# K080025: Led.L, Led.M, Led.G, Led.B

- Pathway: 510(k) (Traditional)
- Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
- Decided: Mar 19, 2008 after 75 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
WOODPECKER Curing light LED.L, LED.M, LED.G, LED.B with blue LED is a device which generates high intensity light for polymerization of light-curing materials used for dental curing purpose. Unlike Halogen light generating full light spectrum, it only emits light with wavelength primarily in the range: of 440 to 490nm. This is the applicable range for dental Curing of camphor quinine (CPQ) containing products.

Source page: https://510kreport.com/device/K080025
Methodology: https://510kreport.com/methodology