# Planmeca Oy

- Location (FDA's records): Helsinki, FI
- FDA decisions: 28 (1993–2023): 28 510(k) clearances
- Product codes: EHD (13), MUH (5), OAS (3), EIA (3), LLZ (3), KLC (1)
- 510(k) review time since 2016: median 187 days, against 107 for FDA's reviews in the same codes and years (1 of 5 faster)
- Predicates its devices cite: 19 (11 its own); citations of its devices by later devices: 30 (11 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
- Anatomage, Inc.: 3 (https://510kreport.com/company/anatomage)
- Trophy: 1 (https://510kreport.com/company/trophy)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)
- Televere Systems: 1 (https://510kreport.com/company/televere-systems)
- Hdx Will Corp.: 1 (https://510kreport.com/company/hdx-will)
- Allengers Medical Systems Limited: 1 (https://510kreport.com/company/allengers-medical-systems)

## Firms that cite its devices most
- Hdx Will Corp.: 3 (https://510kreport.com/company/hdx-will)
- Takara Belmont USA, Inc.: 2 (https://510kreport.com/company/takara-belmont-usa)
- Midmark Corp.: 2 (https://510kreport.com/company/midmark)
- Edlen Imaging, LLC: 1 (https://510kreport.com/company/edlen-imaging)
- Instrumentarium Dental, Palodex Group OY: 1 (https://510kreport.com/company/instrumentarium-dental-palodex-group)
- Overjet, Inc.: 1 (https://510kreport.com/company/overjet)
- Fussen Technology Co., Ltd.: 1 (https://510kreport.com/company/fussen-technology)
- Villa Sistemi Medicali S.P.A.: 1 (https://510kreport.com/company/villa-sistemi-medicali)

## Its most-cited devices
- K060328: Planmeca Promax 3D (2006), cited by 7
- K093590: Planmeca Promax 3D Max (2010), cited by 4
- K011619: Promax, Panoramic X-Ray Unit with Cephalostat (2001), cited by 3
- K160506: Planmeca ProMax 3D Max, Planmeca Maximity (2016), cited by 2
- K970975: Prostyle Intra (1997), cited by 2
- K200572: Planmeca Romexis (2020), cited by 2

## Recent decisions
- K230985: Planmeca Viso (Dec 28, 2023)
- K200572: Planmeca Romexis (Dec 2, 2020)
- K181576: Planmeca Viso (Sep 13, 2018)
- K171385: Planmeca Romexis (Nov 14, 2017)
- K160506: Planmeca ProMax 3D Max, Planmeca Maximity (May 20, 2016)
- K140713: Planmeca Romexis (Jun 16, 2014)
- K103689: Planmeca Promax 3D Mid (Mar 17, 2011)
- K093590: Planmeca Promax 3D Max (May 12, 2010)

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