BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PLASTICEPH

    K Number: K810538 · Decision Apr 29, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    PLASTICEPH
    K Number
    K810538
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.1830
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Morningstar Dental Co.
    Date Received
    February 26, 1981
    Decision Date
    April 29, 1981
    Product Code
    EAG
    Advisory Committee
    Dental
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EAG Cephalometer

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