# K223142: Coltolux Comfort LED Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Dent4you AG
- Decided: Dec 22, 2022 after 79 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: 1 generation back to K040551 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040551: Coltolux Led Curing Light, Coltene/Whaledent, Inc. (2004) Summary page 4.

## Indications for use
The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.

Source page: https://510kreport.com/device/K223142
Methodology: https://510kreport.com/methodology