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

    ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD

    K Number: K013650 · Decision Dec 6, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    205
    Applicant Total
    42
    Review Days
    30

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    Basic Information

    Device Name
    ORTHOPHOS DS/DC CEPH, ORTHOPHOS 5/PLUS/CD
    K Number
    K013650
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.1800
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sirona Dental Systems GmbH
    Date Received
    November 6, 2001
    Decision Date
    December 6, 2001
    Product Code
    MUH
    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
    MUH System, X-Ray, Extraoral Source, Digital

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