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510(k) Data Aggregation

    K Number
    K110468
    Device Name
    FREEWAY COMFORT BITE GUARD
    Manufacturer
    RANDMARK DENTAL PRODUCTS, LLC
    Date Cleared
    2011-08-05

    (169 days)

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

    RANDMARK DENTAL PRODUCTS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: Protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding. Protection against teeth grinding, bruxism and jaw clenching. Rx: Short-term pain relief from muscle spasm due to occlusal interference. For the prevention of chronic tension and temporomandibular joint (TMJ) syndrome that is caused by chronic jaw clenching of the mandibular and maxillary teeth by the temporalis muscle.
    Device Description
    The Freeway Comfort" Bite Guard dental guard is composed of a moldable thermoplastic inner lining that adapts to the teeth, and a hard outer shell. The shell is composed of a hard polycarbonate material. When heated, the moldable thermoplastic material is molded to fit the user's upper anterior teeth. The hard outer shell contacts the lower anterior teeth and prevents contact of the user's posterior teeth.
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