BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Remi Custom Night Guard

    K Number: K243516 · Decision Feb 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    2
    Review Days
    89

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    Basic Information

    Device Name
    Remi Custom Night Guard
    K Number
    K243516
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Grindguard, Inc.
    Date Received
    November 13, 2024
    Decision Date
    February 10, 2025
    Product Code
    MQC
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQC Mouthguard, Prescription

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    Other Clearances by Grindguard, Inc.

    K Number Device Name
    K251724 Remi Impression Material