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Sign in to claim this brandITENA CLINICAL
France·FR-MF-000011957
Last updated May 31, 2026
What ITENA CLINICAL makes
The company produces dental composite resins, preformed root canal posts, and dentine bonding agents for adhesive procedures. It also supplies endodontic filling and sealing materials, dental restoration retention pin kits, and single-use application tools. Hygroscopic dental cements and dental prosthesis priming agents are part of its portfolio, alongside multiple variants of a glass-fibre post system and a universal adhesive system for dentistry.
These products are classified under EU Medical Device Regulations as Class I or Class II/IIa devices, with some authorised via the FDA’s 510(k) pathway and listed in the FDA’s UDI system. They are registered in the EU’s eudamed database, reflecting compliance with European and U.S. regulatory requirements. The manufacturer is based in France.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
Where is ITENA CLINICAL based?
ITENA CLINICAL is based in France. This information is provided directly by the manufacturer's registry data, which identifies the country of origin as FR.
What types of medical devices does ITENA CLINICAL manufacture?
The company produces a range of dental products, primarily focusing on dental composite resins, preformed root canal posts, and dentine bonding agents. Their portfolio also includes endodontic filling and sealing materials, dental restoration retention pin kits, single-use application tools, hygroscopic dental cements, and dental prosthesis priming agents.
How are the devices from ITENA CLINICAL classified?
The devices are classified as Class I, Class II, or Class IIa. These classifications are determined by the EU Medical Device Regulations, which categorize products based on their intended use and risk profile.
Which regulatory registries list ITENA CLINICAL devices?
Devices from ITENA CLINICAL are listed in the EUDAMED database, the FDA 510(k) pathway, and the FDA UDI system. These listings indicate that the individual devices have met the necessary regulatory requirements for their respective markets in the European Union and the United States.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- France
- Address
- 188, Avenue Victor Hugo, Paris, France
- Website
- itena-clinical.com
- —
- —
- [email protected]
- Phone
- +330764852012
- PRRC Contact
- Alexandra PETIT
- EUDAMED SRN
- FR-MF-000011957
- FDA FEI Number
- —
- DUNS Number
- 278261221
Catalogue (96)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Mta Biorep | Coffret MTA BIOREP 5 patients | FDA UDI | Class II | Active |
| Reflectys Flow | A3 | FDA UDI | Class II | Active |
| Reflectys | A1 CP | FDA UDI | Class II | Active |
| Dentocem | DCA-2.5 | FDA UDI | Class II | Active |
| Coffret DENTOCLIC Fibre de verre | Coffret Ivoire | FDA UDI | Class I | Active |
| Reflectys | A2O CP | FDA UDI | Class II | Active |
| Reflectys | B1 CP | FDA UDI | Class II | Active |
| Provitemp | Automix syringe | FDA UDI | Class II | Active |
| Reflectys | B2 CP | FDA UDI | Class II | Active |
| Total C-Ram | OPAQUE | FDA UDI | Class II | Active |
| Reflectys | B1 | FDA UDI | Class II | Active |
| Obturys | Automix | FDA UDI | Class II | Active |
| Mta Bioseal | Coffret MTA BIOSEAL | FDA UDI | Class II | Active |
| Dentocore Body | Automix | EUDAMEDFDA UDI | Class II | Active |
| Reflectys | B3 CP | FDA UDI | Class II | Active |
| Dentocore | Cartridge white shade | EUDAMEDFDA UDI | Class II | Active |
| Reflectys Flow | B2 | FDA UDI | Class II | Active |
| Reflectys | A4 CP | FDA UDI | Class II | Active |
| Reflectys | E CP | FDA UDI | Class II | Active |
| Dentotemp | automix | EUDAMEDFDA UDI | Class II | Active |
| Quickbond | BOND | FDA UDI | Class II | Active |
| Iperbond Ultra | IPBDUL-5 | FDA UDI | Class II | Unknown |
| Silanea | SILSER1.2-5 | FDA UDI | Class II | Unknown |
| Quickbond | PRIME | FDA UDI | Class II | Active |
| Totalcem | A2 | FDA UDI | Class II | Active |
| DENTOCLIC Tenons Fibre de verre | Recharge tenon ivoire jaune | FDA UDI | Class I | Active |
| Reflectys | C2 | FDA UDI | Class II | Active |
| Reflectys | A30 | FDA UDI | Class II | Active |
| Dentocrown | A1B1 | FDA UDI | Class II | Unknown |
| Reflectys | A20 | FDA UDI | Class II | Active |
| Reflectys | A4 | FDA UDI | Class II | Active |
| DENTOCLIC Tenons Fibre de verre | Recharge tenon translucide blanc | FDA UDI | Class I | Active |
| Dentocore / Dentocore Body | K121769 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Dentoetch Quickbond Bond Activator | K122522 | FDA 510(k) | Class II | Active |
| Obturys | K170207 | FDA 510(k) | Class II | Active |
| Prevent Seal | K122521 | EUDAMEDFDA 510(k) | Class II | Active |
| Provitemp, Dentotemp, Totalcem, Dentocem | K121804 | FDA 510(k) | Class II | Active |
| Provitemp | K122551 | FDA 510(k) | Class II | Active |
| Dento Temp | K122549 | FDA 510(k) | Class II | Active |
| TotalC-Ram | K162960 | FDA 510(k) | Class II | Active |
| Totalcem | TTLCEM-A2 | EUDAMEDFDA UDI | Class IIa | Active |
| Dentoclic | CAT.EN C - 01/29 | EUDAMED | Class I | Active |
| Totalcem | TCEM3-VPTR | EUDAMED | Class IIa | Active |
| Totalcem | TTLCEM-TR | EUDAMEDFDA UDI | Class IIa | Active |
| Dentoclic | CAT.EN C - 01/25 | EUDAMED | Class IIa | Active |
| Aireo V-Lock System | AIRU200-A | EUDAMED | Class I | Active |
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