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510(k) Data Aggregation

    K Number
    K243516
    Device Name
    Remi Custom Night Guard
    Manufacturer
    GrindGuard Inc
    Date Cleared
    2025-02-10

    (89 days)

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

    GrindGuard Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Remi Night Guard is indicated for protection of teeth and restorations against grinding and clenching.
    Device Description
    The Remi Custom 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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