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510(k) Data Aggregation

    K Number
    K983683
    Device Name
    UNIK TONGUE CLEANER
    Manufacturer
    UNIK PRODUCTS, INC.
    Date Cleared
    1999-01-14

    (86 days)

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

    UNIK PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the Unik Tongue Cleaner is to remove bacteria from and prevent plaque build-up on the tongue to help fight bad breath and promote oral hygiene.
    Device Description
    This is a device consisting of a molded polypropylene plastic handle, similar in appearance to that of a toothbrush, and a U-shaped loop end made of either polypropylene plastic or stainless steel. The device is used by placing the loop end at the back of the tongue and gently dragging it toward the front. The device is designed so that there are no sharp edges.
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