# K072244: Planmeca Proone

- Pathway: 510(k) (Traditional)
- Applicant: Planmeca Oy
- Decided: Sep 21, 2007 after 39 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: 2 generations back to K000163 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000454: DIMEX 2, Planmeca Oy (2000) Summary page 2.
- K051464: Planmeca Promax with Dec (Dynamic Exposure Control), Planmeca Oy (2005) Summary page 2.

## Indications for use
Planmeca ProOne, dental panoramic x-ray imaging system, is an extraoral source x-ray system, which is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The device is digital, and the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer. The device is to be operated and used by dentists and other legally qualified professionals.

Source page: https://510kreport.com/device/K072244
Methodology: https://510kreport.com/methodology