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

    SYNTHETIC GLASS BONE GRAFT MATERIAL

    K Number: K000633 · Decision May 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    SYNTHETIC GLASS BONE GRAFT MATERIAL
    K Number
    K000633
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Blue Sky Bio
    Date Received
    February 25, 2000
    Decision Date
    May 25, 2000
    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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