# K250009: LED Curing Light (C01-X, C02-X)

- Pathway: 510(k) (Traditional)
- Applicant: Premium Plus (Dongguan) Limited
- Decided: Apr 10, 2025 after 98 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: 2 generations back to K040551 (2004). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153514: Premium Plus C01/C02 LED Curing Light, Premium Plus International Limited (2016) Summary page 5.
- K221194: LEDEX, Dentmate Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
LED Curing Light is intended for use by trained dental professionals only for the purpose of light curing dental resins and composites.

Source page: https://510kreport.com/device/K250009
Methodology: https://510kreport.com/methodology