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510(k) Data Aggregation

    K Number
    K020776
    Device Name
    MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
    Manufacturer
    CORONET GROUP NORTH AMERICA, LLC.
    Date Cleared
    2002-06-03

    (84 days)

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

    CORONET GROUP NORTH AMERICA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medoral Hygienic Toothbrush with DENTOSAN® Filaments is a toothbrush to remove plaque and debris from the teeth and prevent tooth decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on and between the bristles after and between uses.
    Device Description
    The Medoral Hygienic Toothbrush is a toothbrush with DENTOSAN® filaments. The DENTOSAN® filament is a nylon filament impregnated with an anti bacterial agent to prevent the growth of bacteria on and between the filaments after use of the toothbrush.
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