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

    NEOSS PROACTIVE IMPLANT

    K Number: K083561 · Decision Feb 11, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    71

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    Basic Information

    Device Name
    NEOSS PROACTIVE IMPLANT
    K Number
    K083561
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoss, Ltd.
    Date Received
    December 2, 2008
    Decision Date
    February 11, 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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    Other Clearances by Neoss, Ltd.

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    K113376 NEOSS PROACTIVE TAPERED IMPLANT
    K090452 NEOSS IMPLANT SYSTEM 03.25
    K081851 NEOSS ACCESS ABUTMENTS
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    K043195 NEO IMPLANT SYSTEM