BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ZENEX Implant System_Long

    Reg #: 3031493119 · FEI: 3031493119 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IZENIMPLANT CO., LTD.
    Registration Number
    3031493119
    FEI Number
    3031493119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30, Jeongnamsandan 1-gil, Jeongnam-myeon
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240560

    Owner / Operator

    Firm Name
    Izenimplant Co., Ltd.
    Operator Number
    10080021
    Address
    1, 2Dong, 26-32, Suworam 4-gil, Seotan-myeon
    City
    Pyeongtaek-si
    State
    Gyeonggi
    Postal Code
    17703
    Country
    KR

    US Agent

    Business Name
    Withus Group Inc.
    Contact Name
    April Lee
    Address
    106 Superior
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    909 2749971

    Products

    Device Name Product Code
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    ZENEX Implant System_Long

    Establishment Types

    Manufacture Medical Device