https://www.hiossen.com/about-us", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "osstem-europe-about-us", "title": "About us — Osstem Implant", "publisher": "Osstem Implant Co., Ltd.", "url": "https://osstem.at/about-us/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "idis", "type": "brand", "name": "IDIS", "url": "https://dental-implants-guide.com/brands/idis/", "aliases": [ "S-Plant" ], "definition": "The implant brand of IDIS Co., Ltd. of South Korea, whose product is the S-Plant dental implant system.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "IDIS Co., Ltd.", "sources": [ { "sourceId": "fda-k221866-idis-s-plant" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k221866-idis-s-plant" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titanium", "sources": [ { "sourceId": "fda-k221866-idis-s-plant" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Tapered conical-hex connection", "sources": [ { "sourceId": "fda-k221866-idis-s-plant" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K231429", "holder": "Idis Co., Ltd.", "deviceName": "S-Plant Dental Implant System", "date": "2023-12-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3026365523", "holder": "IDIS CO., LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k221866-idis-s-plant", "title": "FDA 510(k) K221866 — S-Plant Dental Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221866.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2023-01-01", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "implance", "type": "brand", "name": "Implance", "url": "https://dental-implants-guide.com/brands/implance/", "aliases": [ "Implance Dental Implant System" ], "definition": "The dental implant brand of Turkey’s AGS Medikal, offering bone-level, tissue-level and short implants built around an internal conical connection.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.", "sources": [ { "sourceId": "implance-hakkimizda" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Turkey", "sources": [ { "sourceId": "implance-hakkimizda" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "connection": { "kind": "manufacturer_claim", "value": "Internal 11-degree conical (Morse-taper) connection with platform switching", "sources": [ { "sourceId": "implance-design-spec" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "surface": { "kind": "manufacturer_claim", "value": "RBM — a resorbable-blasting-media roughened surface", "sources": [ { "sourceId": "implance-surface-spec" }, { "sourceId": "implance-catalog-en" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as a hybrid cylindrical/conical implant system covering bone-level, tissue-level and short indications", "sources": [ { "sourceId": "implance-catalog-en" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [ { "type": "fda_510k", "number": "K160221", "holder": "Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.", "deviceName": "Implance Dental Implant System, Implance Dental Abutment System", "date": "2016-09-12", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "implance-hakkimizda", "title": "Hakkımızda — Implance (AGS Medikal)", "publisher": "AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.", "url": "https://implance.com/hakkimizda/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implantder-members", "title": "Üyelerimiz (Members) — İMPLANTDER", "publisher": "Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER)", "url": "https://implantder.org/uyelerimiz", "tier": "professional_body", "sourceType": "Industry association membership register", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implance-design-spec", "title": "Design Specifications — Implance", "publisher": "AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.", "url": "https://implance.com/en/design-specifications/", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implance-surface-spec", "title": "Surface Specifications — Implance", "publisher": "AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.", "url": "https://implance.com/en/surface-specifications/", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implance-catalog-en", "title": "Implance Dental Implant System — Catalogue (EN)", "publisher": "AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.", "url": "https://implance.com/wp-content/themes/implancetheme/docs/en/implanceCatalogEN-0822.pdf", "tier": "manufacturer_primary", "sourceType": "Manufacturer product catalogue (PDF)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "implant-direct", "type": "brand", "name": "Implant Direct", "url": "https://dental-implants-guide.com/brands/implant-direct/", "aliases": [ "Implant Direct Sybron" ], "definition": "A United States implant brand within Envista Holdings, built on a direct-to-clinician sales model and positioned in the value segment.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Envista Holdings Corporation", "sources": [ { "sourceId": "envista-10k-2025" }, { "sourceId": "implant-direct-about-us" }, { "sourceId": "envista-specialty-products" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Envista Holdings Corporation, Brea, California", "sources": [ { "sourceId": "envista-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "implant-direct-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "3050 East Hillcrest Drive, Thousand Oaks, California, United States", "sources": [ { "sourceId": "implant-direct-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "unknown", "reason": "requires_manual_verification", "note": "The company describes nearly 20 years of activity and the launch of its ScrewPlant system, but gives no explicit founding year on the pages we reached" }, "ownership": { "kind": "verified_fact", "value": "Acquired in 2010 by Sybron Dental Specialties, then a Danaher subsidiary; the business subsequently became part of Envista Holdings", "sources": [ { "sourceId": "implant-direct-about-us" }, { "sourceId": "envista-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as offering high-quality implant solutions within the Envista portfolio, sold directly to clinicians", "sources": [ { "sourceId": "envista-specialty-products" }, { "sourceId": "implant-direct-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K222211", "holder": "Implant Direct Sybron Manufacturing, LLC", "deviceName": "Implant Direct Dental Implant Systems Portfolio - MR Conditional", "date": "2023-02-02", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "873 device records", "holder": "Implant Direct", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 156 are supplied sterile, 44 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "envista-10k-2025", "title": "Envista Holdings Corporation — Annual Report on Form 10-K for the year ended 31 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/1757073/000175707326000011/nvst-20251231.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-12", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "implant-direct-about-us", "title": "About Us — Implant Direct", "publisher": "Implant Direct", "url": "https://www.implantdirect.com/en-int/about-us", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "envista-specialty-products", "title": "Specialty Products & Technology — Envista", "publisher": "Envista Holdings Corporation", "url": "https://envistaco.com/en/specialty-products-technology", "tier": "manufacturer_primary", "sourceType": "Corporate website page listing operating companies", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "leone", "type": "brand", "name": "Leone Implant System", "url": "https://dental-implants-guide.com/brands/leone/", "aliases": [ "Leone", "Leone Exacone" ], "definition": "The Italian dental implant brand of Leone S.p.A., an orthodontic and implant manufacturer near Florence.