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510(k) Data Aggregation

    K Number
    K063704
    Device Name
    BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101
    Manufacturer
    BEKS INCORPORATED
    Date Cleared
    2007-02-20

    (69 days)

    Product Code
    EEG
    Regulation Number
    872.6475
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEKS INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BriteWhite Teeth Whitening System is intended to emit light in the 400 nanometer spectrum to provide a light source for the bleaching of teeth.
    Device Description
    The BriteWhite Teeth Whitening System device that utilizes Light Emitting Diodes to provide a tooth whitening system, the whitening light source is a mouth piece which is placed inside the mouth, using barrier sleeves, which emits a biologically safe and effective level of blue visible light. The general wavelength for the mouth piece is 400 nanometer spectrums to provide a selected wavelength which activates the whitening gel to bleach the teeth without the aide of heat. To ensure user safety when operating the light, the system has a built in feature to eliminate any risk for the end user and professional. The light automatically shuts off after a specified period of time. Secondly, the light source in placed inside the mouth, so there is no need for safety glasses for the patient and professional. No contact with the eyes is in this area of treatment and prevents penetrations of blue wavelength and protects the vision of the patient and professional.
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