BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S011 · Decision Jun 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5

    Basic Information

    Device Name
    Biologic Material, Dental
    Trade Name
    EMDOGAIN
    PMA Number
    P930021
    Supplement Number
    S011
    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
    June 19, 2009
    Date Received
    March 27, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING: 1) THE USE OF STRAUMANN EMDOGAIN WITH BONE SUBSTITUTE MATERIAL, SUCH AS STRAUMANN BONE CERAMIC; 2) LABELING CHANGES TO MODIFY A STATEMENT REGARDING THE LONG TERM STABILITY OF REGENERATED TISSUE; 3) LABELING CHANGE TO ADD ADDITIONAL SURGICAL TECHNIQUES FOR THE TREATMENT OF GINGIVAL RECESSION DEFECTS; 4) LABELING CHANGE TO INCLUDE INSTRUCTIONS IN THE ¿STORAGE¿ SECTION IN INSTRUCTIONS FOR USE FOR HOMOGENIZATION IF THE MATERIAL IS SEPARATED IN THE SYRINGE; AND 5) CLARIFY THE INSTRUCTIONS UNDER EACH OF THE THREE CLINICAL PROCEDURES IN THE INSTRUCTIONS FOR USE TO BETTER ALIGN THEM WITH ONE ANOTHER.

    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