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510(k) Data Aggregation

    K Number
    K121365
    Device Name
    THERMOFORMED MOUTHGUARDS
    Manufacturer
    GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP
    Date Cleared
    2012-11-20

    (197 days)

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

    GLIDEWELL LABORATORIES-SLEEP DEVICES GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermoformed Mouthguards are intended for protection against bruxism and nighttime teeth grinding. They create a barrier between the upper and lower dentition to protect the patient's overall occlusion.
    Device Description
    The Thermoformed Mouthguards/Nightguards are designed to alleviate the pain and damage caused by bruxing or clenching of the teeth. These customized devices fit over upper or lower teeth during sleep and can offset the effects of bruxing or clenching while protecting teeth from daily wear and tear. The design of Thermoforming Mouthguards/Nightguards is the same, and the only difference is the material in terms of hardness, softness or semi-softness. Each Mouthguard/Nightguard is made with a standard flat occulusal plane and slight opposing cusp indentation to each patient's specific bite plane needs that could be determined by a dentist after diagnosis of bruxism. The Comfort H/STM Hard Soft Bite Splint is the most widely prescribed bite splint due to its comfort and fit. The soft internal surface rests comfortably against the teeth and gums, while the hard occlusal surface provides durability and bonds. Thermoformed Mouthguards/Nightguards are manufactured from biocompatible materials.
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