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

    Ti Link Abutment

    K Number: K232170 · Decision Jan 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    382
    Registration Numbers
    382
    Same Product Code
    708
    Applicant Total
    8
    Review Days
    175

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    Basic Information

    Device Name
    Ti Link Abutment
    K Number
    K232170
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Izenimplant Co., Ltd.
    Date Received
    July 21, 2023
    Decision Date
    January 12, 2024
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by Izenimplant Co., Ltd.

    K Number Device Name
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    K233163 ZENEX Implant System_Short
    K231557 ZENEX FreeMilling & CCM Cast Abutment
    K230630 ZENEX Implant System_Narrow
    K211090 ZENEX Implant System