Manufacturer registered with FDA
ITENA Clinical
Villepinte, France. Lists 12 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 12
- Brands and models
- 12
- 510(k) clearances
- 82013–2017
- Markets registered in
- 10263 registrations outside the US
- Establishments
- 1France
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name ITENA Clinical as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | ITENA Clinical | 8 clearances | 2013–2017 | Below |
| European Union | EUDAMED | Registration holder | ITENA CLINICALItena Clinical | 187 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | ITENA CLINICAL | 25 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Itena Clinical | 14 | 2012–2019 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | ITENA CLINICAL | 13 | 2025–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ITENA CLINICAL | 11 | 2008–2022 | Pure Global AI |
| Canada | Health Canada | Registration holder | ITENA CLINICAL | 7 | 2013–2013 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | ITENA CLINICAL | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 法国依蒂娜ITENA CLINICAL | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | ITENA CLINICAL | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What ITENA Clinical currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | CEMENT, DENTAL | 2014 |
| Root Canal Filling ResinKIF · Class 2 | Root canal filling materials | Maker | RESIN, ROOT CANAL FILLING | 2017 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Material, tooth shade, resin | 2013 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | AGENT, TOOTH BONDING, RESIN | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | DRILL, DENTAL, INTRAORAL | 2014 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | EBC / SEALANT, PIT AND FISSURE, AND CONDITIONER | 2014 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | DISK, ABRASIVE | 2016 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | POINT, ABRASIVE | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | HANDLE, INSTRUMENT, DENTAL | 2014 |
| Polishing Agent WheelEJQ · Class 1 | Polishing & prophylaxis | Lister | WHEEL, POLISHING AGENT | 2016 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | ROOT CANAL | 2014 |
| Resin ApplicatorKXR · Class 1 | — | Maker | APPLICATOR, RESIN | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names ITENA Clinical as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Jul 2017 | K170207 | Obturys | KIF Root Canal Filling Resin |
| 14 Mar 2017 | K162960 | TotalC-Ram | EMA Dental Cement |
| 14 Jun 2013 | K122551 | PROVITEMP | EMA Dental Cement |
| 11 Jun 2013 | K122521 | PREVENT SEAL | EBC Pit and Fissure Sealant and Conditioner |
| 26 Apr 2013 | K122549 | DENTO TEMP | EMA Dental Cement |
| 19 Apr 2013 | K121804 | PROVITEMP, DENTOTEMP, TOTALCEM, DENTOCEM | EMA Dental Cement |
| 19 Mar 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | KLE Resin Tooth Bonding Agent |
| 5 Mar 2013 | K121769 | DENTOCORE / DENTOCORE BODY | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: B.J.M. Laboratories Ltd (2).
Also lists devices cleared under other names
ITENA Clinical lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Pulpdent Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 14 Feb 1990 | K896659 | SILANE | Pulpdent Corporation | KLE Resin Tooth Bonding Agent |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Itena Clinical VillepinteFDA reg. 3013557697 | Villepinte Seine-Saint-Denis, France | Private-label distributor, Specification developer |
Other names on FDA records
Itena Clinical Villepinte
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10045822). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.