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Leone S.p.A.", "sources": [ { "sourceId": "leone-english" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Italy", "sources": [ { "sourceId": "leone-english" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Implant range added in the early 2000s to a long-standing orthodontic business", "sources": [ { "sourceId": "leone-english" } ], "confidence": "medium", "verifiedAt": "2026-07-22" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Italy", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K070483", "holder": "Leone S.P.A.", "deviceName": "LEONE MONOIMPLANT FOR O-RING OVERDENTURE", "date": "2007-04-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K050586", "holder": "Leone S.P.A.", "deviceName": "LEONE IMPLANT SYSTEM", "date": "2006-02-27", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3001561923", "holder": "LEONE SPA", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Italy. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "404 device records", "holder": "Leone Implant System", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 31 are supplied sterile, 69 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "leone-english", "title": "Leone S.p.A. — Orthodontics and Implantology", "publisher": "Leone S.p.A.", "url": "https://www.leone.it/english/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate site", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "medentika", "type": "brand", "name": "Medentika", "url": "https://dental-implants-guide.com/brands/medentika/", "aliases": [ "Medentika GmbH" ], "definition": "A German brand within the Straumann Group supplying implant prosthetics compatible with other manufacturers’ systems, together with a range of titanium implants.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Straumann Group", "sources": [ { "sourceId": "straumann-annual-report-2025" }, { "sourceId": "straumann-medentika-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Straumann Holding AG", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Germany", "sources": [ { "sourceId": "straumann-medentika-2016" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Hügelsheim, Germany", "sources": [ { "sourceId": "straumann-medentika-2016" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "2005", "sources": [ { "sourceId": "straumann-medentika-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Medentika GmbH is listed at 100% ownership in the Straumann Group’s statutory group-companies table. Straumann took a 51% non-controlling stake around 2013, obtained a controlling interest under an agreement signed on 30 November 2016, and consolidated the company from 1 January 2017", "sources": [ { "sourceId": "straumann-medentika-2016" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as a provider of attractively priced implant prosthetics for most leading implant and CAD/CAM systems, alongside its own titanium implants and instruments", "sources": [ { "sourceId": "straumann-medentika-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Germany", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "other", "number": "3026444199", "holder": "Medentika GmbH", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Germany. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3008770646", "holder": "MEDENTIKA GMBH", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Germany. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "2 device records", "holder": "Medentika", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 4 records we inspected, 4 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (4). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "straumann-annual-report-2025", "title": "Straumann Group Annual Report 2025", "publisher": "Straumann Holding AG", "url": "https://www.straumann.com/content/dam/media-center/group/en/documents/annual-report/2025/Straumann_AR25.pdf", "tier": "manufacturer_primary", "sourceType": "Audited annual report, including the statutory list of group companies", "publishedDate": "2026", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "straumann-medentika-2016", "title": "Straumann is granted a controlling interest in Medentika", "publisher": "Straumann Holding AG", "url": "https://www.straumann.com/content/dam/data/media-release/en/2016/b1267927-2e5b-41da-94ec-d95d7ac143d0/Straumann_Medentika_EN.pdf", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2016-11-30", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "mis", "type": "brand", "name": "MIS", "url": "https://dental-implants-guide.com/brands/mis/", "aliases": [ "MIS Implants", "MIS Implants Technologies Ltd.", "Make It Simple" ], "definition": "An Israeli implant brand founded in 1995 and acquired by Dentsply Sirona in 2016, positioned in the value segment.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "DENTSPLY SIRONA Inc.", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" }, { "sourceId": "dentsply-sirona-brand-index" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "DENTSPLY SIRONA Inc., Charlotte, North Carolina", "sources": [ { "sourceId": "dentsply-sirona-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Bar Lev, northern Israel", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "1995, in Shlomi, Israel", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Acquired by Dentsply Sirona under a definitive agreement announced on 27 June 2016; MIS Implants Technologies Ltd. was privately held before the transaction", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "availability": { "kind": "verified_fact", "value": "At the time of acquisition, products were sold in more than 65 countries", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Positioned by Dentsply Sirona in the value segment of the implant market, kept as a distinct brand from the group’s premium lines", "sources": [ { "sourceId": "dentsply-sirona-mis-acquisition-2016" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "other", "number": "3004203816", "holder": "MIS Implants Technologies Ltd.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "446 device records", "holder": "MIS", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 66 are supplied sterile, 134 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (148); MR Conditional (52). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "dentsply-sirona-mis-acquisition-2016", "title": "Dentsply Sirona acquires MIS Implants", "publisher": "DENTSPLY SIRONA Inc.", "url": "https://www.dentsplysirona.com/content/dam/dentsply-sirona/news-assets/article-assets/2016-06-27-dentsply-sirona-acquires-mis-implants/Dentsply%20Sirona_PR_MIS%20Acquisition-2016-06-27.pdf", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2016-06-27", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentsply-sirona-brand-index", "title": "Shop dental products by brand — Dentsply Sirona", "publisher": "DENTSPLY SIRONA Inc.", "url": "https://www.dentsplysirona.com/en-us/shop/brands.html", "tier": "manufacturer_primary", "sourceType": "Manufacturer brand index", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "dentsply-sirona-10k-2025", "title": "DENTSPLY SIRONA Inc. — Annual Report on Form 10-K for the year ended 31 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/818479/000081847926000075/xray-20251231.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-26", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "mode-implant", "type": "brand", "name": "Mode Implant", "url": "https://dental-implants-guide.com/brands/mode-implant/", "aliases": [ "Mode Medikal", "ImplantKA" ], "definition": "A Turkish dental implant brand produced by Mode Medikal.