# K190234: ODI HD Dental Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Cnd Global Technologies, Inc.
- Decided: Mar 1, 2019 after 23 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: 7 generations back to K933455 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163282: Apex Dental Sensors, Masterlink, LLC (2017) Summary page 4.

## Indications for use
ODI HD Dental Sensor is intended to be used by dentists and other qualified professionals for providing diagnostic x-ray radiographs of dentition, jaws and other oral structures.

Source page: https://510kreport.com/device/K190234
Methodology: https://510kreport.com/methodology
