BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Implant, Endosseous, Root-Form

    PMA: P800035 · Supplement: S010 · Decision Oct 4, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333

    Basic Information

    Device Name
    Implant, Endosseous, Root-Form
    Trade Name
    PERI-OSS
    PMA Number
    P800035
    Supplement Number
    S010
    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
    Decision Code
    APPR
    Decision Date
    October 4, 2001
    Date Received
    June 25, 2001
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A NEW TRADE NAME. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PERI-OSS AND IS INDICATED FOR REPAIR OF PERIODONTAL AND PERIAPICAL BONY DEFECTS.

    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