BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GLASS MOUTH MIRRORS, REUSABLE

    K Number: K863767 · Decision Oct 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    357
    Registration Numbers
    357
    Same Product Code
    11
    Applicant Total
    16
    Review Days
    35

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    Basic Information

    Device Name
    GLASS MOUTH MIRRORS, REUSABLE
    K Number
    K863767
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    The Medical Group, Inc.
    Date Received
    September 25, 1986
    Decision Date
    October 30, 1986
    Product Code
    EAX
    Advisory Committee
    Dental
    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
    EAX Mirror, Mouth

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