Not currently registered with FDA under this name
Eurodent, Inc.
Canada J4b 5z5, Canada. Named as applicant on 6 dental 510(k) clearances between 1979 and 2005. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61979–2005
- Markets registered in
- 3131 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1976–2026
Registered in 3 markets
Where regulators' registries name Eurodent, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Eurodent, Inc. | 6 clearances | 1979–2005 | Below |
| Colombia | INVIMA | Registration holder | EURODENT LTDA | 130 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | EURODENT SPA | 1 | 2003–2003 | 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
510(k) clearances
Clearances on which FDA names Eurodent, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Nov 2005 | K050571 | ABSOLUTE AMERICA | EIA Operative Dental Unit |
| 21 Dec 1989 | K894058 | ISODENT | EIA Operative Dental Unit |
| 21 Nov 1989 | K894061 | STUDIO UNO | EIA Operative Dental Unit |
| 7 Sep 1989 | K894060 | ESSE QUATTRO/ESSE UNO | KLC Dental Chair with Operative Unit |
| 7 Sep 1989 | K894059 | ISOLIGHT | EAZ Dental Operating Light |
| 27 Feb 1979 | K790078 | BAR & RIDER, SCREWS, TUBES | ECG Boiling Water Sterilizer |
Sources
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 of the most recent filing, which can be a US agent.