# K092103: Dental Extraoral Source X-Ray System (Esx)

- Pathway: 510(k) (Traditional)
- Applicant: VATECH Co., Ltd.
- Decided: Oct 9, 2009 after 87 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
Longest line of descent: 1 generation back to K000672 (2000). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000672: Heliodent Vario, Sirona Dental Systems GmbH (2000) Summary page 1.

## Most influential descendants
- K123493: Vex-S 100W Intraoral X-Ray System (2012), 3 descendants of its own
- K163705: EzRay Air W (2017), 2 descendants of its own
- K223058: EzRay Air 2 Wall (Model: VEX-S350W) (2022), 1 descendant of its own
- K250839: Dental X-ray System (2026), 0 descendants of its own

## Indications for use
The ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.

Source page: https://510kreport.com/device/K092103
Methodology: https://510kreport.com/methodology