BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    KJ MEDITECH CO., LTD.

    Reg #: 3008959419 · FEI: 3008959419 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    30
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    KJ MEDITECH CO., LTD.
    Registration Number
    3008959419
    FEI Number
    3008959419
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21, Cheomdan venture-ro, 40 beon-gil, Buk-gu
    City
    Gwangju
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K140051

    Owner / Operator

    Firm Name
    KJ Meditech Co., Ltd.
    Operator Number
    10035757
    Address
    21, Cheomdan venture-ro, 40 beon-gil, Buk-gu
    City
    Gwangju
    State
    KR-NOTA
    Postal Code
    61009
    Country
    KR
    Correspondent
    Hyukki Moon

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Abutment, Implant, Dental, Endosseous NHA
    Implant, Endosseous, Root-Form DZE
    Headgear, Extraoral, Orthodontic DZB
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    KJ EXTERNAL IMPLANT SYSTEM J2A Dental Implant System J2C Dental Implant System KERATOR Kerator KJ MASK IS DENTAL IMPLANT SYSTEM HERO II DENTAL IMPLANT SYSTEM JR IMPLANT SYSTEM OSSEOFUSE DENTAL IMPLANT SYSTEM J2A SLA Dental Implant System Conical Plus Implant System Anchor plus Neo Anchor plus ONE PLUS IMPLANT SYSTEM J2I IMPLANT SYSTEM LOTA SLA Dental Implant System LOTA HA Dental Implant System KJ Zirconia Implant System KJ Mini Implant System Dental Implant Removal Dental Implant Attachment Components Dental Implant Impression Components Dental Implant Comfort Cap Dental Implant Drivers Dental Implant Analog Dental Implant Surgical Drills Dental Osteotomes KJ Submerged System HERO I DENTAL IMPLANT SYSTEM

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Sterilize Medical Device for Another Party (Contract Sterilizer)