BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Nexplant

    Reg #: 3009848796 · FEI: 3009848796 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ACH Medical Co., Ltd.
    Registration Number
    3009848796
    FEI Number
    3009848796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    28, Namyang-ro 930beon-gil, Namyang-eup
    City
    Hwaseong-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K120089

    Owner / Operator

    Firm Name
    ACH Medical Co., Ltd.
    Operator Number
    10043821
    Address
    28, Namyang-ro 930beon-gil, Namyang-eup
    City
    Hwaseong-si
    State
    Gyeonggi
    Postal Code
    18255
    Country
    KR
    Correspondent
    Se Hong Oh

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    18881 Von Karman Ave STE 160
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US
    Email
    [email protected]
    Phone
    714 2025789

    Products

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

    Proprietary Names

    Nexplant Zenex Blue Abutment Zenex Micro Thread Fixture Biogenesis Implant System - Aticon

    Establishment Types

    Manufacture Medical Device