Not currently registered with FDA under this name
Novodent SA
Yverdons-Les-Bains, Switzerland. Named as applicant on 2 dental 510(k) clearances between 2018 and 2020. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22018–2020
- Markets registered in
- 71,262 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 7 markets
Where regulators' registries name Novodent SA 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 | Novodent SA | 2 clearances | 2018–2020 | Below |
| European Union | EUDAMED | Registration holder | Novodent SANOVODENT SA | 1,221 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | NOVODENT SA | 33 | — | Pure Global AI |
| Egypt | EDA | Manufacturer | Novodent SA, | 4 | 2023–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Novodent SA | 2 | 2019–2020 | Pure Global AI |
| Israel | AMAR | Manufacturer | NOVODENT SA | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Novodent SA | 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
510(k) clearances
Clearances on which FDA names Novodent SA as the applicant.
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.