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510(k) Data Aggregation

    K Number
    K973424
    Device Name
    ENFRESH TONGUE BRUSH
    Manufacturer
    ENFRESH PRODUCTS LLC.
    Date Cleared
    1997-12-09

    (90 days)

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

    ENFRESH PRODUCTS LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove plaque and food debris from the surface of the tongue.
    Device Description
    The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel.
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