Not currently registered with FDA under this name
Soredex Palodex Group OY
Tuusula, Finland. Named as applicant on 9 dental 510(k) clearances between 2001 and 2011. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 92001–2011
- Markets registered in
- 738 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Soredex Palodex Group OY 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 | Soredex Palodex Group OY | 9 clearances | 2001–2011 | Below |
| South Korea | MFDS | Manufacturer | Soredex, PaloDex Group OySoredex, PaloDEx Group Oy · SOREDEX, PALODEX GROUP OY · +2 | 15 | 2000–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SOREDEX, PALODEX GROUP OY | 11 | 2006–2014 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SOREDEX, PaloDEx Group Oy | 7 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SOREDEX, Palodex Group Oy | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Soredex PaloDex Group OySoredex, Palodex Group Oy | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Soredex PaloDEx Group Oy | 1 | 2021–2021 | 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 Soredex Palodex Group OY as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jun 2011 | K110839 | SCANORA 3D | OAS Dental Computed Tomography X-Ray |
| 19 Dec 2007 | K073350 | SCANORA 3D | MUH Digital Extraoral Source X-Ray System |
| 27 Mar 2007 | K070304 | DIGORA PCT/DIGIPOD | MUH Digital Extraoral Source X-Ray System |
| 26 Dec 2006 | K063459 | CRANEX NOVUS | MUH Digital Extraoral Source X-Ray System |
| 17 Dec 2004 | K043307 | CRANEX D | EHD Extraoral with Timer X-Ray Unit |
| 13 Jul 2004 | K040382 | CRANEX BASEX D OR CRANEX EXCEL D | EHD Extraoral with Timer X-Ray Unit |
| 15 Jun 2004 | K041050 | DIGORA OPTIME (OR DIGORA ONTIME) | MUH Digital Extraoral Source X-Ray System |
| 29 Apr 2004 | K033755 | MINRAY | EHD Extraoral with Timer X-Ray Unit |
| 10 Aug 2001 | K012170 | DIGORA PCT | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: Satelec - Acteon Group (1).
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.