# Palodex Group OY

- Location (FDA's records): Tuusula, FI
- FDA decisions: 10 (2012–2024): 10 510(k) clearances
- Product codes: OAS (8), MUH (1), LLZ (1)
- 510(k) review time since 2016: median 105 days, against 107 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 15 (7 its own); citations of its devices by later devices: 11 (7 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Instrumentarium Dental, Palodex Group OY: 2 (https://510kreport.com/company/instrumentarium-dental-palodex-group)
- Soredex Palodex Group OY: 2 (https://510kreport.com/company/soredex-palodex-group)
- Rayence Co., Ltd.: 1 (https://510kreport.com/company/rayence)
- Imaging Sciences International (Dba Gendex, LLC): 1 (https://510kreport.com/company/imaging-sciences-international-dba-gendex)
- Imaging Sciences International: 1 (https://510kreport.com/company/imaging-sciences-international)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)

## Firms that cite its devices most
- Nobel Biocare AB: 2 (https://510kreport.com/company/nobel-biocare)
- De Gotzen S.R.L.: 1 (https://510kreport.com/company/de-gotzen)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)

## Its most-cited devices
- K133544: OP300 (2014), cited by 4
- K162799: Cliniview (2017), cited by 3
- K122018: OP300 (2012), cited by 1
- K180947: Orthopantomograph OP 3D (2018), cited by 1
- K230505: Orthopantomograph™ OP 3D LX (2023), cited by 1
- K163423: Orthopantomograph OP300 (2017), cited by 1

## Recent decisions
- K241249: Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) (Sep 12, 2024)
- K230505: Orthopantomograph™ OP 3D LX (Jun 9, 2023)
- K180947: Orthopantomograph OP 3D (Jun 7, 2018)
- K173646: FS Ergo (Dec 19, 2017)
- K163423: Orthopantomograph OP300 (Aug 31, 2017)
- K162799: Cliniview (Apr 25, 2017)
- K170813: Orthopantomograph OP 3D (Apr 7, 2017)
- K133544: OP300 (Mar 26, 2014)

Source page: https://510kreport.com/company/palodex-group