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

    SCREW-VENT DENTAL IMPLANT SYSTEM

    K Number: K011028 · Decision May 21, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    9
    Review Days
    46

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    Basic Information

    Device Name
    SCREW-VENT DENTAL IMPLANT SYSTEM
    K Number
    K011028
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sulzer Dental, Inc.
    Date Received
    April 5, 2001
    Decision Date
    May 21, 2001
    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 Sulzer Dental, Inc.

    K Number Device Name
    K014050 HEX-LOCK TEMPORARY ABUTMENT
    K014175 SULZER DENTAL CERAMIC SYSTEM-HEXLOCK
    K014214 SULZER DENTAL CERAMIC SYSTEM-SPLINE
    K013494 3.75MM AND 5.0MM SPLINE TWIST IMPLANT
    K013227 SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT
    K012055 3.25MM SPLINE TWIST IMPLANT
    K011245 ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM
    K011038 TAPER-LOCK DENTAL IMPLANT SYSTEM