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510(k) Data Aggregation

    K Number
    K090472
    Device Name
    GRIND GUARD
    Manufacturer
    ARCHTEK, INC.
    Date Cleared
    2009-10-14

    (232 days)

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

    ARCHTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prescription indications: To protect against tooth damage bruxism and clenching caused by occlusal interferences, Provide short term relief from muscle spasm due to occlusal interferences, and Prevention of pain and chronic tension of temporomandibular joint syndrome components that are caused by chronic jaw clenching.
    Device Description
    The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth; shock-absorbing material cushions teeth on all sides. This device may not be used as an athletic mouth guard. This device should not be used by persons under the age of 18.
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    K Number
    K073446
    Device Name
    GRIND GUARD
    Manufacturer
    ARCHTEK, INC.
    Date Cleared
    2008-02-08

    (63 days)

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

    ARCHTEK, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Protection against bruxism or nighttime teeth grinding; to reduce damage to teeth, and to prevent the noise associated with bruxism or grinding.
    Device Description
    The Grind Guard is appliance is to be worn at night, covering the teeth of the upper arch, as a protection for those who suffer form the night time grinding of the teeth. It is composed of a soft, thermoformable material that is heated and briefly cooled and molded to fit user's upper teeth: shock-absorbing material cushions teeth on all sides during nocturnal bruxing.
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