BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P990033 · Supplement: S001 · Decision Jan 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6

    Basic Information

    Device Name
    Bone Grafting Material, Dental, With Biologic Component
    Trade Name
    PEPGEN-P15
    PMA Number
    P990033
    Supplement Number
    S001
    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
    January 27, 2000
    Date Received
    November 8, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval is for a new sterilization facility located at STERIS-Isomedix Services, 9120 South 150 East, Sandy, Utah.

    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