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510(k) Data Aggregation

    K Number
    K980995
    Device Name
    PLAQ-ATAQ-I
    Manufacturer
    ETHICARE
    Date Cleared
    1998-08-20

    (174 days)

    Product Code
    EFW
    Regulation Number
    872.6855
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SEE ATTACHED DEVICE SAMPLE (WHEN AVAILABLE, BRISTLE SAMPLE WILL BE SUBMITTED UPON REQUEST. BLACK DOTS INDICATE LOCATION OF THE TOOTH BRUSH BRISTLES). OUR PERFORMANCE AND REFERENCE CLAIMS TO THE USE OF THE PLAQ-ATAQ-I ARE: - 1) USED AS A REGULAR TRADITIONAL AND CURRENTLY MARKETED TOOTH BRUSH (SEE ORAL B - CREST-COMPLETE - REACH - COLGATE PLUS - TOP CARE - ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ETC., ) - 2) OVER THE COUNTER DENTIFRICE. - 3) THE LIQUID SPRAY SYSTEM INCORPORATED IN THE TOOTH BRUSH BODY CAN BE EMPLOYED FOR THE VALUES THAT THE MULTI-JETS PROVIDE. - 4) THE PLAIN TAP WATER STREAM IS FINGER-TIP CONTROLLED BY AN EASY, HAND-HELD TURNING VALVE (SEE TELEDYNE WATER PIK(R) AND HYDRO-FLOU™ MODELS). - 5) THE LIQUID STREAM FLUSHES OUT LOOSE PLAQUE AND DEBRIS BETWEEN THE TEETH AND GUMS THAT THE TOOTH BRUSH CANNOT REACH.
    Device Description
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