Dentsply DeTrey GmbH
DE-MF-000005905 · Germany · Konstanz
Dentsply DeTrey GmbH is registered in the European database on medical devices as a manufacturer, with 8 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 8 |
|---|
Among these devices, 7 are declared implantable.
Devices declared under this manufacturer
- AH PLUS JET STARTER KIT
- AH PLUS JET SYRINGE REFILL
- AH PLUS NEO TUBES
- AH PLUS TUBES
- AH Plus
- AH Plus Jet Refill
- AH Plus Jet Starter Kit
- ChemVarnish
Catalogue references include 60607050, 60620110, 60620110N, 60620112N, 60620115, 60620115N.
European nomenclature codes declared: Q01010202, Q0101010299.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DENTSPLY DETREY GmbH (DE) · FDA 8010638 |
| Devices in EUDAMED | 8 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DENTSPLY DETREY GMBH |
What it holds in Canada
| Licences on record | 14 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 3 devices | 13 |
| First licensed | 1999-03-31 |
Licence types: Device Family (5), Device Group Family (4), Single Device (3), System (2).
Licensed under: DYRACT FLOW, POLY-F PLUS (POLYCARBOXYLATE CEMENT), AH 26 (ROOT CANAL FILLING MATERIAL), AH PLUS ROOT CANAL SEALER, QUIXFIL POSTERIOR RESTORATIVE, DYRACT EXTRA UNIVERSAL COMPOMER RESTORATIVE.
North American profile: Both markets. Dentsply DeTrey GmbH is registered in both the United States and Canada.