Not currently registered with FDA under this name
R-Dental Dentalerzeugnisse GmbH
Hamburg, Germany. Named as applicant on 2 dental 510(k) clearances between 2000 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22000–2001
- Markets registered in
- 339 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name R-Dental Dentalerzeugnisse GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | R-Dental Dentalerzeugnisse GmbH | 2 clearances | 2000–2001 | Below |
| European Union | EUDAMED | Manufacturer | R-dental Dentalerzeugnisse GmbH | 35 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | R-dental Dentalerzeugnisse GmbH | 4 | 2002–2017 | 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
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.