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Mode Medikal San. ve Tic. Ltd. Şti.", "sources": [ { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Turkey", "sources": [ { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "founded": { "kind": "unknown", "reason": "manufacturer_documentation_not_located" } }, "certifications": [], "sources": [ { "id": "implantder-members", "title": "Üyelerimiz (Members) — İMPLANTDER", "publisher": "Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER)", "url": "https://implantder.org/uyelerimiz", "tier": "professional_body", "sourceType": "Industry association membership register", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "neobiotech", "type": "brand", "name": "Neobiotech", "url": "https://dental-implants-guide.com/brands/neobiotech/", "aliases": [ "Neo Biotech", "CMI", "IS-III" ], "definition": "The implant brand of Neobiotech Co., Ltd. of South Korea, covering the CMI IS-II and IS-III fixture families.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Neobiotech Co., Ltd.", "sources": [ { "sourceId": "fda-k181138-neobiotech-is-iii-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k181138-neobiotech-is-iii-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titanium", "sources": [ { "sourceId": "fda-k181138-neobiotech-is-iii-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal hex", "sources": [ { "sourceId": "fda-k181138-neobiotech-is-iii-active" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K232049", "holder": "Neobiotech Co., Ltd.", "deviceName": "IS-III active Short Implant", "date": "2024-03-28", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K190849", "holder": "Neobiotech Co., Ltd.", "deviceName": "IS-III active System_S-narrow Type", "date": "2019-08-14", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K181138", "holder": "Neobiotech Co., Ltd.", "deviceName": "IS-III active System", "date": "2018-10-03", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K173938", "holder": "Neobiotech Co., Ltd.", "deviceName": "IS-III HActive Fixture", "date": "2018-05-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3004730368", "holder": "NEOBIOTECH CO., LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "483 device records", "holder": "Neobiotech", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 99 are supplied sterile, 1 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (100). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k181138-neobiotech-is-iii-active", "title": "FDA 510(k) K181138 — IS-III active System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181138.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2018-10-03", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "neodent", "type": "brand", "name": "Neodent", "url": "https://dental-implants-guide.com/brands/neodent/", "aliases": [ "Neodent Grand Morse" ], "definition": "The Brazilian implant brand wholly owned by the Straumann Group and positioned as its largest global challenger, or value, brand.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Straumann Group", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Straumann Holding AG", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Brazil", "sources": [ { "sourceId": "neodent-straumann-full-ownership-2015" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Curitiba, Brazil, where the Straumann Group also operates an implant and prosthetics manufacturing site", "sources": [ { "sourceId": "neodent-straumann-full-ownership-2015" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "unknown", "reason": "requires_manual_verification", "note": "Widely reported as 1993, but we have not confirmed this against a primary source" }, "ownership": { "kind": "verified_fact", "value": "Wholly owned by the Straumann Group. Straumann acquired an initial 49% stake in 2012 and increased it to 100% in 2015", "sources": [ { "sourceId": "neodent-straumann-full-ownership-2015" }, { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Described by the group as its largest global challenger brand, intended to widen access to implant treatment at a lower price point", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K133592", "holder": "Neodent USA, Inc.", "deviceName": "NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM", "date": "2014-08-22", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "straumann-annual-report-2025", "title": "Straumann Group Annual Report 2025", "publisher": "Straumann Holding AG", "url": "https://www.straumann.com/content/dam/media-center/group/en/documents/annual-report/2025/Straumann_AR25.pdf", "tier": "manufacturer_primary", "sourceType": "Audited annual report, including the statutory list of group companies", "publishedDate": "2026", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "neodent-straumann-full-ownership-2015", "title": "Straumann increases ownership of Neodent to 100%", "publisher": "DentistryIQ", "url": "https://www.dentistryiq.com/practice-management/industry/article/16350545/straumann-increases-ownership-of-neodent-to-100", "tier": "trade_publication", "sourceType": "Trade press report on a corporate transaction", "publishedDate": "2015", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "nobel-biocare", "type": "brand", "name": "Nobel Biocare", "url": "https://dental-implants-guide.com/brands/nobel-biocare/", "aliases": [ "Nobelpharma", "Nobel Biocare Services AG" ], "definition": "The implant brand descended from Per-Ingvar Brånemark’s original titanium implant work, now owned by Envista Holdings.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Envista Holdings Corporation", "sources": [ { "sourceId": "envista-10k-2025" }, { "sourceId": "envista-specialty-products" }, { "sourceId": "nobel-biocare-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Envista Holdings Corporation, Brea, California", "sources": [ { "sourceId": "envista-10k-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "nobel-biocare-our-story" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Zurich, Switzerland, with production in the United States, Sweden and Japan", "sources": [ { "sourceId": "nobel-biocare-our-story" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "Nobelpharma was founded in Gothenburg, Sweden in 1981 and renamed Nobel Biocare in 1996; the underlying work is Per-Ingvar Brånemark’s, who placed the first titanium dental implant in 1965", "sources": [ { "sourceId": "nobel-biocare-our-story" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Owned by Envista Holdings. Danaher Corporation completed its acquisition of Nobel Biocare Holding AG on 11 December 2014, taking about 97% of the shares and moving to delist the company from the SIX Swiss Exchange; Envista was formed inside Danaher in 2018 and separated in 2019, taking Nobel Biocare with it", "sources": [ { "sourceId": "danaher-nobel-biocare-completion-2014" }, { "sourceId": "envista-10k-2025" }, { "sourceId": "nobel-biocare-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21", "note": "Nobel Biocare’s own timeline dates the Danaher acquisition to 2015; Danaher’s completion release is dated 11 December 2014, with the squeeze-out and delisting following in the first quarter of 2015. The two dates describe different stages of the same transaction." }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as a leading innovator of implant-based dental restorations, and as the group’s premium implant brand alongside the Implant Direct and Alpha-Bio Tec value businesses", "sources": [ { "sourceId": "nobel-biocare-about-us" }, { "sourceId": "envista-specialty-products" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Sweden, Netherlands, Switzerland, United States", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K252197", "holder": "Nobel Biocare AB", "deviceName": "Nobel Biocare S Series Implants", "date": "2026-02-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K212125", "holder": "Nobel Biocare AG", "deviceName": "Nobel Biocare Dental Implant Systems Portfolio - MR Conditional", "date": "2021-09-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K041661", "holder": "Nobel Biocare Uas, Inc.", "deviceName": "NOBEL BIOCARE ENDOSSEOUS IMPLANTS", "date": "2004-08-26", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K922805", "holder": "Nobelpharma USA, Inc.", "deviceName": "NOBELPHARMA TORQUE CONTROLLER", "date": "1993-07-22", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K910611", "holder": "Nobelpharma USA, Inc.", "deviceName": "NOBELPHARMA CERAONE ABUTMENT SYSTEM", "date": "1991-08-16", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K905436", "holder": "Nobelpharma USA, Inc.", "deviceName": "NOBELPHARMA DRILLING EQUIPMENT DEC 500", "date": "1991-03-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "9611992", "holder": "NOBEL BIOCARE AB", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Sweden. