bredent GmbH & Co. KG
DE-MF-000008124 · Germany · Senden
bredent GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 2 701 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 2 701 |
|---|
Most frequent device types declared: brush resin, denture resin, PMMA, denture tooth, PMMA, light-curing opaquer, light-curing veneering system.
Among these devices, 909 are declared implantable.
Catalogue references include 54000133, 540PI030, MCA35120, TO2G3D40, TOWL2D20, TUWL2A10.
European nomenclature codes declared: Q01020601, Q01020502, Q010699, Q0102050199, Q0102050101, Q010280.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | BREDENT GMBH & CO.KG (DE) · FDA 1000303432 |
| Devices in EUDAMED | 2 701 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BREDENT GMBH & CO. KG |
What it holds in Canada
| Licences on record | 22 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 17 |
| Class 3 devices | 5 |
| First licensed | 1999-03-26 |
Licence types: Device Family (15), System (4), Device Group Family (3).
Licensed under: DENTAPLAST, FGP FRICTION FIT SYSTEM, VARIO KUGEL SNAP VKS-OC/SG VARIO SOFT MATRICES, VARIO KUGEL SNAP VKS-OC/SG VARIO SOFT MATRICES, VKS-OC TITANIUM, STUD-HEAD SCREW, VARIO KUGEL SNAP VKS-OC/RS TITANIUM MATRIX HOU.
North American profile: Both markets. bredent GmbH & Co. KG is registered in both the United States and Canada.