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Implance

Also known as: Implance Dental Implant System

The dental implant brand of Turkey’s AGS Medikal, offering bone-level, tissue-level and short implants built around an internal conical connection.

Key facts

ManufacturerAGS Medikal Ürünleri İth. İhr. Tic. A.Ş.Verified spec[1][5]
CountryTurkeyVerified spec[1]
ConnectionInternal 11-degree conical (Morse-taper) connection with platform switchingManufacturer-reported[2]
SurfaceRBM — a resorbable-blasting-media roughened surfaceManufacturer-reported[3][4]
Manufacturer-described indicationPresented as a hybrid cylindrical/conical implant system covering bone-level, tissue-level and short indicationsManufacturer-reported[4]

Overview

Implance is the implant brand of AGS Medikal and is one of the more internationally visible Turkish systems, helped by its US FDA clearance. Its implants use a hybrid body — tapered towards the apex, cylindrical at the neck — with an internal conical connection and a resorbable-blasting-media (RBM) surface rather than the sandblasted-and-acid-etched finish common elsewhere. The range covers bone-level, tissue-level, an aggressive-threaded "Aggressor" variant and short implants, so the single brand name spans several quite different fixtures.

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) clearance1 record

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

NumberDeviceHolderDate
K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.2016-09-12

Clearance records for Implance 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 Implance.

Sources

Numbers match the citations beside each claim above.

Primary sources

Additional references

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