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3006540014", "holder": "NOBEL BIOCARE DISTRIBUTION CENTER BV", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Netherlands. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3008693672", "holder": "Nobel Biocare Services AG", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Switzerland. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3005031178", "holder": "NOBEL BIOCARE PROCERA, LLC", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "2027971", "holder": "NOBEL BIOCARE USA, LLC", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "9611993", "holder": "NOBEL BIOCARE AB, PRODUKTION", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Sweden. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1002 device records", "holder": "Nobel Biocare", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 95 are supplied sterile, 5 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (50); MR Conditional (50). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "envista-10k-2025", "title": "Envista Holdings Corporation — Annual Report on Form 10-K for the year ended 31 December 2025", "publisher": "U.S. Securities and Exchange Commission (EDGAR)", "url": "https://www.sec.gov/Archives/edgar/data/1757073/000175707326000011/nvst-20251231.htm", "tier": "regulator", "sourceType": "Statutory annual filing", "publishedDate": "2026-02-12", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "envista-specialty-products", "title": "Specialty Products & Technology — Envista", "publisher": "Envista Holdings Corporation", "url": "https://envistaco.com/en/specialty-products-technology", "tier": "manufacturer_primary", "sourceType": "Corporate website page listing operating companies", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "nobel-biocare-about-us", "title": "About us — Nobel Biocare", "publisher": "Nobel Biocare Services AG", "url": "https://www.nobelbiocare.com/en-us/about-us", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "nobel-biocare-our-story", "title": "Our story — Nobel Biocare", "publisher": "Nobel Biocare Services AG", "url": "https://www.nobelbiocare.com/en-us/our-story", "tier": "manufacturer_primary", "sourceType": "Manufacturer company-history page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "danaher-nobel-biocare-completion-2014", "title": "Danaher Completes Acquisition Of Nobel Biocare", "publisher": "Danaher Corporation (distributed via PR Newswire)", "url": "https://www.prnewswire.com/news-releases/danaher-completes-acquisition-of-nobel-biocare-300008334.html", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2014-12-11", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "noris-medical", "type": "brand", "name": "Noris Medical", "url": "https://dental-implants-guide.com/brands/noris-medical/", "aliases": [ "Noris" ], "definition": "An Israeli dental implant brand based in Nesher, notable for the Tuff implant and a broad zygomatic implant range.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Noris Medical Ltd.", "sources": [ { "sourceId": "noris-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "noris-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Range led by the Tuff implant, with Onyx, Cortical and an extensive zygomatic portfolio", "sources": [ { "sourceId": "noris-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Israel", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K210852", "holder": "Noris Medical , Ltd.", "deviceName": "Noris Medical Dental Implants System - Cortical", "date": "2022-06-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210356", "holder": "Noris Medical , Ltd.", "deviceName": "Noris Medical Dental Implants System", "date": "2022-02-04", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K162308", "holder": "Noris Medical , Ltd.", "deviceName": "Noris Medical MBI-2mm Dental Implant System", "date": "2017-03-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K153043", "holder": "Noris Medical , Ltd.", "deviceName": "Noris Medical MBI Dental Implant System", "date": "2016-04-11", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K151909", "holder": "Noris Medical , Ltd.", "deviceName": "Noris Medical Zygomatic Dental Implant System", "date": "2016-04-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K140440", "holder": "Noris Medical , Ltd.", "deviceName": "NORIS MEDICAL DENTAL IMPLANTS SYSTEM", "date": "2014-12-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3011390931", "holder": "NORIS MEDICAL LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Israel. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "448 device records", "holder": "Noris Medical", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "noris-home", "title": "Noris Medical — Dental Implant Solutions", "publisher": "Noris Medical Ltd.", "url": "https://norismedical.com/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate site", "accessedDate": "2026-07-22", "verificationStatus": "unreachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "nucleoss", "type": "brand", "name": "NucleOSS", "url": "https://dental-implants-guide.com/brands/nucleoss/", "aliases": [ "Nucleoss", "NucleOSS T6" ], "definition": "A Turkish dental implant brand from İzmir whose T6 family of bone-level implants uses an internal-hex connection and a sandblasted, acid-etched surface.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Şanlılar Tıbbi Cihazlar Medikal Kimya San. Tic. Ltd. Şti.", "sources": [ { "sourceId": "nucleoss-about" }, { "sourceId": "implantder-members" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Turkey", "sources": [ { "sourceId": "nucleoss-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "material": { "kind": "manufacturer_claim", "value": "ISO 5832-2 Grade 4 commercially pure titanium", "sources": [ { "sourceId": "nucleoss-t6-surgical-guide" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "surface": { "kind": "manufacturer_claim", "value": "maxicell — sandblasted and processed in acid baths, then treated to become hydrophilic", "sources": [ { "sourceId": "nucleoss-t6-surgical-guide" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "connection": { "kind": "manufacturer_claim", "value": "Internal hexagon connection common to all T6 diameters, with six-position (60-degree) indexing", "sources": [ { "sourceId": "nucleoss-t6-surgical-guide" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Presented as a bone-level system for delayed loading after about 12 weeks, with a TorQ variant for high primary stability", "sources": [ { "sourceId": "nucleoss-t6-surgical-guide" }, { "sourceId": "nucleoss-t6-torq-surgical-guide" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "nucleoss-about", "title": "About Us — NucleOSS", "publisher": "Şanlılar Tıbbi Cihazlar Medikal Kimya San. Tic. Ltd. Şti.", "url": "https://www.nucleoss.com/en/corporate/about-us/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "implantder-members", "title": "Üyelerimiz (Members) — İMPLANTDER", "publisher": "Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER)", "url": "https://implantder.org/uyelerimiz", "tier": "professional_body", "sourceType": "Industry association membership register", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "nucleoss-t6-surgical-guide", "title": "NucleOSS T6 Standard — Surgical Guide (EN)", "publisher": "Şanlılar Tıbbi Cihazlar Medikal Kimya San. Tic. Ltd. Şti.", "url": "https://api-nucleoss.web.tr/images/blog/dosya/1/NucleOSS%20-%20T6%20Standard%20Surgical%20Guide%20ENG-1293.pdf", "tier": "manufacturer_primary", "sourceType": "Manufacturer surgical guide (PDF)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "nucleoss-t6-torq-surgical-guide", "title": "NucleOSS T6 TorQ — Surgical Guide (EN)", "publisher": "Şanlılar Tıbbi Cihazlar Medikal Kimya San. Tic. Ltd. Şti.", "url": "https://api-nucleoss.web.tr/images/blog/dosya/1/NucleOSS%20-%20T6%20TorQ%20Surgical%20Guide%20ENG-1293.pdf", "tier": "manufacturer_primary", "sourceType": "Manufacturer surgical guide (PDF)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "osstem", "type": "brand", "name": "Osstem", "url": "https://dental-implants-guide.com/brands/osstem/", "aliases": [ "Osstem Implant", "Osstem TS" ], "definition": "The principal implant brand of Osstem Implant of South Korea, whose TS line is its flagship implant family.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Osstem Implant Co., Ltd.", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Osstem Implant Co., Ltd., a private company since its 2023 KOSDAQ delisting", "sources": [ { "sourceId": "osstem-europe-about-us" }, { "sourceId": "osstem-kosdaq-delisting-2023" } ], "confidence": "medium", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Seoul, South Korea, with manufacturing centred on Busan", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "1997", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "The TS implant is presented as the company’s flagship product", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "availability": { "kind": "manufacturer_claim", "value": "Sold through subsidiaries across more than 90 countries", "sources": [ { "sourceId": "osstem-europe-about-us" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K222778", "holder": "Osstem Implant Co., Ltd.", "deviceName": "Osstem Implant System", "date": "2023-09-23", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K221684", "holder": "Osstem Implant Co., Ltd.", "deviceName": "Osstem Abutment System", "date": "2022-09-08", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K182091", "holder": "Osstem Implant Co., Ltd.", "deviceName": "Osstem Abutment System", "date": "2019-07-12", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K161689", "holder": "Osstem Implant Co., Ltd.", "deviceName": "OSSTEM Implant System - Abutment", "date": "2017-05-22", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K161604", "holder": "Osstem Implant Co., Ltd.", "deviceName": "OSSTEM Implant System", "date": "2016-10-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3031886796", "holder": "OSSTEM IMPLANT CO., LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3003394081", "holder": "OSSTEM IMPLANT CO., LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "2157 device records", "holder": "Osstem", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "osstem-europe-about-us", "title": "About us — Osstem Implant", "publisher": "Osstem Implant Co., Ltd.", "url": "https://osstem.at/about-us/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "osstem-kosdaq-delisting-2023", "title": "Osstem Implant to be delisted from Kosdaq", "publisher": "The Korea Herald", "url": "https://www.koreaherald.com/view.php?ud=20230802000562", "tier": "trade_publication", "sourceType": "Financial press report on a stock-exchange delisting", "publishedDate": "2023-08-02", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "shinhung", "type": "brand", "name": "Shinhung", "url": "https://dental-implants-guide.com/brands/shinhung/", "aliases": [ "Luna", "Shinhung MST" ], "definition": "The implant brand associated with South Korea’s Shinhung, made by Shinhung MST, whose main implant line is Luna.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Shinhung MST Co., Ltd.", "sources": [ { "sourceId": "fda-k223395-shinhung-luna" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k223395-shinhung-luna" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal hex (Luna Dental Implant System)", "sources": [ { "sourceId": "fda-k172345-warantec-iu" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "material": { "kind": "verified_fact", "value": "Grade-4 commercially pure titanium fixture (ASTM F67)", "sources": [ { "sourceId": "fda-k223395-shinhung-luna" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K223395", "holder": "Shinhung Mst Co., Ltd.", "deviceName": "Luna Dental Implant System", "date": "2023-02-03", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K200189", "holder": "Shinhung Mst Co., Ltd.", "deviceName": "Luna Dental Implant System- Healing Abutment", "date": "2020-02-26", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K160106", "holder": "Shinhung Mst Co., Ltd.", "deviceName": "LUNA DENTAL IMPLANT SYSTEM", "date": "2016-08-26", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K123155", "holder": "Shinhung Mst Co., Ltd.", "deviceName": "LUNA DENTAL IMPLANT SYSTEM", "date": "2013-10-31", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3006948193", "holder": "Shinhung MST Co., Ltd.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "307 device records", "holder": "Shinhung", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Safe (92); MR Conditional (82); Labeling does not contain MRI Safety Information (26). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k223395-shinhung-luna", "title": "FDA 510(k) K223395 — Luna Dental Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf22/K223395.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2023-02-03", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "fda-k172345-warantec-iu", "title": "FDA 510(k) K172345 — IU Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172345.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2018-06-18", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "southern-implants", "type": "brand", "name": "Southern Implants", "url": "https://dental-implants-guide.com/brands/southern-implants/", "aliases": [ "Southern Implants (Pty) Ltd", "SInergy" ], "definition": "The implant brand of the South African manufacturer Southern Implants, known for site-specific designs including zygomatic and pterygoid implants.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Southern Implants (Pty) Ltd", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Southern Implants (Pty) Ltd, privately owned", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Africa", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "1 Albert Road, Irene, South Africa", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "1987, by the engineer Graham Blackbeard", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "material": { "kind": "manufacturer_claim", "value": "The manufacturer states that its implants are made from commercially pure grade IV titanium to ASTM F67", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "manufacturer_claim", "value": "SInergy, the manufacturer’s own surface treatment", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Range includes external hex, internal hex, deep conical and tapered bodies, plus site-specific zygomatic, pterygoid, anterior and molar designs", "sources": [ { "sourceId": "southern-implants-profile" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Africa", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K191054", "holder": "Southern Implants (Pty), Ltd.", "deviceName": "Southern Implants MAX Implant System", "date": "2019-12-09", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3003394627", "holder": "SOUTHERN IMPLANTS (PTY) LTD", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Africa. