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
Phone
603 5702039

Products

Device Name Product Code
Powder, Porcelain EIH

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