Manufacturer registered with FDA
White Smile GmbH
Birkenau, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 756 registrations outside the US
- Establishments
- 1Germany
Registered in 7 markets
Where regulators' registries name White Smile GmbH 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 | White Smile GmbH | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | WHITEsmile GmbH | 40 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | WHITESmile GmbHWHITEsmile GmbH | 6 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | WHITESMILE GMBH | 4 | 2013–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Whitesmile Gmbh | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | WHITEsmile GmbH | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | WHITEsmile GmbH | 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
Devices listed with FDA
What White Smile GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | flash Whitening Lamp | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| WHITEsmile GMBHFDA reg. 3014545089 | Birkenau Hesse, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057594). 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.