BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Ni2 Implant System

    Reg #: 3026365523 · FEI: 3026365523 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IDIS CO., LTD.
    Registration Number
    3026365523
    FEI Number
    3026365523
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #1314 ~ #1319, 122, Jomaru-ro, 385 beon gil,
    City
    Bucheon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K221847

    Owner / Operator

    Firm Name
    IDIS Co. Ltd.
    Operator Number
    10089789
    Address
    #1314 ~ #1319, 122, Jomaru-ro, 385 beon gil,
    City
    Bucheon-si
    State
    Gyeonggi
    Postal Code
    14556
    Country
    KR
    Correspondent
    TAI WON SON

    US Agent

    Business Name
    Provision Consulting Group, Inc.
    Contact Name
    Joyce Kwon
    Address
    13925 City Center Dr Ste 200
    City
    Chino Hills
    State
    CA
    ZIP
    91709
    Country
    US
    Email
    [email protected]
    Phone
    909 4933276

    Products

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

    Proprietary Names

    Ni2 Implant System

    Establishment Types

    Manufacture Medical Device