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K Number
K080025
Device Name
LED.L, LED.M, LED.G, LED.B
Manufacturer
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
Date Cleared
2008-03-19

(75 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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 490nrn. This is the applicable range for dental Curing of camphor quinine (CPQ) containing products.

Device Description

Dental Curing Light Models LED.L, LED.M, LED.G, LED.B

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide the acceptance criteria and study as the document is a 510(k) clearance letter for a dental curing light and does not contain information about acceptance criteria, study details, or ground truth establishment. The letter primarily confirms that the device is substantially equivalent to a predicate device and can be marketed.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.