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510(k) Data Aggregation

    K Number
    K974160
    Device Name
    BRUXTRAK MATERIAL
    Manufacturer
    BRUXCARE, L.L.C.
    Date Cleared
    1998-03-11

    (126 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BRUXCARE, L.L.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Brux Trak™ material is intended for construction of temporary occlusal splints. When properly formed by a licensed dentist or lab technician and prescribed by a licensed dentist, the device is intended to do the following: - 1. Temporarily protect the teeth or dental work from damage due to teeth grinding - 2. Promote patient awareness of oro-myofacial habits, such as bruxism. - 3. Aid the dentist in locating occlusal areas of current wear - 4. Aid the dentist in evaluating and measuring the severity of a patient's current teeth grinding habits - 5. Aid the dentist in differentiating between historical tooth wear and current grinding activity. .. - 6. Provide a physical record of a patient's grinding activity for a certain time period.
    Device Description
    Brux Trak™ material is intended for construction of temporary occlusal splints.
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