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

    SM IMPLANT SYSTEMS

    K Number: K061797 · Decision Sep 1, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    8
    Review Days
    67

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    Basic Information

    Device Name
    SM IMPLANT SYSTEMS
    K Number
    K061797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dio Department Dsi, Inc.
    Date Received
    June 26, 2006
    Decision Date
    September 1, 2006
    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 Dio Department Dsi, Inc.

    K Number Device Name
    K080129 SECURE IMPLANT SYSTEM (2.5/3.0MM)
    K073070 DIO BIOTITE-H IMPLANT SYSTEM
    K080128 SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
    K070570 DIO IMPLANT SYSTEM
    K080126 DIO PROTEM IMPLANT SYSTEM
    K070569 SM INTERNAL./EXTERNAL IMPLANT SYSTEM
    K070568 DIO PROTEM IMPLANT SYSTEM