bredent medical GmbH & Co. KG
DE-MF-000008125 · Germany · Senden
bredent medical GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 457 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIb | 273 |
|---|---|
| Class IIa | 184 |
Most frequent device types declared: Dental implants, titanium, HELBO Minilaser, abument, titanium, crestal drill, steel, dental implant, zirconia.
Among these devices, 85 are declared sterile, 269 implantable, 128 reusable, 7 active.
Devices declared under this manufacturer
- SKY classic
- blueSKY
- copaSKY
- narrowSKY
Showing 12 of 457 declared devices.
Catalogue references include FD2L16D350, HE100028, SKYPFT01, SKYUCGF2, SKYXST12, bSKY3510.
European nomenclature codes declared: P01020180, L159099, P01020101, Z12011399, Z120615, Q010599.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 457 |
| Country of registration | Germany |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | BREDENT MEDICAL GMBH & CO. KG |
What it holds in Canada
| Licences on record | 18 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 15 |
| Class 3 devices | 3 |
| First licensed | 2018-01-24 |
Licence types: Device Family (11), System (4), Single Device (2), Device Group (1).
Licensed under: SKY SCAN ABUTMENT / SKY SCAN CAP, SURGICAL DRILLS WITH DEPTH STOP, SKY UNI.FIT SCAN BASE S FOR CEREC, COPASKY IMPRESSION ABUTMENT, SKY UNI.CONE IMPRESSION, SKY IMPRESSION ABUTMENTS.
North American profile: Canada only. bredent medical GmbH & Co. KG holds a Canadian licence but was not found in the U.S. register.