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510(k) Data Aggregation

    K Number
    K063483
    Device Name
    DEN TEK NIGHTGUARD
    Manufacturer
    DENTEK ORAL CARE, INC.
    Date Cleared
    2007-01-23

    (67 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K053580
    Why did this record match?
    Device Name :

    DEN TEK NIGHTGUARD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DenTek NightGuard 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 teeth grinding.

    Device Description

    The DenTek NightGuard is composed of a soft, formable material made of a blend of ethylene vinyl acetates, and non-formable occlusal base, which cushions the teeth. The base is composed of a copolymer of ethylene and methyl acrylate. When heated and then briefly cooled, the formable material is molded to fit the user's upper teeth for maximum retention. The hard base prevents bite-through by users with moderate to severe nocturnal bruxing and cushions the teeth on all occlusal surfaces. The DenTek NightGuard is designed with three flex points that allow for expansion and contraction of the device to fit most mouth sizes.

    AI/ML Overview

    {"box_2_1": "No performance data is required for the DenTek NightGuard in support of this 510(k) notice. The device demonstrated substantial equivalence to a predicate device based on having the same intended uses, indications, principles of operation, and similar technological characteristics, without raising new questions of safety or effectiveness."}

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