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510(k) Data Aggregation

    K Number
    K111066
    Device Name
    MIGRA TAB, QUICKSPLINT MIGRAINE
    Manufacturer
    MIGRATHERAPY LLC
    Date Cleared
    2011-11-22

    (218 days)

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

    MIGRATHERAPY LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Protection of teeth and restorations from injury due to bruxism or clenching. 2. Temporary relief of Temporo Mandibular joint Disorder (TMD) and bruxism by reducing muscle tension. 3. Temporary treatment of Temporal Mandibular Disorder (TMD) along with the relief of associated headaches and pains.
    Device Description
    The Brux-TMD QuickSplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid though bicuspid. It is a two-component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. The Brux-TMD QuickSplint is easily and quickly assembled in a provider's office for same day use by the patient. While it is worn, the Brux-TMD QuickSplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature an opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
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