BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    FX4810MLC

    Reg #: 3004578807 · FEI: 3004578807 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DENTIUM CO., LTD.
    Registration Number
    3004578807
    FEI Number
    3004578807
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    76, Changnyong-daero 256beon-gil, Yeongtong-gu
    City
    Suwon-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K041368

    Owner / Operator

    Firm Name
    Dentium USA
    Operator Number
    9063757
    Address
    6731
    City
    Cypress
    State
    CA
    Postal Code
    90630
    Country
    US

    Products

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

    Proprietary Names

    FX4810MLC FX3810MLC FX4314MLC FX3808MLC FX4808MLC FX3414MLC FX3812MLC FX4310MLC FX3410MLC FX3814MLC RAB45GN RAB45GH FX4812MLC FX4312MLC FX4814MLC FX3408MLC RAB45GNT FX4308MLC FX3412MLC

    Establishment Types

    Manufacture Medical Device