# K130163: D-LUX

- Pathway: 510(k) (Traditional)
- Applicant: DiaDent Group International
- Decided: Aug 16, 2013 after 205 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K961735 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042703: Cybird Led Curing Light, Dxm Co., Ltd. (2004) Summary page 1.

## Indications for use
The D-Lux is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 420-490nm waveband of visible light.

Source page: https://510kreport.com/device/K130163
Methodology: https://510kreport.com/methodology