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

    FREEWAY COMFORT BITE GUARD

    K Number: K110468 · Decision Aug 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    70
    Applicant Total
    1
    Review Days
    169

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    FREEWAY COMFORT BITE GUARD
    K Number
    K110468
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Randmark Dental Products, LLC
    Date Received
    February 17, 2011
    Decision Date
    August 5, 2011
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQC), ordered by most recent decision date.

    UltraPrint-Dental Hard Splint UV

    FDA 510(k)
    FDA Unclassified ·Unknown

    Remvia NightGuard

    FDA 510(k)
    FDA Unclassified ·Unknown

    NOBILCAM IMPAK Disc

    FDA 510(k)
    FDA Unclassified ·Unknown

    Hard Splint & Thermo-Adaptive Splint

    FDA 510(k)
    FDA Unclassified ·Unknown

    Remi Custom Night Guard

    FDA 510(k)
    FDA Unclassified ·Unknown

    LIJIA Night Guard

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all