# K060646: Blue Luxcer Curing Light, Models M-830, M-835 and M-855

- Pathway: 510(k) (Traditional)
- Applicant: Monitex Industrial Co., Ltd.
- Decided: Apr 21, 2006 after 42 days
- Product code: EBZ (Activator, Ultraviolet, For Polymerization)
- Device class: 2
- Regulation: 21 CFR 872.6070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K020091 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033201: LA500 Blue Light, Apoza Enterprise Co., Ltd. (2003) Summary page 1.

## Recalls of this device
- Apr 4, 2018 · Class II · Z-0797-2019: Tip of the curing light was too hot causing a heat sensation in the patients.

## Indications for use
This Blue Luxceir, Curing Light is a visible curing unit programmed for polymerization of light cured materials by dental professionals.

Source page: https://510kreport.com/device/K060646
Methodology: https://510kreport.com/methodology