Data / Medical devices / Germany / Pritidenta GMBH
Pritidenta GMBH: FDA-registered device maker in Leinfelden-Echterdingen Baden-Wurttemberg, Germany, 3 510(k) clearances
Pritidenta GMBH is registered with the FDA (registration 3010905160) in Leinfelden-Echterdingen Baden-Wurttemberg, Germany. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated February 3, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010905160
- Address
- Meisenweg 37, Leinfelden-Echterdingen Baden-Wurttemberg, Germany, D-70771
- Owner or operator
- pritidenta GmbH (10047178)
- Roles
- Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- July 11, 2014
- Registered through
- 2027
- Brand names listed
- GC Initial Zirconia Disk Multilayer Elite, SIN Zirconia Extra Translucent, SIN Zirconia MT Plus, SIN Zirconia Translucent, Tizian Blank 5 Multilayer 4YZirconia Extra Translucent, Tizian Blank 5 White 4YZirconia Extra Translucent, Tizian Blank 5 translucent, Tizian Block 5 Multilayer 5YZirconia High Translucent and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 3, 2017 | K161025 | priti multidisc ZrO2 High Translucent | EIH | Substantially Equivalent | Pritidenta GmbH | accessdata.fda.gov |
| August 11, 2010 | K102128 | VITABLOCS | EIH | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH & Co. | accessdata.fda.gov |
| April 8, 2010 | K100250 | XCERAM | EIH | Substantially Equivalent | Xceramusa | accessdata.fda.gov |
Compare with other makers
Updated February 3, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.