BEUDAMED
    FDA Registration Inactive 🇰🇷 South Korea

    HIGHNESS IMPLANT SYSTEM

    · Expires 2025
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HIGHNESS CO.,LTD.
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    98-10, Hyeondae-ro, Waegwan-eup, Chilgok-gun
    City
    Gyeongsangbuk-do Gyeongbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240383

    Owner / Operator

    Firm Name
    highness Co.,Ltd.
    Operator Number
    10093674
    Address
    98-10, Hyeondae-ro, Waegwan-eup, Chilgok-gun
    City
    Gyeongsangbuk-do
    State
    Gyeongbuk
    Postal Code
    39871
    Country
    KR
    Correspondent
    Ji-yun Jeong

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 Lafayette Dr
    City
    Novi
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 6297552

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE

    Proprietary Names

    HIGHNESS IMPLANT SYSTEM

    Establishment Types

    Manufacture Medical Device