DeguDent GmbH
DE-MF-000007937 · Germany · Hanau - Wolfgang
DeguDent GmbH is registered in the European database on medical devices as a manufacturer, with 149 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 149 |
|---|
Among these devices, 147 are declared implantable.
Devices declared under this manufacturer
- CELTRA Duo LT C2, C14, 4PCS
- CELTRA PRESS HT i1, 3x6g
- CELTRA PRESS HT i1, 5x3g
- CELTRA PRESS HT i3, 3x6g
- CELTRA PRESS LT A3, 3x6g
- CELTRA PRESS MO 1, 3x6g
- CEREC Tessera Abutment LT A1 A16 S 3 PCS
- CEREC Tessera Abutment LT A2 A16 S 3 PCS
- CEREC Tessera Abutment LT B2 A14 L 3 PCS
- CEREC Tessera, HT, B1, C14, 4PC
- CEREC Tessera, MT, A3, C14, 4PC
- CEREC Tessera, MT, B3, C14, 4PC
Showing 12 of 149 declared devices.
Catalogue references include 5365400416, 5365400546, 5365431255, 5365431525, 5365432005, 5365432015.
European nomenclature codes declared: Q010699, Q010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DEGUDENT GMBH (DE) · FDA 9681199 |
| Devices in EUDAMED | 149 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DEGUDENT GMBH |
What it holds in Canada
| Licences on record | 17 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 17 |
| First licensed | 1999-06-03 |
Licence types: Device Family (15), System (2).
Licensed under: COBALT CHROMIUM BASE METAL ALLOYS, LFC, CERCON SMART CERAMICS BASE, DUCERAGOLD KISS PRECIOUS METAL PORCELAIN, DUCERAM KISS BONDING PORCELAIN, COBALT-BASED ALLOYS.
North American profile: Both markets. DeguDent GmbH is registered in both the United States and Canada.