Not currently registered with FDA under this name
Sopro - Acteon Group
Laciotat, France. Named as applicant on 3 dental 510(k) clearances between 2014 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32014–2015
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Sopro - Acteon Group 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 | Sopro - Acteon Group | 3 clearances | 2014–2015 | Below |
| Brazil | ANVISA | Manufacturer | SOPRO ACTEON GROUP | 2 | 2008–2008 | 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 Sopro - Acteon Group as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Aug 2015 | K142995 | SOPIX | MUH Digital Extraoral Source X-Ray System |
| 31 Jul 2015 | K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner | MUH Digital Extraoral Source X-Ray System |
| 5 Sep 2014 | K140013 | SOPIX INSIDE, SOPIX2 INSIDE | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Satelec - Acteon Group (3).
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.