# K100960: WDS X-Pod and Zen-X Digital X-Ray Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Cefla Dental Group
- Decided: Oct 21, 2010 after 197 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 K990002 (1999). 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)
- K061114: WDS, Size 2 and Size 2, Cefla S.C.R.L. (2006) Summary page 1.

## Indications for use
The WDS X-POD and ZEN-X Sensors are intended to capture intraoiral digital images when exposed to X-Rays. The process is automatic and continues transmitting the digital image to a personal computer by wireless Bluetooth connection or by USB link. Additional legaily marketed components such as conventional X-ray tubes and image capture software that are currently available commercially can be used with the WDS X-POD and ZEN-X Digital X-Ray Sensors.

Source page: https://510kreport.com/device/K100960
Methodology: https://510kreport.com/methodology