Not currently registered with FDA under this name
Ultradent Product, Inc.
South Jordan, UT, United States. Named as applicant on 2 dental 510(k) clearances between 2020 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22020–2023
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Ultradent Product, 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 | Ultradent Product, Inc. | 2 clearances | 2020–2023 | Below |
| South Korea | MFDS | Manufacturer | Ultradent Product, Inc | 1 | 1999–1999 | 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 Product, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Aug 2023 | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | EBC Pit and Fissure Sealant and Conditioner |
| 28 Sep 2020 | K201795 | Transcend | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Ultradent Products, Inc. (2).
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.