Manufacturer registered with FDA
pritidenta GmbH
Leinfelden-Echterdingen, Germany. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 19
- 510(k) clearances
- 12017–2017
- Markets registered in
- 810 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 2007–2026
Registered in 8 markets
Where regulators' registries name pritidenta 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 | pritidenta GmbH | 1 clearances | 2017–2017 | Below |
| Brazil | ANVISA | Manufacturer | PRITIDENTA GMBH | 3 | 2023–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | pritidenta GmbH | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | pritidenta GmbH | 1 | 2025–2025 | Pure Global AI |
| Canada | Health Canada | Registration holder | PRITIDENTA B.V. | 1 | 2013–2013 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | pritidenta® GmbH | 1 | 2023–2023 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | pritidenta GmbH | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | pritidenta GmbH | 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 pritidenta 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | GC Initial Zirconia Disk Multilayer Elitepriti®crownpriti®multidisc ZrO2 Multi Tranlsucent PLUSpritimultibloc ZrO2 Extra Translucentpritimultibloc ZrO2 High Translucentpritimultidisc ZrO2 basic Translucentpritimultidisc ZrO2 Extra Translucentpritimultidisc ZrO2 High Translucentpritimultidisc ZrO2 Multi Translucentpritimultidisc ZrO2 multicolor Extra Translucent 95 ZZ System 9 morepritimultidisc ZrO2 Opaquepritimultidisc ZrO2 TranslucentSIN Zirconia Extra TranslucentSIN Zirconia MT PlusSIN Zirconia TranslucentTizian Blank 5 Multilayer 4YZirconia Extra TranslucentTizian Blank 5 translucentTizian Blank 5 White 4YZirconia Extra TranslucentTizian Block 5 Multilayer 5YZirconia High Translucent | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names pritidenta GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 3 Feb 2017 | K161025 | priti multidisc ZrO2 High Translucent | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: GC America Inc. (1).
Also lists devices cleared under other names
pritidenta GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Vita Zahnfabrik H. Rauter GmbH & Co. Kg. (1), Xceramusa (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PRITIDENTA GMBHFDA reg. 3010905160 | Leinfelden-Echterdingen Baden-Wurttemberg, Germany | Foreign exporter, Manufacturer, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047178). 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.