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510(k) Data Aggregation

    K Number
    K990344
    Device Name
    ORALGIENE TONGUE CLEANER
    Manufacturer
    ORALGIENE USA, INC.
    Date Cleared
    1999-05-04

    (89 days)

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

    ORALGIENE USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To remove bacterial plaque and food debris from the surface of the tongue, promoting clean mouth and fresher breath.
    Device Description
    The Oralgiene Tongue Cleaner is a "T" shaped manual device used in the same manner as other items already in the marketplace. It is all in one piece and has mild ridges, but no sharp edges. It is composed of a durable and safe plastic.
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