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Straumann

Also known as: Straumann Dental Implant System

The premium implant brand of the Straumann Group and the marque under which the Straumann Dental Implant System and the iEXCEL range are sold.

Key facts

ManufacturerStraumann Group (Straumann Holding AG)Verified spec[1]
Parent companyStraumann Holding AG, Basel, SwitzerlandVerified spec[1]
CountrySwitzerlandVerified spec[1]
HeadquartersBasel, SwitzerlandVerified spec[1]
FoundedInstitut Straumann was founded in 1954 in Waldenburg, Switzerland; the business was refocused exclusively on dental implantology in 1990Verified spec[1]
Current statusCurrent — the group’s flagship implant brandVerified spec[1]
Manufacturer-described indicationPositioned by the group in the global premium implant segment, alongside Neodent in the value segmentManufacturer-reported[1]

Overview

Straumann is a brand, not a company — the company is Straumann Group, which also owns Neodent, Anthogyr and Medentika. That matters because a quotation offering “a Straumann Group implant” may not be a Straumann-branded implant at all. Within the brand itself there are several distinct systems, historically the tissue-level and bone-level lines and more recently the iEXCEL range, and they use different prosthetic connections. If you are keeping records for future maintenance, the useful information is the system name and the connection, not the brand alone.

Regulatory record

Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →

FDA 510(k) clearance30 records

Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.

NumberDeviceHolderDate
K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG2026-03-10
K250294Straumann® RidgeFit ImplantsInstitut Straumann AG2025-08-12
K241391Straumann® PURE Ceramic ImplantsInstitut Straumann AG2024-12-10
K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG2024-03-20
K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG2023-09-14
K223083Straumann SLActive labeling changesInstitut Straumann AG2023-06-22
K211052Straumann RidgeFit ImplantsInstitut Straumann AG2021-07-08
K210855Straumann BLX Implant SystemInstitut Straumann AG2021-06-21
K202942Straumann 4 mm Short ImplantsStraumann USA, LLC2021-02-08
K200586Straumann TLX Implant SystemInstitut Straumann AG2020-08-20
K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG2019-12-27
K191895Straumann Mini ImplantsInstitut Straumann AG2019-12-09
K190662MRI Compatibility for Existing Straumann Dental Implant SystemsStraumann USA, LLC2019-06-17
K180477Straumann PURE Ceramic Implant SystemInstitut Straumann AG2019-01-04
K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG2018-12-28
K173961Straumann BLX Implant SystemInstitut Straumann AG2018-06-05
K171784Straumann Dental Implant SystemStraumann USA, LLC2018-01-19
K171769Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag)2017-11-14
K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG2016-03-23
K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC2015-07-24
K140878STRAUMANN BONE LEVEL TAPERED IMPLANTStraumann USA, LLC2014-08-20
K130222STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA, LLC2013-04-29
K123784STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA, LLC2013-04-10
K111357STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEMStraumann USA2011-10-03
K093027STRAUMANN RC TEMPORARY ABUTMENTSStraumann USA2010-02-12
K083550STRAUMANN DENTAL IMPLANT SYSTEMStraumann USA2009-02-26
K081419STRAUMANN DENTAL IMPLANT SYSTEMInstitut Straumann AG2009-02-20
K060958STRAUMANN NARROW NECK IMPLANTSStraumann USA2006-08-24
K061176STRAUMANN DENTAL IMPLANTSInstitut Straumann AG2006-08-11
K033984STRAUMANN DENTAL IMPLANT SYSTEMInstitut Straumann AG2004-06-30

Other1 record

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.

NumberDeviceHolderDate
1219 device records—Straumann—

Clearance records for Straumann were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Straumann.

Sources

Numbers match the citations beside each claim above.

Primary sources

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