# K080035: Led Curing Light

- Pathway: 510(k) (Traditional)
- Applicant: Monitex Industrial Co., Ltd.
- Decided: Mar 3, 2008 after 56 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
This" LED Curing Light GT-1200" is for the polymerization of light cure materials.

Source page: https://510kreport.com/device/K080035
Methodology: https://510kreport.com/methodology