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

    STRAUMANN BONE LEVEL TAPERED IMPLANT

    K Number: K140878 · Decision Aug 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    24
    Review Days
    135

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    Basic Information

    Device Name
    STRAUMANN BONE LEVEL TAPERED IMPLANT
    K Number
    K140878
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann USA, LLC
    Date Received
    April 7, 2014
    Decision Date
    August 20, 2014
    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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