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

    ORMCO TRANSMANDIBULAR IMPLANT

    K Number: K852894 · Decision Aug 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    40
    Review Days
    51

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    Basic Information

    Device Name
    ORMCO TRANSMANDIBULAR IMPLANT
    K Number
    K852894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Unknown
    Applicant
    Ormco Corp.
    Date Received
    July 9, 1985
    Decision Date
    August 29, 1985
    Product Code
    MDL
    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
    MDL Implant, Transmandibular

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