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510(k) Data Aggregation

    K Number
    K221369
    Device Name
    FBCC Night Guard
    Manufacturer
    FBCC Inc
    Date Cleared
    2022-11-18

    (190 days)

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

    FBCC Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FBCC Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
    Device Description
    The FBCC Night Guard is a mouth guard used as a barrier between teeth for nighttime teeth grinding by creating physical separation between upper and lower tooth surfaces preventing tooth damage caused by bruxism (e.g., grinding and clenching).
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