Not currently registered with FDA under this name
Planmeca USA, Inc.
Finland, Finland. Named as applicant on 8 dental 510(k) clearances between 1984 and 2008. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 81984–2008
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1980–2026
510(k) clearances
Clearances on which FDA names Planmeca USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Aug 2008 | K081699 | PLANMECA SOVEREIGN | EIA Operative Dental Unit |
| 31 Jan 1994 | K923534 | PM2002 PROLINE | KLC Dental Chair with Operative Unit |
| 21 Dec 1992 | K923462 | DELIGHT | EAZ Dental Operating Light |
| 21 Dec 1992 | K923461 | PM2002 PROLINE, PM2002 PROLINE EC | KLC Dental Chair with Operative Unit |
| 30 Jan 1991 | K904948 | PM2002 CC AND PM2002 EC | EIA Operative Dental Unit |
| 26 Nov 1986 | K864474 | DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC | EHD Extraoral with Timer X-Ray Unit |
| 12 Sep 1984 | K842357 | PM 2000 DENTAL UNIT | EIA Operative Dental Unit |
| 31 Jul 1984 | K842358 | ISOLIGHT | EBA Surgical Headlight Light |
Some of these clearances are listed with FDA today by another company: Planmeca 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.