# K221194: LEDEX

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentmate Technology Co., Ltd.
- Decided: Sep 16, 2022 after 144 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
Longest line of descent: 1 generation back to K131042 (2013). 1 ancestor in all.
1 later device descends 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)
- K131042: LEDEX, Dentmate Technology Co., Ltd. (2013) Summary page 5.

## Most influential descendants
- K250009: LED Curing Light (C01-X, C02-X) (2025), 0 descendants of its own

## Indications for use
LEDEX WL-120 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.

Source page: https://510kreport.com/device/K221194
Methodology: https://510kreport.com/methodology