Not currently registered with FDA under this name
Instrumentarium Corp.
Tuusula, Finland. Named as applicant on 6 dental 510(k) clearances between 1991 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61991–2002
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Instrumentarium Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Oct 2002 | K022630 | MODIFICATION TO FOCUS | EHD Extraoral with Timer X-Ray Unit |
| 13 Jul 2000 | K001729 | FOCUS | EHD Extraoral with Timer X-Ray Unit |
| 22 Jun 2000 | K001439 | ORTHOCEPH OC100 D | MUH Digital Extraoral Source X-Ray System |
| 28 Sep 1999 | K992385 | ORTHOPANTOMOGRAPH OP100D | MUH Digital Extraoral Source X-Ray System |
| 27 Apr 1993 | K930338 | ORTHOCEPH OC100 | EHD Extraoral with Timer X-Ray Unit |
| 5 Nov 1991 | K912893 | ORTHOPANTOMOGRAPH 100 | EHD Extraoral with Timer X-Ray Unit |
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.