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

    REGENEROSS ALLOGRAFT PLUS MINERLIZED

    K Number: K113645 · Decision Jan 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    39

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    Basic Information

    Device Name
    REGENEROSS ALLOGRAFT PLUS MINERLIZED
    K Number
    K113645
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Interpore Cross
    Date Received
    December 12, 2011
    Decision Date
    January 20, 2012
    Product Code
    NUN
    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
    NUN Bone Grafting Material, Human Source

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