Manufacturer registered with FDA
Scan4all SAS
LABEGE, France. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 1France
Registered in 3 markets
Where regulators' registries name Scan4all SAS 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 | Scan4all SAS | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Scan4all | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Scan4all SAS | 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 Scan4all SAS currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Color ScannerKZN · Class 2 | — | Maker | WoW | 2019 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | IRIS By StarckWoW | 2019 |
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 |
|---|---|---|
| Scan4allFDA reg. 3015790896 | LABEGE Haute-Garonne, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10061195). 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.