Manufacturer registered with FDA
Teknimed
Vic en Bigorre, France. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 22007–2009
- Markets registered in
- 17235 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2000–2026
Registered in 17 markets
Where regulators' registries name Teknimed as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Teknimed | 2 clearances | 2007–2009 | Below |
| Colombia | INVIMA | Manufacturer | TEKNIMED S.A.S.TEKNIMED SAS · TEKNIMED S.A.S | 63 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | TEKNIMED S.A.STEKNIMED S.A.S. | 24 | 2017–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | TEKNIMED SAS | 23 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | TEKNIMED SASTEKNIMED S.A.S. · Teknimed SAS | 18 | 2009–2026 | Pure Global AI |
| European Union | EUDAMED | Registration holder | TEKNIMED SAS | 17 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | TEKNIMED SAS | 17 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | TEKNIMED SASTeknimed SAS | 13 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | TEKNIMED SASTEKNIMED S.A.S. | 12 | 2019–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Teknimed SAS | 11 | 2015–2025 | Pure Global AI |
| Egypt | EDA | Manufacturer | TEKNIMED SAS,TEKNIMED S.A.S, · teknimed sas, | 10 | 2023–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Teknimed SASTEKNIMED · TEKNIMED S.A.S | 9 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | TEKNIMED SAS | 5 | 2023–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Teknimed S.A.S.TEKNIMED S.A.S · TEKNIMED S.A.S. | 5 | 2006–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | TEKNIMED SAS | 4 | 2022–2024 | Pure Global AI |
| China | NMPA | Registration holder | TEKNIMED S.A.S. 泰科美简化合股公司泰科美简化合股公司TEKNIMED S.A.S · 泰科美简化合股公司TEKNIMED S.A.S. | 3 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | TEKNIMED SAS | 1 | 2019–2019 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Teknimed currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Synthetic Bone Grafting MaterialLYC · Class 2 | Bone grafts & membranes | Maker | — | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| TEKNIMED SASFDA reg. 9615788 | L Union Haute-Garonne, France | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9040657). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.