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Dentsply Sirona

Also known as: DENTSPLY SIRONA Inc., Dentsply

The Nasdaq-listed dental manufacturer that owns the Astra Tech, Ankylos, Xive and MIS implant brands, reported within its Orthodontic and Implant Solutions segment.

Key facts

HeadquartersCharlotte, North Carolina, United StatesVerified spec[1]
CountryUnited StatesVerified spec[1]
FoundedThe company reports a 139-year history of innovation and service to the dental industry in its 2025 annual filingVerified spec[1]We have not attached a primary source for the specific incorporation date of the present entity
OwnershipPublicly listed. Common stock trades on the Nasdaq stock market under the ticker XRAYVerified spec[1]
BrandImplant brands: Astra Tech Implant System, Ankylos, Xive and MISVerified spec[2][3][4]
Current statusImplants are reported inside the Orthodontic and Implant Solutions segment, one of four reportable segmentsVerified spec[1]
Manufacturer-described indicationRuns its implant brands as deliberately distinct organisations and portfolios, targeting the premium and value segments separately rather than merging them into one rangeManufacturer-reported[4][3]

Overview

Dentsply Sirona holds four implant marques that reached it by different routes, which is why they share so little engineering. Astra Tech came from AstraZeneca’s medical devices arm in Sweden; Ankylos and Xive have German origins; MIS was an Israeli company bought outright in 2016. The group has since consolidated its newer implants into the EV family around a single prosthetic connection, but the older Ankylos and Xive platforms remain distinct, so parts are not shared across the portfolio. For a patient, the practical consequence is that “a Dentsply implant” is not a specification — the brand and the system name are what a future dentist will need in order to order the right components.

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) clearance49 records

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

NumberDeviceHolderDate
K252343Atlantis® Abutments in TitaniumDentsply Sirona2025-12-09
K252248CEREC Tessera Abutment SystemDentsply Sirona2025-11-26
K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona2025-11-21
K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection SystemDentsply Sirona, Inc.2025-08-21
K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.2025-07-24
K250295Dentsply Sirona Titanium Bases systemDentsply Sirona2025-04-30
K250081Atlantis® Abutments in TitaniumDentsply Sirona2025-04-11
K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.2024-11-25
K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona2024-05-07
K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.2023-03-22
K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona2022-11-16
K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona2022-11-16
K213432MIS Angulated multi-unit abutmentsDentsply Sirona2022-04-01
K213449DS Implants abutments provided with the EV connectionDentsply Sirona2021-11-15
K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.2021-08-27
K211225MIS Ti-base abutmentDentsply Sirona2021-07-28
K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona2021-06-17
K200102MIS Dental Implant SystemDentsply Sirona2020-09-03
K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona2020-08-16
K191152MIS Ti-base AbutmentDentsply Sirona2020-07-06
K193078MIS CONNECT Conical Connection SystemDentsply Sirona2020-03-25
K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona2020-03-05
K193064Atlantis suprastructuresDentsply Sirona, Inc.2020-03-03
K192149MIS Dental Implant SystemDentsply Sirona, Inc.2019-12-11
K183079Conometric AbutmentsDentsply Sirona, Inc.2019-07-10
K181520Sirona Dental CAD/CAM SystemDentsply Sirona2018-10-11
K181189ATLANTIS Conus StructureDentsply Sirona2018-07-18
K172225Atlantis Abutment for MIS ImplantDentsply Sirona2017-11-30
K163398ATLANTIS suprastructuresDentsply Sirona2017-08-14
K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona2017-03-31
K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.2016-09-21
K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona2016-08-29
K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona2016-08-26
K151439ATLANTIS ISUSDentsply International, Inc.2016-02-19
K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.2016-01-14
K140347ANKYLOS C/X IMPLANT SYSTEMDentsply Intl., Inc.2014-08-20
K131644ANKYLOS SYNCONE ABUTMENT 5(DEGREE)Dentsply International, Inc.2014-01-22
K130999OSSEOSPEED PROFILE EVDentsply Implants Manufacturing GmbH2013-10-25
K122424ISUS IMPLANT SUPRASTRUCTURESDentsply International, Inc.2013-07-05
K130216ATLANTIS STRAUMANN BONE LEVEL ABUTMENTDentsply Implant2013-05-01

Showing the 40 most recent of 49. The full set is searchable in the authority's own database.

Other1 record

Of 100 records we inspected, 32 are supplied sterile, 68 are supplied non-sterile and 0 do not state it. MRI safety labelling: Labeling does not contain MRI Safety Information (98); MR Conditional (2). A UDI listing records what the manufacturer declared about the device; it is not a clearance or an approval.

NumberDeviceHolderDate
1827 device records—Dentsply Sirona—

Clearance records for Dentsply Sirona 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 Dentsply Sirona.

Sources

Numbers match the citations beside each claim above.

Primary sources

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