dentona AG
DE-MF-000005550 · Germany · Dortmund
dentona AG 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 |
|---|
Devices declared under this manufacturer
- dentona flexisplint
- dentona vivapink
- dentona vivatemp
- optimill memopink
- optimill memosplint
- optimill memosplint Version S
- optiprint I-B-T 385
- optiprint durotec
- optiprint guide 385
- optiprint guide 405
- optiprint laviva
- optiprint lumina
Showing 12 of 101 declared devices.
Catalogue references include 42269, 48100, 48268, 48284, 48289, 48300.
European nomenclature codes declared: Q010699.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | DENTONA AG (DE) · FDA 3009815428 |
| Devices in EUDAMED | 101 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 101 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. dentona AG is registered in the United States but was not found in the Canadian register.