# Soredex Palodex Group OY

- Location (FDA's records): Tuusula, FI
- FDA decisions: 9 (2001–2011): 9 510(k) clearances
- Product codes: MUH (5), EHD (3), OAS (1)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 12 (3 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Orion Corporation Soredex: 2 (https://510kreport.com/company/orion-soredex)
- Siemens Corp.: 2 (https://510kreport.com/company/siemens)
- Sirona Dental Systems GmbH: 1 (https://510kreport.com/company/sirona-dental-systems)
- J. Morita USA, Inc.: 1 (https://510kreport.com/company/j-morita-usa)
- Pelton & Crane Co.: 1 (https://510kreport.com/company/pelton-crane)
- Fujifilm Medical System U.S.A., Inc.: 1 (https://510kreport.com/company/fujifilm-medical-system-usa)
- Planmeca Oy: 1 (https://510kreport.com/company/planmeca)
- Imaging Sciences Intl., Inc.: 1 (https://510kreport.com/company/imaging-sciences-intl)

## Firms that cite its devices most
- Instrumentarium Dental, Palodex Group OY: 3 (https://510kreport.com/company/instrumentarium-dental-palodex-group)
- Palodex Group OY: 2 (https://510kreport.com/company/palodex-group)
- Cruxell Corp.: 1 (https://510kreport.com/company/cruxell)
- 3Disc Americas: 1 (https://510kreport.com/company/3disc-americas)
- Carestream Health, Inc.: 1 (https://510kreport.com/company/carestream-health)
- Panoramic Corp.: 1 (https://510kreport.com/company/panoramic)

## Its most-cited devices
- K041050: Digora Optime (or Digora Ontime) (2004), cited by 4
- K110839: Scanora 3D (2011), cited by 2
- K043307: Cranex D (2004), cited by 2
- K073350: Scanora 3D (2007), cited by 2
- K040382: Cranex Basex D or Cranex Excel D (2004), cited by 1
- K063459: Cranex Novus (2006), cited by 1

## Recent decisions
- K110839: Scanora 3D (Jun 30, 2011)
- K073350: Scanora 3D (Dec 19, 2007)
- K070304: Digora PCT/Digipod (Mar 27, 2007)
- K063459: Cranex Novus (Dec 26, 2006)
- K043307: Cranex D (Dec 17, 2004)
- K040382: Cranex Basex D or Cranex Excel D (Jul 13, 2004)
- K041050: Digora Optime (or Digora Ontime) (Jun 15, 2004)
- K033755: Minray (Apr 29, 2004)

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