BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Bone Grafting Material, Dental, With Biologic Component

    PMA: P990033 · Supplement: S005 · Decision Mar 15, 2004
    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 P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
    PMA Number
    P990033
    Supplement Number
    S005
    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
    March 15, 2004
    Date Received
    November 12, 2003
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) THE ADDITION OF A PASTE FORM OF PEPGEN P-15, 2) MODIFICATION OF THE DEVICE LABELING FOR ALL PEPGEN P-15 DEVICES, AND 3) CHANGING OF THE CONTRACT MANUFACTURER FOR THE DEVICE CARRIER TO HYALURON, INC., WOBURN, MASSACHUSETTS.

    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