BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ZENEX Implant System

    K Number: K211090 · Decision Apr 13, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    8
    Review Days
    366

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    Basic Information

    Device Name
    ZENEX Implant System
    K Number
    K211090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Izenimplant Co., Ltd.
    Date Received
    April 12, 2021
    Decision Date
    April 13, 2022
    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 Izenimplant Co., Ltd.

    K Number Device Name
    K253334 ZENEX Implant System_Short (R-System)
    K252585 ZENEX Implant System_R-System
    K240560 ZENEX Implant System_Long
    K232170 Ti Link Abutment
    K233163 ZENEX Implant System_Short
    K231557 ZENEX FreeMilling & CCM Cast Abutment
    K230630 ZENEX Implant System_Narrow