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510(k) Data Aggregation

    K Number
    K181361
    Device Name
    Brux Night Guard
    Manufacturer
    Brux Night Guard
    Date Cleared
    2019-04-11

    (323 days)

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

    Brux Night Guard

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Brux Night Guard is indicated 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
    Not Found
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