BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IOX1

    Reg #: 3017403245 · FEI: 3017403245 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DENTIUM CO.,LTD(ICT BRANCH)
    Registration Number
    3017403245
    FEI Number
    3017403245
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    (16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu
    City
    Suwon Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K201247

    Owner / Operator

    Firm Name
    Dentium Co.,Ltd(ICT branch)
    Operator Number
    10076095
    Address
    (16229) 76, Changnyong-daero 256beon-gil, Yeongtong-gu
    City
    Suwon
    State
    Gyeonggi
    Postal Code
    16229
    Country
    KR
    Correspondent
    Sangwoo Lee

    Products

    Device Name Product Code
    System, X-Ray, Extraoral Source, Digital MUH
    Solid State X-Ray Imager (Flat Panel/Digital Imager) MQB

    Proprietary Names

    IOX1 IOX2

    Establishment Types

    Manufacture Medical Device