Not currently registered with FDA under this name
Ultradent Products Inc. / Oratech, LLC
Salt Lake City, UT, United States. Named as applicant on 2 dental 510(k) clearances between 2013 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22013–2013
- Markets registered in
- 344 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Ultradent Products Inc. / Oratech, LLC 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 | Ultradent Products Inc. / Oratech, LLC | 2 clearances | 2013–2013 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | Ultradent Products Inc. / Ora tech LLC | 43 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Ultradent Products Inc / OraTech LLC | 1 | 2023–2023 | 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 Ultradent Products Inc. / Oratech, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Nov 2013 | K132109 | ENAMELAST | LBH Cavity Varnish |
| 24 Oct 2013 | K132255 | ULTRACEM | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Ultradent Products, Inc. (2), Solventum US LLC (1), Colgate-Palmolive Company (1), NuSmile, Ltd. (1).
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.