# K220826: LED Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Foshan Coxo Medical Instrument Co., Ltd.
- Decided: Dec 8, 2022 after 261 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: 4 generations back to K091020 (2009). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200809: D-LUX+, DiaDent Group International (2020) Summary page 6.

## Most influential descendants
- K243921: LED Curing Lights (DB686 HALO) (2025), 0 descendants of its own
- K232076: Fibercure (2023), 0 descendants of its own

## Indications for use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Source page: https://510kreport.com/device/K220826
Methodology: https://510kreport.com/methodology