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

    ENDOBON XENOGRAFT GRANULES

    K Number: K110449 · Decision May 13, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    225
    Applicant Total
    9
    Review Days
    86

    Basic Information

    Device Name
    ENDOBON XENOGRAFT GRANULES
    K Number
    K110449
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BIOMET 3I
    Date Received
    February 16, 2011
    Decision Date
    May 13, 2011
    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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