BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P050053 · Supplement: S065 · Decision Mar 19, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Bone Grafting Material, Dental, With Biologic Component
    Trade Name
    INFUSE® Bone Graft
    PMA Number
    P050053
    Supplement Number
    S065
    Device Class
    FDA Class 3
    Product Code
    NPZ
    Generic Name
    Bone grafting material, dental, with biologic component
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 19, 2025
    Date Received
    March 10, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    change of the current ePCD for ethylene oxide sterilization, change to the temperature and relative humidity monitoring, change to the finished good release of the collagen based medical devices

    Classifications

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

    Product Code Device Name
    NPZ Bone Grafting Material, Dental, With Biologic Component