# K251206: Digital X-Ray DentiMax Pro Imaging System

- Pathway: 510(k) (Traditional)
- Applicant: Dentimax, Inc.
- Decided: Sep 24, 2025 after 159 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 K050693 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092547: Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box, Dentimax (2009) Summary page 7.

## Indications for use
The Digital X-Ray DentiMax Pro Imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photons and convert them into dental images that may be stored, viewed, and manipulated by dentists for the diagnosis of disease of the teeth, jaw, and oral structures.

Source page: https://510kreport.com/device/K251206
Methodology: https://510kreport.com/methodology