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

    GORE RESOLUT XT REGENERATIVE MATERIAL

    K Number: K973594 · Decision Dec 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    229
    Applicant Total
    163
    Review Days
    86

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    Basic Information

    Device Name
    GORE RESOLUT XT REGENERATIVE MATERIAL
    K Number
    K973594
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3930
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    W. L. Gore & Associates, Inc.
    Date Received
    September 22, 1997
    Decision Date
    December 17, 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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