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

    CYTOPLAST REGENTEX TITANIUM 250

    K Number: K972278 · Decision Aug 6, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    225
    Applicant Total
    2
    Review Days
    49

    Basic Information

    Device Name
    CYTOPLAST REGENTEX TITANIUM 250
    K Number
    K972278
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OSTEOGENICS CO.
    Date Received
    June 18, 1997
    Decision Date
    August 6, 1997
    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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    Other Clearances by OSTEOGENICS CO.

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