# K061695: Led Prolux 770

- Pathway: 510(k) (Traditional)
- Applicant: Peng Lim Enterprise Co., Ltd.
- Decided: Sep 14, 2006 after 91 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 K023545 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040618: Led Turbo, Apoza Enterprise Co., Ltd. (2004) Summary page 1.

## Indications for use
This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

Source page: https://510kreport.com/device/K061695
Methodology: https://510kreport.com/methodology