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510(k) Data Aggregation

    K Number
    K172452
    Device Name
    Bruxor
    Manufacturer
    Sleep Specialties, LLC
    Date Cleared
    2018-01-11

    (150 days)

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

    Sleep Specialties, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Bruxor™ is intended to protect teeth and reduce the damage caused by bruxing, or night time teeth grinding, and to prevent the noise associated with bruxing and grinding.
    Device Description
    The Bruxor mouthguard consists of a single 'boil & bite' tray, fabricated from a thermoplastic resin, that fits over the upper dental arch.
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