AGS Medikal

Also known as: AGS Medikal Ürünleri İth. İhr. Tic. A.Ş., AGS Medical

The Turkish medical-device company that manufactures the Implance dental implant system, with its implant factory in Trabzon.

Key facts

Country	TurkeyVerified spec[1]
Headquarters	İstanbul, Turkey, with the implant factory in the Beşikdüzü Organised Industrial Zone, TrabzonVerified spec[1]
Founded	2007 (İstanbul); implant production in Trabzon from 2010Verified spec[1]
Ownership	Turkish joint-stock company (Anonim Şirket / A.Ş.)Verified spec[3]
regulatoryApproval	FDA 510(k) K160221, cleared 12 September 2016, for the Implance Dental Implant System and Abutment System (product code DZE)Verified spec[2]
Geographic availability	Stated to export to more than 50 countriesManufacturer-reported[1]

Overview

AGS Medikal is the corporate maker behind the Implance brand: the company was set up in İstanbul in 2007 and built its implant factory in Beşikdüzü, Trabzon, from 2010. It is one of the few Turkish implant firms with a US FDA 510(k) clearance on record, which is why Implance appears in some export markets that most domestic Turkish brands do not reach. As with any manufacturer, an FDA clearance means the device was found substantially equivalent to an existing one for marketing purposes; it is a regulatory step, not a measure of clinical outcome.

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.

Number	Device	Holder	Date
K160221	Implance Dental Implant System, Implance Dental Abutment System	Ags Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.	2016-09-12

Clearance records for AGS Medikal 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 AGS Medikal.

Sources

Numbers match the citations beside each claim above.

Primary sources

[1]Hakkımızda — Implance (AGS Medikal) — AGS Medikal Ürünleri İth. İhr. Tic. A.Ş.. Accessed 2026-07-22.
[2]FDA 510(k) K160221 — Implance Dental Implant System — U.S. Food and Drug Administration, 2016. Accessed 2026-07-22.

Additional references

[3]Üyelerimiz (Members) — İMPLANTDER — Dental İmplant Sanayici ve İş İnsanları Derneği (İMPLANTDER). Accessed 2026-07-22.