# K103689: Planmeca Promax 3D Mid

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Mar 17, 2011 after 90 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: 5 generations back to K973598 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 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.
- K093590: Planmeca Promax 3D Max, Planmeca Oy (2010) Summary page 2.

## Indications for use
Planmeca Promax 3D Mid, is a panoramic and cephalometric x-ray unit, which uses Cone Beam Volumetric Tomography (CBVT) to produce three-dimensional images of the human teeth, jaws 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/K103689
Methodology: https://510kreport.com/methodology