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510(k) Data Aggregation

    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
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LED.L, LED.M, LED.G, LED.B

    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.

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