Not currently registered with FDA under this name
Doceram Medical Ceramics GmbH
Dortmund, Nrw, Germany. Named as applicant on 2 dental 510(k) clearances between 2008 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22008–2015
- Markets registered in
- 728 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Doceram Medical Ceramics 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 | Applicant | Doceram Medical Ceramics GmbH | 2 clearances | 2008–2015 | Below |
| Saudi Arabia | SFDA | Manufacturer | Doceram Medical Ceramics GmbH | 16 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | DOCERAM MEDICAL CERAMICS GMBH | 4 | — | Pure Global AI |
| Japan | PMDA | Registration holder | ＤＯＣＥＲＡＭ Ｍｅｄｉｃａｌ Ｃｅｒａｍｉｃｓ ＧｍｂＨ | 4 | 2016–2020 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DOCERAM Medical Ceramics GmbH | 2 | 2013–2013 | Pure Global AI |
| Australia | TGA | Manufacturer | Doceram Medical Ceramics GmbH | 1 | 2021–2021 | Pure Global AI |
| Canada | Health Canada | Registration holder | DOCERAM MEDICAL CERAMICS GMBH | 1 | 2018–2018 | 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
510(k) clearances
Clearances on which FDA names Doceram Medical Ceramics GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Jun 2015 | K143071 | Nacera Pearl | EIH Porcelain Powder |
| 28 Apr 2008 | K080195 | NACERA Z AND NACERA Z MEDIUM | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Dental Direkt GmbH (1).
Sources
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 of the most recent filing, which can be a US agent.