# K122582: Dental X-Ray Z70 (W); Dental X-Ray Z70 (M); Dental X-Ray Z70 (C)

- Pathway: 510(k) (Traditional)
- Applicant: Denterprise International, Inc.
- Decided: Dec 7, 2012 after 106 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160458: BI Image-X Evolution (2016), 0 descendants of its own

## Indications for use
The device is an X-Ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.

Source page: https://510kreport.com/device/K122582
Methodology: https://510kreport.com/methodology