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

    GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS

    K Number: K960292 · Decision Apr 15, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    30
    Applicant Total
    163
    Review Days
    84

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    Basic Information

    Device Name
    GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS
    K Number
    K960292
    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
    January 22, 1996
    Decision Date
    April 15, 1996
    Product Code
    NPK
    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
    NPK Barrier, Synthetic, Intraoral

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