BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Biologic Material, Dental

    PMA: P930021 · Supplement: S014 · Decision Aug 26, 2015
    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
    S014
    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
    August 26, 2015
    Date Received
    March 2, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR ADDING THE USE OF BIPHASIC CALCIUM PHOSPHATE (HAIJ3-TCP) BONE GRAFT MATERIALS WITH STRAUMANN EMDOGAIN, ADDING THE USE OF COLLAGEN AND OTHER GRAFT MATERIALS WITH STRAUMANN EMDOGAIN AND CHANGING THE NAME OF A CONTRACT MANUFACTURER, IN NAME ONLY, FROM SVERIGE, SCAN AB TO HKSCAN SWEDEN AB. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STRAUMANN EMDOGAIN AND IS INDICATED FOR USE AS AN ADJUNCT TO PERIODONTAL SURGERY AS A TOPICAL APPLICATION ONTO EXPOSED ROOT SURFACES. EMDOGAIN IS INDICATED FOR THE TREATMENT OF THE FOLLOWING CONDITIONS:1) INTRABONY DEFECTS DUE TO MODERATE OR SEVERE PERIODONTITIS;2) MANDIBULAR DEGREE II FURCATIONS WITH MINIMAL INTERPROXIMAL BONE LOSS; 3) GINGIVAL RECESSION DEFECTS IN CONJUNCTION WITH SURGICAL COVERAGE PROCEDURES SUCH ASTHE CORONALLY ADVANCED FLAP TECHNIQUE; AND4) EMDOGAIN IS ALSO INDICATED FOR USE IN A MINIMALLY INVASIVE SURGICAL TECHNIQUE IN ESTHETIC ZONES TO OPTIMIZE TISSUE HEIGHT FOR INTRABONY DEFECTS ONLY. IN CASES OF WIDE DEFECTS OR WHERE SOFT TISSUE SUPPORT IS DESIRED, STRAUMANN EMDOGAIN CAN BE USED IN CONJUNCTION WITH A BONE GRAFT MATERIAL. FOR FURTHER INFORMATION ON THE USE OF EMDOGAIN WITH BONE GRAFT MATERIALS, PLEASE REFER TO, FOR STRAUMANN EMDOGAIN IN CONJUNCTION WITH BONE GRAFT MATERIAL IN WIDE DEFECTS IN THE CLINICAL PROCEDURE SECTION OF THE DRAFT INSTRUCTIONS.

    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