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "954 device records", "holder": "Southern Implants", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 200 are supplied sterile, 0 are supplied non-sterile and 0 do not state it. MRI safety labelling: MR Conditional (200). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "southern-implants-profile", "title": "Profile — Southern Implants", "publisher": "Southern Implants (Pty) Ltd", "url": "https://southernimplants.com/profile/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "straumann", "type": "brand", "name": "Straumann", "url": "https://dental-implants-guide.com/brands/straumann/", "aliases": [ "Straumann Dental Implant System" ], "definition": "The premium implant brand of the Straumann Group and the marque under which the Straumann Dental Implant System and the iEXCEL range are sold.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Straumann Group (Straumann Holding AG)", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "Straumann Holding AG, Basel, Switzerland", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Basel, Switzerland", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "Institut Straumann was founded in 1954 in Waldenburg, Switzerland; the business was refocused exclusively on dental implantology in 1990", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "status": { "kind": "verified_fact", "value": "Current — the group’s flagship implant brand", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "positioning": { "kind": "manufacturer_claim", "value": "Positioned by the group in the global premium implant segment, alongside Neodent in the value segment", "sources": [ { "sourceId": "straumann-annual-report-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" } }, "certifications": [ { "type": "fda_510k", "number": "K252168", "holder": "Institut Straumann AG", "deviceName": "Straumann® BLC Implants - Indication Widening", "date": "2026-03-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K250294", "holder": "Institut Straumann AG", "deviceName": "Straumann® RidgeFit Implants", "date": "2025-08-12", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K241391", "holder": "Institut Straumann AG", "deviceName": "Straumann® PURE Ceramic Implants", "date": "2024-12-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K234049", "holder": "Institut Straumann AG", "deviceName": "Straumann® BLC and TLC Implants - Line extension", "date": "2024-03-20", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K230108", "holder": "Institut Straumann AG", "deviceName": "Straumann® BLC and TLC Implants", "date": "2023-09-14", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K223083", "holder": "Institut Straumann AG", "deviceName": "Straumann SLActive labeling changes", "date": "2023-06-22", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K211052", "holder": "Institut Straumann AG", "deviceName": "Straumann RidgeFit Implants", "date": "2021-07-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K210855", "holder": "Institut Straumann AG", "deviceName": "Straumann BLX Implant System", "date": "2021-06-21", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K202942", "holder": "Straumann USA, LLC", "deviceName": "Straumann 4 mm Short Implants", "date": "2021-02-08", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K200586", "holder": "Institut Straumann AG", "deviceName": "Straumann TLX Implant System", "date": "2020-08-20", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K191256", "holder": "Institut Straumann AG", "deviceName": "Straumann BLX Ø3.5 mm Implants", "date": "2019-12-27", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K191895", "holder": "Institut Straumann AG", "deviceName": "Straumann Mini Implants", "date": "2019-12-09", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K190662", "holder": "Straumann USA, LLC", "deviceName": "MRI Compatibility for Existing Straumann Dental Implant Systems", "date": "2019-06-17", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K180477", "holder": "Institut Straumann AG", "deviceName": "Straumann PURE Ceramic Implant System", "date": "2019-01-04", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K181703", "holder": "Institut Straumann AG", "deviceName": "Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments", "date": "2018-12-28", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K173961", "holder": "Institut Straumann AG", "deviceName": "Straumann BLX Implant System", "date": "2018-06-05", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171784", "holder": "Straumann USA, LLC", "deviceName": "Straumann Dental Implant System", "date": "2018-01-19", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K171769", "holder": "Straumann USA, LLC (On Behalf of Institut Straumann Ag)", "deviceName": "Straumann PURE Ceramic Implants", "date": "2017-11-14", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K153758", "holder": "Institut Straumann AG", "deviceName": "Straumann Bone Level Tapered Implants", "date": "2016-03-23", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K150938", "holder": "Straumann USA, LLC", "deviceName": "Straumann® Dental Implant System ¿ Roxolid® SLA Implants", "date": "2015-07-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K140878", "holder": "Straumann USA, LLC", "deviceName": "STRAUMANN BONE LEVEL TAPERED IMPLANT", "date": "2014-08-20", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K130222", "holder": "Straumann USA, LLC", "deviceName": "STRAUMANN DENTAL IMPLANT SYSTEM", "date": "2013-04-29", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K123784", "holder": "Straumann USA, LLC", "deviceName": "STRAUMANN DENTAL IMPLANT SYSTEM", "date": "2013-04-10", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K111357", "holder": "Straumann USA", "deviceName": "STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM", "date": "2011-10-03", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K093027", "holder": "Straumann USA", "deviceName": "STRAUMANN RC TEMPORARY ABUTMENTS", "date": "2010-02-12", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K083550", "holder": "Straumann USA", "deviceName": "STRAUMANN DENTAL IMPLANT SYSTEM", "date": "2009-02-26", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K081419", "holder": "Institut Straumann AG", "deviceName": "STRAUMANN DENTAL IMPLANT SYSTEM", "date": "2009-02-20", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K060958", "holder": "Straumann USA", "deviceName": "STRAUMANN NARROW NECK IMPLANTS", "date": "2006-08-24", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K061176", "holder": "Institut Straumann AG", "deviceName": "STRAUMANN DENTAL IMPLANTS", "date": "2006-08-11", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K033984", "holder": "Institut Straumann AG", "deviceName": "STRAUMANN DENTAL IMPLANT SYSTEM", "date": "2004-06-30", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1219 device records", "holder": "Straumann", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 93 are supplied sterile, 7 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (52); MR Conditional (48). