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Ankylos

Also known as: ANKYLOS

One of the long-standing implant brands in the Dentsply Sirona portfolio, sold alongside the Astra Tech and Xive lines.

Research in progress. Some fields on this entry are not yet verified against a primary source, so we have left them blank rather than filling them in — and this page is not published to search engines until they are.

Key facts

ManufacturerDENTSPLY SIRONA Inc.Verified spec[1][2][3]
Parent companyDENTSPLY SIRONA Inc., Charlotte, North CarolinaVerified spec[4]
Current statusCurrent — listed among Dentsply Sirona’s implant systemsVerified spec[2][1]
FoundedManufacturer documentation not located(We have not confirmed the origin date of the Ankylos system from a primary source)
CountryRequires manual verification(Commonly described as German in origin; not confirmed here from a primary source)
Manufacturer-described indicationPresented by Dentsply Sirona as a system aimed at anterior aesthetic outcomesManufacturer-reported[2]

Overview

Ankylos is one of three older implant marques Dentsply Sirona kept running in parallel rather than merging into a single line, the others being Astra Tech and Xive. Keeping them separate has a practical effect that outlives any marketing decision: the connections differ, so a laboratory restoring an Ankylos implant needs Ankylos components specifically. We hold this record as database-only rather than repeat the widely circulated technical descriptions of the system — its connection geometry in particular — because we have not yet confirmed them against a manufacturer document, and this is precisely the kind of detail that is reported confidently and incorrectly.

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) clearance5 records

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

NumberDeviceHolderDate
K131644ANKYLOS SYNCONE ABUTMENT 5(DEGREE)Dentsply International, Inc.2014-01-22
K122268ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOSDentsply International2012-12-11
K073075FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMSDentsply International, Inc.2008-03-31
K073067ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMSDentsply International, Inc.2008-02-15
K073073ANKYLOS TEMPORARY ABUTMENT BALANCEDentsply International, Inc.2008-02-12

Clearance records for Ankylos 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 Ankylos.

Sources

Numbers match the citations beside each claim above.

Primary sources

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