# K082408: Ledex, Model: WL-070

- Pathway: 510(k) (Traditional)
- Applicant: Dentmate Technology Co., Ltd.
- Decided: Dec 3, 2008 after 104 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
- 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

## Indications for use
This LEDEX WL-070 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Source page: https://510kreport.com/device/K082408
Methodology: https://510kreport.com/methodology