# K093590: Planmeca Promax 3D Max

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: May 12, 2010 after 174 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K973598 (1997). 6 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060328: Planmeca Promax 3D, Planmeca Oy (2006) Summary page 2.

## Most influential descendants
- K160140: DENTRIa    series (2016), 9 descendants of its own
- K160506: Planmeca ProMax 3D Max, Planmeca Maximity (2016), 7 descendants of its own
- K181576: Planmeca Viso (2018), 4 descendants of its own
- K230985: Planmeca Viso (2023), 3 descendants of its own
- K251842: Dental Computed Tomography X-ray System (2025), 1 descendant of its own

## Indications for use
Planmeca Promax 3D Max, is a three dimensional Cone Beam Volumetric Tomography (CBVT) x-ray system, which is intended to produce three-dimensional images of the human teeth, jaw and skull. The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. The device is to be operated and used by dentists and other legally qualified health care professionals.

Source page: https://510kreport.com/device/K093590
Methodology: https://510kreport.com/methodology