# K040551: Coltolux Led Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent, Inc.
- Decided: Mar 15, 2004 after 13 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
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K121093: D1 Led Curing Light, Spec 3, Dentronix Led 3000 (2012), 3 descendants of its own
- K173876: Cybird LED Curing Light (2018), 1 descendant of its own
- K153514: Premium Plus C01/C02 LED Curing Light (2016), 1 descendant of its own
- K250009: LED Curing Light (C01-X, C02-X) (2025), 0 descendants of its own
- K223142: Coltolux Comfort LED Curing Light (2022), 0 descendants of its own

## Indications for use
This device is indicated for the polymerization of intra oral and extra oral 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 photo initiator.

Source page: https://510kreport.com/device/K040551
Methodology: https://510kreport.com/methodology