BEUDAMED
    FDA PMA FDA Class 2 Approved (Reclassification) 🇺🇸 United States

    Implant, Endosseous, Root-Form

    PMA: P860012 · Decision Oct 28, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333

    Basic Information

    Device Name
    Implant, Endosseous, Root-Form
    Trade Name
    ALVEOFORM TM BIOGRAFT
    PMA Number
    P860012
    Device Class
    FDA Class 2
    Product Code
    DZE
    Generic Name
    Implant, endosseous, root-form
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved (Reclassification)
    Decision Code
    APRL
    Decision Date
    October 28, 1988
    Date Received
    April 2, 1986
    Expedited Review
    N
    Docket Number
    89M-0003

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DZE Implant, Endosseous, Root-Form