# K033147: Cleartooth Digital X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Cleartooth Electronics, Inc.
- Decided: Dec 30, 2003 after 91 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: 1 generation back to K013271 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013271: DXS Digital X-Ray System, Douglas C. Yoon, Dds (2001)

## Indications for use
An extra-oral source x-ray system which is a host PC powered device that produces digital radiographs and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw and supporting oral structures.

Source page: https://510kreport.com/device/K033147
Methodology: https://510kreport.com/methodology