BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P040013 · Supplement: S023 · Decision Jun 17, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Bone Grafting Material, Dental, With Biologic Component
    Trade Name
    GEM215 Growth Factor Enhanced Matrix
    PMA Number
    P040013
    Supplement Number
    S023
    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
    Approved
    Decision Code
    APPR
    Decision Date
    June 17, 2020
    Date Received
    March 24, 2020
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for change of the supplier from STERIS (formerly Synergy Health) in Swindon, United Kingdom (STERIS Swindon), to the STERIS AST facility located at 9 Apollo Drive, Whippany, New Jersey, United States (STERIS Whippany), for sterilization of the ?-TCP cup component of the GEM21S device.

    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