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510(k) Data Aggregation

    K Number
    K022900
    Device Name
    BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES
    Manufacturer
    JOHN O. BUTLER CO.
    Date Cleared
    2002-11-14

    (72 days)

    Product Code
    JEQ
    Regulation Number
    872.6865
    Why did this record match?
    Applicant Name (Manufacturer) :

    JOHN O. BUTLER CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.
    Device Description
    The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.
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    K Number
    K974761
    Device Name
    BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
    Manufacturer
    JOHN O. BUTLER CO.
    Date Cleared
    1998-06-16

    (179 days)

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

    JOHN O. BUTLER CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Interdental Toothbrush Antibacterial The Butler intended to remove adherent plaque and food debris from between the teeth to reduce tooth decay. The addition of the antibacterial agent is intended to maintain the cleanliness of the interdental brush between uses and to have no effect on the user of the device.
    Device Description
    Butler Antibacterial Interdental Toothbrush
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