BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IT-III active System

    Reg #: 3004730368 · FEI: 3004730368 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NEOBIOTECH CO., LTD.
    Registration Number
    3004730368
    FEI Number
    3004730368
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    70, Sinpyeong-ro, Jijeong-myeon
    City
    Wonju-si Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K181137

    Owner / Operator

    Firm Name
    NEOBIOTECH CO., LTD.
    Operator Number
    9066035
    Address
    70, Sinpyeong-ro, Jijeong-myeon
    City
    Wonju-si
    State
    Gangwon
    Postal Code
    26351
    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
    Abutment, Implant, Dental, Endosseous NHA

    Proprietary Names

    IT-III active System

    Establishment Types

    Manufacture Medical Device