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510(k) Data Aggregation

    K Number
    K072147
    Device Name
    DEN TEK COMFORT FIT NIGHTGUARD
    Manufacturer
    DEN TEK ORAL CARE, INC.
    Date Cleared
    2007-08-30

    (27 days)

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

    DEN TEK ORAL CARE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DenTek Comfort Fit is indicated for use 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 Comfort Fit consists of two bite pads and one buccal retaining strap. The bite pads consist entirely of Elvax, and the buccal retaining strap consists of Elvaloy. The bite pads move along the buccal strap to adjust to the individual user needs with the strap always contained within the wings of the bite pads. There are 4 positions of adjustability for each molar pad. There is a built in wear indicator, which helps the user determine when they need to replace their Comfort Fit.
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