# K131042: LEDEX

- Pathway: 510(k) (Traditional)
- Applicant: Dentmate Technology Co., Ltd.
- Decided: Oct 3, 2013 after 171 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K221194: LEDEX (2022), 1 descendant of its own
- K250009: LED Curing Light (C01-X, C02-X) (2025), 0 descendants of its own

## Indications for use
LEDEX (Family mode!: WIL-090, WL-090+) Is a visible-curing unit programmed for polymerization of dental light cured materials by dental professionals.

Source page: https://510kreport.com/device/K131042
Methodology: https://510kreport.com/methodology