ITENA CLINICAL
FR-MF-000011957 · France · Paris
ITENA CLINICAL is registered in the European database on medical devices as a manufacturer, with 214 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
| Class IIa | 209 |
|---|---|
| Class IIb | 5 |
Among these devices, 103 are declared implantable, 49 reusable.
Devices declared under this manufacturer
- AIREO V-LOCK SYSTEM
- AIREO V-LOCK SYSTEM
- DENTOCLIC Glass Fiber posts
- DENTOCORE BODY
- DENTOTEMP
- Dentoclic
- MTA BIOREP
- MTA Bioseal
- NUMERYS HC
- Numerys GF
- PREVENT SEAL
- Reflectys
Showing 12 of 214 declared devices.
Catalogue references include DCAR100115, DTCA2-20, FL2-32, FPFA-1.2, FVOR5-1.4, PVSEAL.
European nomenclature codes declared: Q010199, Q01010103, Q01010299, Q019005, Q010299, Q0101010299.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 214 |
| Country of registration | France |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Device-level evidence
| Devices with a numeric GTIN | 214 |
|---|---|
| Found in the U.S. device database | 63 |
| Share | 29.4 % |
⚠ The two levels disagree here. This company’s name was not found in the FDA establishment register, yet some of its devices are in the U.S. device database. The likeliest reading is that the name match failed.
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | ITENA CLINICAL |
North American profile: Canada only. ITENA CLINICAL holds a Canadian licence but was not found in the U.S. register.