FDA Registration
Active
🇩🇪 Germany
PRITIDENTA GMBH
Reg #: 3010905160
·
FEI: 3010905160
·
Expires 2026
Products
1
Proprietary Names
19
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- PRITIDENTA GMBH
- Registration Number
- 3010905160
- FEI Number
- 3010905160
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Meisenweg 37
- City
- Leinfelden-Echterdingen Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K161025
Owner / Operator
- Firm Name
- pritidenta GmbH
- Operator Number
- 10047178
- Address
- Meisenweg 37
- City
- Leinfelden-Echterdingen
- State
- DE-NOTA
- Postal Code
- D-70771
- Country
- DE
- Correspondent
- David Figge
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2017-02-07 |
Proprietary Names
pritimultidisc ZrO2 High Translucent
pritimultibloc ZrO2 High Translucent
Tizian Block 5 Multilayer 5YZirconia High Translucent
priti®crown
pritimultidisc ZrO2 Translucent
pritimultidisc ZrO2 Opaque
pritimultidisc ZrO2 Extra Translucent
pritimultibloc ZrO2 Extra Translucent
Tizian Blank 5 Multilayer 4YZirconia Extra Translucent
Tizian Blank 5 White 4YZirconia Extra Translucent
pritimultidisc ZrO2 basic Translucent
Tizian Blank 5 translucent
pritimultidisc ZrO2 Multi Translucent
pritimultidisc ZrO2 multicolor Extra Translucent 95 ZZ System
priti®multidisc ZrO2 Multi Tranlsucent PLUS
GC Initial Zirconia Disk Multilayer Elite
SIN Zirconia Translucent
SIN Zirconia MT Plus
SIN Zirconia Extra Translucent
Establishment Types
Manufacture Medical Device
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device