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "straumann-annual-report-2025", "title": "Straumann Group Annual Report 2025", "publisher": "Straumann Holding AG", "url": "https://www.straumann.com/content/dam/media-center/group/en/documents/annual-report/2025/Straumann_AR25.pdf", "tier": "manufacturer_primary", "sourceType": "Audited annual report, including the statutory list of group companies", "publishedDate": "2026", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "thommen", "type": "brand", "name": "Thommen SPI", "url": "https://dental-implants-guide.com/brands/thommen/", "aliases": [ "Thommen", "SPI", "Thommen Medical" ], "definition": "The Swiss dental implant brand of Thommen Medical, comprising the ELEMENT, CONTACT and NEVO implant lines.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Thommen Medical AG", "sources": [ { "sourceId": "thommen-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "thommen-about" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "SPI implant system offered in three lines — ELEMENT, CONTACT and NEVO — that share one surgical procedure", "sources": [ { "sourceId": "thommen-products" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "manufacturingCountry": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K171795", "holder": "Thommen Medical AG", "deviceName": "Thommen Implant System", "date": "2017-09-29", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K151984", "holder": "Thommen Medical AG", "deviceName": "Thommen Milling Abutment for CAD/CAM", "date": "2016-03-10", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3003184527", "holder": "THOMMEN MEDICAL, AG", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Switzerland. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "243 device records", "holder": "Thommen SPI", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 200 records we inspected, 190 are supplied sterile, 10 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (142); MR Conditional (58). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "thommen-about", "title": "About us — Thommen Medical", "publisher": "Thommen Medical AG", "url": "https://www.thommenmedical.com/us-en/about-us", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "thommen-products", "title": "Products and solutions — Thommen Medical", "publisher": "Thommen Medical AG", "url": "https://www.thommenmedical.com/us-en/dental-professionals/products-and-solutions", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "trausim", "type": "brand", "name": "Trausim", "url": "https://dental-implants-guide.com/brands/trausim/", "aliases": [ "Trausim Dental Implant System" ], "definition": "The implant brand of Jiangsu Trausim Medical Instrument Co., Ltd. of China, covering bone-level and tissue-level fixtures.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Jiangsu Trausim Medical Instrument Co., Ltd.", "sources": [ { "sourceId": "fda-k140202-trausim" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "China", "sources": [ { "sourceId": "fda-k140202-trausim" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "diameters": { "kind": "unknown", "reason": "manufacturer_documentation_not_located", "note": "Fixture diameters are not listed in the public FDA 510(k) summary and we did not locate manufacturer documentation stating them." }, "lengths": { "kind": "unknown", "reason": "manufacturer_documentation_not_located" }, "manufacturingCountry": { "kind": "verified_fact", "value": "China", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K140202", "holder": "Jiangsu Trausim Medical Instrument", "deviceName": "TRAUSIM DENTAL IMPLANT SYSTEM", "date": "2014-12-12", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3011587077", "holder": "JIANGSU TRAUSIM MEDICAL INSTRUMENT CO.,LTD.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in China. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k140202-trausim", "title": "FDA 510(k) K140202 — Trausim Dental Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140202.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2014-12-12", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "warantec", "type": "brand", "name": "Warantec", "url": "https://dental-implants-guide.com/brands/warantec/", "aliases": [ "Oneplant", "IU Implant" ], "definition": "The implant brand of Warantec Co., Ltd. of South Korea, covering the Oneplant and IU implant systems.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Warantec Co., Ltd.", "sources": [ { "sourceId": "fda-k172345-warantec-iu" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "fda-k172345-warantec-iu" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "founded": { "kind": "verified_fact", "value": "2001", "sources": [ { "sourceId": "straumann-warantec-2019" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "surface": { "kind": "verified_fact", "value": "SA (sandblasted and acid-etched) on grade-4 commercially pure titanium (IU Implant System)", "sources": [ { "sourceId": "fda-k172345-warantec-iu" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "connection": { "kind": "verified_fact", "value": "Internal hex (2.1 / 2.5 mm) on the IU Implant System", "sources": [ { "sourceId": "fda-k172345-warantec-iu" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "South Korea", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "fda_510k", "number": "K221972", "holder": "Warantec Co., Ltd.", "deviceName": "Warantec Custom Abutment", "date": "2023-10-02", "productCode": "NHA", "productCodeMeaning": "Abutment, Implant, Dental, Endosseous (Class II, 21 CFR 872.3630)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K172345", "holder": "Warantec Co., Ltd.", "deviceName": "IU Implant System", "date": "2018-06-18", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "fda_510k", "number": "K081748", "holder": "Warantec Co., Ltd.", "deviceName": "ONEPLANT DENTAL IMPLANT SYSTEM", "date": "2009-03-27", "productCode": "DZE", "productCodeMeaning": "Implant, Endosseous, Root-Form (Class II, 21 CFR 872.3640)", "authority": "US Food and Drug Administration", "meaning": "Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.", "sourceId": "openfda-510k", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3009514134", "holder": "WARANTEC Co., Ltd.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "fda-k172345-warantec-iu", "title": "FDA 510(k) K172345 — IU Implant System", "publisher": "U.S. Food & Drug Administration", "url": "https://www.accessdata.fda.gov/cdrh_docs/pdf17/K172345.pdf", "tier": "regulator", "sourceType": "510(k) premarket notification", "publishedDate": "2018-06-18", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "straumann-warantec-2019", "title": "Straumann Group partners with Korea’s leading pharmaceutical corporation to drive international expansion of Warantec dental implants", "publisher": "Straumann Group", "url": "https://www.straumann.com/dam/data/media-release/en/2019/5f023ce6-3753-4d9b-8a02-715129e4b4dc/Warantec_EN.pdf", "tier": "trade_publication", "sourceType": "Corporate press release", "publishedDate": "2019-07-30", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-510k", "title": "openFDA — Device 510(k) clearances database", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/510k/", "tier": "regulator", "sourceType": "Government device clearance database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "z-systems", "type": "brand", "name": "Z-Systems", "url": "https://dental-implants-guide.com/brands/z-systems/", "aliases": [ "Z-SYSTEMS" ], "definition": "A Swiss brand of metal-free zirconia ceramic dental implants, including the two-piece Z5 range.