BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DSM Biomedical Dental Bone Graft Plus

    K Number: K193212 · Decision Sep 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    294

    Basic Information

    Device Name
    DSM Biomedical Dental Bone Graft Plus
    K Number
    K193212
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DSM Biomedical
    Date Received
    November 21, 2019
    Decision Date
    September 10, 2020
    Product Code
    NPM
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NPM Bone Grafting Material, Animal Source

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