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

    RETRO MIRROR

    K Number: K941574 · Decision May 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    357
    Registration Numbers
    357
    Same Product Code
    11
    Applicant Total
    14
    Review Days
    48

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    Basic Information

    Device Name
    RETRO MIRROR
    K Number
    K941574
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.4565
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Union Broach, Div. Moyco Industries, Inc.
    Date Received
    March 31, 1994
    Decision Date
    May 18, 1994
    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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