Manufacturer registered with FDA
CeramTec GmbH
Plochingen, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 511 registrations outside the US
- Establishments
- 1Germany
Registered in 5 markets
Where regulators' registries name CeramTec GmbH 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 | CeramTec GmbH | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | CeramTec AGCeramTec GmbH | 6 | 2003–2012 | Pure Global AI |
| Australia | TGA | Manufacturer | Ceramtec GmbH | 2 | 2014–2014 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | CERAMTEC GMBH | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CERAMTEC GMBH | 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 CeramTec GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | — | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | — | 2021 |
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 |
|---|---|---|
| CERAMTEC GMBHFDA reg. 3008886124 | Lauf an der Pegnitz Bavaria, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9066049). 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.