# K083532: ADX4000-L, DX3000-L

- Pathway: 510(k) (Traditional)
- Applicant: Dexcowin Co., Ltd.
- Decided: Mar 10, 2009 after 102 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: 4 generations back to K000061 (2000). 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)
- K070811: Cordless Portable Dental X-Ray System, Model ADX4000, Dexco (2007) Summary page 1.

## Indications for use
The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.

Source page: https://510kreport.com/device/K083532
Methodology: https://510kreport.com/methodology