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

    MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE

    K Number: K032750 · Decision Oct 2, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    2
    Review Days
    27

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    Basic Information

    Device Name
    MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE
    K Number
    K032750
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Friandent GmbH
    Date Received
    September 5, 2003
    Decision Date
    October 2, 2003
    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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    Other Clearances by Friandent GmbH

    K Number Device Name
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