BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S017 · Decision Feb 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    STRAUMANN EMDOGAIN
    PMA Number
    P930021
    Supplement Number
    S017
    Device Class
    FDA Class 3
    Product Code
    NQA
    Generic Name
    Biologic material, dental
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 17, 2017
    Date Received
    September 9, 2016
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for design changes to the syringe packaging and manufacturing changes for in-house secondary packaging by Biora AB.

    Classifications

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

    Product Code Device Name
    NQA Biologic Material, Dental