Kettenbach GmbH & Co. KG
DE-MF-000005014 · Germany · Eschenburg
Kettenbach GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 101 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 101 |
|---|
Most frequent device types declared: Futar, Identium, Panasil, Profisil Fluoride Varnish Plus, Profisil Free.
Among these devices, 1 are declared sterile, 10 implantable.
Devices declared under this manufacturer
- Futar D Bonus pack
- Futar Normal pack
- Identium Heavy Fast Refill pack
- Identium Heavy Intro pack
- Mucopren Soft
- Profisil
- Profisil Fluoride Varnish Plus Mint Normal pack
- Profisil Free Unflavored Intro pack
- Profisil Free Unflavored Superbulk
- Silginat Normal pack
- Silginat Refill pack
- VSXE One Refill pack
Showing 12 of 101 declared devices.
Catalogue references include 13780, 14713, 14724, 14727, 14823, 14834.
European nomenclature codes declared: Q01020199, Q019008, Q01020104, Q0101010299, Q0101010203, Q01020103.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | KETTENBACH GMBH & CO KG (DE) · FDA 9681356 |
| Devices in EUDAMED | 101 |
| Country of registration | Germany |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | KETTENBACH GMBH & CO. KG |
What it holds in Canada
| Licences on record | 11 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 2 |
| Class 3 devices | 9 |
| First licensed | 2005-06-14 |
Licence types: Device Family (6), Single Device (2), System (1), Device Group (1).
Licensed under: EASY SOFT DENTURE LINER, MUCOPREN SOFT DENTURE LINER, VISALYS TEMP / PL C+B, VISALYS CORE, PL-CORE, VISALYS CEMCORE, VISALYS TOOTH PRIMER.
North American profile: Both markets. Kettenbach GmbH & Co. KG is registered in both the United States and Canada.