# Planmeca USA, Inc.

- Location (FDA's records): Finland, FI
- FDA decisions: 13 (1984–2011): 13 510(k) clearances
- Product codes: EIA (3), KLC (2), EAZ (1), EBA (1), IZH (1), EHD (1), BZG (1), JAC (1), MUE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 2 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Siemens Medical Solution: 1 (https://510kreport.com/company/siemens-medical-solution)

## Firms that cite its devices most
- Planmed OY: 2 (https://510kreport.com/company/planmed)

## Its most-cited devices
- K904953: Planmed Sophie (1991), cited by 1
- K111361: Planmed Nuance Excel (2011), cited by 1

## Recent decisions
- K111361: Planmed Nuance Excel (Sep 23, 2011)
- K081699: Planmeca Sovereign (Aug 29, 2008)
- K923534: PM2002 Proline (Jan 31, 1994)
- K923533: Admark (Mar 4, 1993)
- K923462: Delight (Dec 21, 1992)
- K923461: PM2002 Proline, PM2002 Proline EC (Dec 21, 1992)
- K904953: Planmed Sophie (Apr 18, 1991)
- K904948: PM2002 CC and PM2002 EC (Jan 30, 1991)

Source page: https://510kreport.com/company/planmeca-usa