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

    MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS

    K Number: K090260 · Decision Feb 26, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    4
    Review Days
    23

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    Basic Information

    Device Name
    MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS
    K Number
    K090260
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Straumann Manufacturing, Inc.
    Date Received
    February 3, 2009
    Decision Date
    February 26, 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 Straumann Manufacturing, Inc.

    K Number Device Name
    K092814 STRAUMANN DENTAL ABUTMENTS
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    K070478 P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)