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510(k) Data Aggregation

    K Number
    K132469
    Device Name
    THE BITE GUARD
    Manufacturer
    INTERNATIONAL PROFIT BUILDERS, INC.
    Date Cleared
    2014-02-28

    (205 days)

    Product Code
    OBR
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTERNATIONAL PROFIT BUILDERS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Bite Guard" Is used To Prevent grinding of the teeth, jaw clenching and to reduce damage to feeth from grinding .
    Device Description
    "The Bite Guard" is a flexible and moldable dental protector which is a comfortable mouth guard as a barrier between teeth for individuals who grind their teeth. Submerging the device into boiling water allows it to be molded to fit the patient's oral cavity exclusively. "The Bite Guard" is shaped like a dental arch and is constructed of a propylene-based elastomer.
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