Manufacturer registered with FDA
biotrics bioimplants AG
Berlin, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 628 registrations outside the US
- Establishments
- 1Germany
Registered in 6 markets
Where regulators' registries name biotrics bioimplants AG 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 | biotrics bioimplants AG | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | biotrics bioimplants AG | 21 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIOTRICS BIOIMPLANTS AG | 4 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Biotrics Bioimplants AG | 1 | 2025–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | biotrics bioimplants AG | 1 | 2014–2014 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Biotrics Bioimplants AG | 1 | — | 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 biotrics bioimplants AG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Jason membraneStraumann Jason membrane | 2026 |
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 |
|---|---|---|
| BIOTRICS BIOIMPLANTS AGFDA reg. 3030833497 | Berlin, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094181). 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.