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "Z-Systems AG", "sources": [ { "sourceId": "zsystems-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "zsystems-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "material": { "kind": "manufacturer_claim", "value": "Zirconium-oxide ceramic (100% metal-free)", "sources": [ { "sourceId": "zsystems-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Ceramic implants including the two-piece, screw-retained Z5 bone-level and tissue-level implants", "sources": [ { "sourceId": "zsystems-home" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "zsystems-home", "title": "Z-SYSTEMS — Pioneering ceramic dental implants", "publisher": "Z-Systems AG", "url": "https://www.zsystems.com/", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate site", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "zeramex", "type": "brand", "name": "ZERAMEX", "url": "https://dental-implants-guide.com/brands/zeramex/", "aliases": [ "Zeramex" ], "definition": "A Swiss brand of two-piece, screw-retained, metal-free ceramic (zirconia) dental implants.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "CeramTec Switzerland LLC, formerly Dentalpoint AG", "sources": [ { "sourceId": "zeramex-company" }, { "sourceId": "zeramex-milestones" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "country": { "kind": "verified_fact", "value": "Switzerland", "sources": [ { "sourceId": "zeramex-company" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "material": { "kind": "manufacturer_claim", "value": "High-performance zirconia (ATZ, alumina-toughened zirconia)", "sources": [ { "sourceId": "zeramex-xt" } ], "confidence": "high", "verifiedAt": "2026-07-22" }, "positioning": { "kind": "manufacturer_claim", "value": "Metal-free two-piece ceramic implant system with a reversible screw fixation", "sources": [ { "sourceId": "zeramex-xt" } ], "confidence": "high", "verifiedAt": "2026-07-22" } }, "certifications": [], "sources": [ { "id": "zeramex-company", "title": "About CeramTec Switzerland LLC", "publisher": "CeramTec Switzerland LLC (Dentalpoint AG)", "url": "https://www.zeramex.com/en/about/company.php", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "zeramex-milestones", "title": "Milestones in dental implantology — Dentalpoint", "publisher": "CeramTec Switzerland LLC (Dentalpoint AG)", "url": "https://www.zeramex.com/en/about_dentalpoint/milestones.php", "tier": "manufacturer_primary", "sourceType": "Manufacturer corporate history page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "zeramex-xt", "title": "Zirconia implants ZERAMEX XT", "publisher": "CeramTec Switzerland LLC (Dentalpoint AG)", "url": "https://www.zeramex.com/us/dental_professionals/implant_systems_xt.php", "tier": "manufacturer_primary", "sourceType": "Manufacturer product page", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] }, { "id": "zimvie-dental", "type": "brand", "name": "ZimVie Dental", "url": "https://dental-implants-guide.com/brands/zimvie-dental/", "aliases": [ "ZimVie", "Zimmer Biomet Dental" ], "definition": "The dental implant brand of ZimVie, carrying the T3, T3 PRO, TSX and Eztetic implant lines that descend from Zimmer Dental and Biomet 3i.", "specs": { "manufacturer": { "kind": "verified_fact", "value": "ZimVie Inc.", "sources": [ { "sourceId": "zimvie-we-are-zimvie" }, { "sourceId": "zimvie-dental-home" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "parentCompany": { "kind": "verified_fact", "value": "ARCHIMED, which completed its acquisition of ZimVie on 20 October 2025", "sources": [ { "sourceId": "zimvie-archimed-completion-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "country": { "kind": "verified_fact", "value": "United States", "sources": [ { "sourceId": "zimvie-archimed-completion-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "headquarters": { "kind": "verified_fact", "value": "Palm Beach Gardens, Florida, United States", "sources": [ { "sourceId": "zimvie-archimed-completion-2025" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "ownership": { "kind": "verified_fact", "value": "Private since October 2025. ZimVie separated from Zimmer Biomet in 2021 as a listed company and was acquired by ARCHIMED in 2025, ending its Nasdaq listing", "sources": [ { "sourceId": "zimvie-archimed-completion-2025" }, { "sourceId": "zimvie-we-are-zimvie" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "predecessor": { "kind": "verified_fact", "value": "Zimmer entered dentistry in 2003 by acquiring Centerpulse AG; Biomet acquired Implant Innovations (3i) in 1999; the two companies merged in 2011 to form Zimmer Biomet", "sources": [ { "sourceId": "zimvie-we-are-zimvie" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "prosthetics": { "kind": "manufacturer_claim", "value": "Implant lines named by the manufacturer include T3, T3 PRO, TSX, Eztetic and an immediate molar implant, supported by Encode impressions and GenTek restorative components", "sources": [ { "sourceId": "zimvie-we-are-zimvie" }, { "sourceId": "zimvie-dental-home" } ], "confidence": "high", "verifiedAt": "2026-07-21" }, "manufacturingCountry": { "kind": "verified_fact", "value": "United States, Canada, Spain", "sources": [ { "sourceId": "openfda-registration" } ], "confidence": "high", "verifiedAt": "2026-07-22", "note": "Country of the FDA-registered device establishment, which may differ from the brand’s home country." } }, "certifications": [ { "type": "other", "number": "1038806", "holder": "ZimVie US Corp LLC", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in United States. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1000244346", "holder": "ZimVie Canada Inc.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Canada. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3009840806", "holder": "ZimVie Spain S.L.U.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Spain. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "3006411780", "holder": "ZimVie Spain S.L.U.", "authority": "US Food and Drug Administration — establishment registration", "meaning": "Registered device establishment in Spain. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.", "sourceId": "openfda-registration", "verifiedAt": "2026-07-22" }, { "type": "other", "number": "1492 device records", "holder": "ZimVie Dental", "authority": "US FDA Global UDI Database (GUDID)", "meaning": "Of 100 records we inspected, 79 are supplied sterile, 21 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (53); MR Conditional (47). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.", "sourceId": "openfda-udi", "verifiedAt": "2026-07-22" } ], "sources": [ { "id": "zimvie-we-are-zimvie", "title": "We Are ZimVie", "publisher": "ZimVie Inc.", "url": "https://www.zimvie.com/en/about-us/we-are-zimvie.html", "tier": "manufacturer_primary", "sourceType": "Corporate history and profile page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "zimvie-dental-home", "title": "ZimVie Dental — homepage", "publisher": "ZimVie Inc.", "url": "https://www.zimvie.com/en", "tier": "manufacturer_primary", "sourceType": "Manufacturer product overview page", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "zimvie-archimed-completion-2025", "title": "ZimVie Announces Completion of its Acquisition by ARCHIMED", "publisher": "ZimVie Inc.", "url": "https://www.zimvie.com/en/about-us/media-releases/zimvie_announces_completion_of_its_acquisition_by_archimed.html", "tier": "manufacturer_primary", "sourceType": "Corporate media release", "publishedDate": "2025-10-20", "accessedDate": "2026-07-21", "verificationStatus": "reachable" }, { "id": "openfda-registration", "title": "openFDA — Device registrations and listings", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/registrationlisting/", "tier": "regulator", "sourceType": "Government establishment registration database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" }, { "id": "openfda-udi", "title": "openFDA — Global Unique Device Identification Database (GUDID)", "publisher": "US Food and Drug Administration", "url": "https://open.fda.gov/apis/device/udi/", "tier": "regulator", "sourceType": "Government device identification database (API)", "accessedDate": "2026-07-22", "verificationStatus": "reachable" } ] } ] }