Data / Medical devices / France / Itena Clinical Villepinte
Itena Clinical Villepinte: FDA-registered device maker in Villepinte Seine-Saint-Denis, France, 9 510(k) clearances
Itena Clinical Villepinte is registered with the FDA (registration 3013557697) in Villepinte Seine-Saint-Denis, France. It lists 12 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 31, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013557697
- Address
- 97 Allee de la Louve, Villepinte Seine-Saint-Denis, France, 93420
- Owner or operator
- ITENA Clinical (10045822)
- Roles
- Foreign private label distributor, Specification developer
- First device listed
- December 31, 2013
- Registered through
- 2026
- Brand names listed
- AGENT, TOOTH BONDING, RESIN, APPLICATOR, RESIN, CEMENT, DENTAL, DISK, ABRASIVE, DRILL, DENTAL, INTRAORAL, EBC / SEALANT, PIT AND FISSURE, AND CONDITIONER, HANDLE, INSTRUMENT, DENTAL, Material, tooth shade, resin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Specification developer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Specification developer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Specification developer | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Foreign private label distributor | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Specification developer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Specification developer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Foreign private label distributor | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Specification developer | accessdata.fda.gov |
| Resin, Root Canal Filling | KIF | 2 | Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Specification developer | accessdata.fda.gov |
| Wheel, Polishing Agent | EJQ | 1 | Foreign private label distributor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2017 | K170207 | Obturys | KIF | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| March 14, 2017 | K162960 | TotalC-Ram | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| June 14, 2013 | K122551 | PROVITEMP | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| June 11, 2013 | K122521 | PREVENT SEAL | EBC | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| April 26, 2013 | K122549 | DENTO TEMP | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| April 19, 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | EMA | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| March 19, 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | KLE | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| March 5, 2013 | K121769 | DENTOCORE / DENTOCORE BODY | EBF | Substantially Equivalent | Itena Clinical | accessdata.fda.gov |
| February 14, 1990 | K896659 | SILANE | KLE | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Dental
- All makers of Agent, Tooth Bonding, Resin
- All makers of Handle, Instrument, Dental
- All makers of Material, Tooth Shade, Resin
- All makers of Resin, Root Canal Filling
- All makers of Sealant, Pit And Fissure, And Conditioner
Updated July 31, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.