Not currently registered with FDA under this name
Instrumentarium Dental, Palodex Group OY
Tuusula, Finland. Named as applicant on 5 dental 510(k) clearances between 2007 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 52007–2014
- Markets registered in
- 743 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Instrumentarium Dental, 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 | Instrumentarium Dental, Palodex Group OY | 5 clearances | 2007–2014 | Below |
| South Korea | MFDS | Manufacturer | Instrumentarium Dental, PaloDEx Group OyInstrumentarium Dental, PaloDEx Group OY · Instrumentarium Dental, PaloDEx Group OY (핀란드) | 15 | 1998–2015 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Instrumentarium Dental, PaloDEx Group OyInstrumentarium Dental PaloDEx group oy | 10 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INSTRUMENTARIUM DENTAL, PALODEX GROUP OY | 7 | 2005–2015 | Pure Global AI |
| Australia | TGA | Manufacturer | Instrumentarium Dental PaloDex Group Oy | 4 | 2013–2021 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | INSTRUMENTARIUM DENTAL, PALODEX GROUP OY | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Instrumentarium dental PaloDEx Group Oy | 3 | — | 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 Instrumentarium Dental, Palodex Group OY as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Mar 2014 | K133231 | DIGORA OPTIME | MUH Digital Extraoral Source X-Ray System |
| 6 Oct 2010 | K093683 | ORTHOPANTOMOGRAPH OP300 | MUH Digital Extraoral Source X-Ray System |
| 20 Nov 2009 | K092591 | ORTHOPANTOMOGRAPH OP30 | MUH Digital Extraoral Source X-Ray System |
| 2 Sep 2008 | K081925 | SNAPSHOT | MUH Digital Extraoral Source X-Ray System |
| 2 Jul 2007 | K063837 | SIGMA M | MUH Digital Extraoral Source X-Ray System |
Some of these clearances are listed with FDA today by another company: PaloDEx Group Oy (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.