BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S029 · Decision Nov 16, 2022
    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
    S029
    Device Class
    FDA Class 3
    Product Code
    NQA
    Generic Name
    Biologic material, dental
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Advisory Committee
    Dental
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 16, 2022
    Date Received
    October 17, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Improved settings for HPLC identification (ID) method for Emdogain (test method for in-process control and final release testing);2) Removal of redundant Acetic acid content determination (release testing);3) Removal of one redundant Calcium concentration determination (in-process control); and4) Removal of redundant sampling step on Emdogain gel bulk(in-process control.

    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