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

    BOND APATITE

    K Number: K121177 · Decision Dec 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    225
    Applicant Total
    2
    Review Days
    596

    Basic Information

    Device Name
    BOND APATITE
    K Number
    K121177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AUGMA BIOMATERIALS, LTD.
    Date Received
    April 18, 2012
    Decision Date
    December 5, 2013
    Product Code
    LYC
    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
    LYC Bone Grafting Material, Synthetic

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