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510(k) Data Aggregation

    K Number
    K033697
    Device Name
    POWER LED
    Date Cleared
    2004-02-27

    (94 days)

    Product Code
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL PRODUCTS OF USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of Power LED is to act as a polymerization source using visible light to cure composite resins.
    Device Description
    The Power LED Cordless Curing Light is a device used for the polymerization of dental materials using visible light. It consists of a cordless LED curing handpiece, a battery charger and a remote handpiece holder. The plastic molded handpiece will contain a detachable rechargeable battery pack, an LED light "engine". A printed circuit board with a digital circuit will be utilized to control four different curing modes. Each mode specifies LED timing and audible beep timing. A segmented display will depict the curing modes. A separate pushbutton will activate the light. The molded plastic battery charger will have a single well for charging the battery pack, and Indictor lights to indicate battery charge status.
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