BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S016 · Decision Mar 28, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    STRAUMANN EMDOGAIN(R)
    PMA Number
    P930021
    Supplement Number
    S016
    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
    March 28, 2017
    Date Received
    April 6, 2016
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for 1) adding an alternate glass syringe supplier (Design Change); 2) adding an alternate tamper-evident luer cap design (Design Change); 3) adding an alternate cavity design of the thermoformed tray; part of the secondary sterile barrier packaging (Design Change); 4) adding an alternate supplier of the Tyvek 1073B lid stock which includes a change in adhesive coating; part of the secondary sterile barrier packaging (Design Change); in addition, addressing the change to Transition Tyvek with this supplement; and 4) changing the configuration, artwork and labeling of the tertiary shelf packaging (Design Change).

    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