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

    3.25 SPLINE TWIST IMPLANT, HA COATED

    K Number: K093164 · Decision Dec 15, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    40
    Review Days
    70

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    Basic Information

    Device Name
    3.25 SPLINE TWIST IMPLANT, HA COATED
    K Number
    K093164
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Dental, Inc.
    Date Received
    October 6, 2009
    Decision Date
    December 15, 2009
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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