# K153514: Premium Plus C01/C02 LED Curing Light

- Pathway: 510(k) (Abbreviated)
- Applicant: Premium Plus International Limited
- Decided: Aug 22, 2016 after 259 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 K040551 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082408: Ledex, Model: WL-070, Dentmate Technology Co., Ltd. (2008) Summary page 4.
- K040551: Coltolux Led Curing Light, Coltene/Whaledent, Inc. (2004) Summary page 4.

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

## Indications for use
Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.

Source page: https://510kreport.com/device/K153514
Methodology: https://510kreport.com/methodology