# K080738: Dentron Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Dentron Systems, LLC
- Decided: May 13, 2008 after 57 days
- Product code: EAP (Unit, X-Ray, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.1810
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 8 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.
- K050693: Accent, Air Techniques, Inc. (2005) Summary page 1.
- K990002: Quickray DSX 730, Julie Alliance (1999) Summary page 1.

## Most influential descendants
- K092537: Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 (2009), 2 descendants of its own
- K110886: Clio/Cliosoft (2011), 1 descendant of its own
- K241495: Jazz Classic (2024), 0 descendants of its own

## Indications for use
The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.

Source page: https://510kreport.com/device/K080738
Methodology: https://510kreport.com/methodology
