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510(k) Data Aggregation

    K Number
    K980075
    Device Name
    CYBERSONIC
    Manufacturer
    AMERICAN DENTRONICS, INC.
    Date Cleared
    1998-03-04

    (55 days)

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

    AMERICAN DENTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.
    Device Description
    Not Found
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