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510(k) Data Aggregation

    K Number
    K073220
    Device Name
    THE DOCTOR'S NIGHTGUARD ADVANCED COMFORT
    Manufacturer
    PRESTIGE BRANDS, INC.
    Date Cleared
    2007-12-19

    (34 days)

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

    PRESTIGE BRANDS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Doctor's® NightGuard™ Advanced Comfort™ is indicated for 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.
    Device Description
    The Doctor's® NightGuard™ Advanced Comfort™ is composed of a soft, formable clear upper material, made of ELVAX® resin (a copolymer of ethylene and viny) acetate) and ELVALOY® (a copolymer of ethylene and methyl acrylate containing 9% methyl acrylate). When heated and then briefly cooled, the upper material can be molded to fit the user's upper teeth. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing. The shock absorbing polymer material cushions the teeth on all sides.
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