BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SOFX483812S

    Reg #: 3004578807 · FEI: 3004578807 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    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
    K102308

    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

    SOFX483812S SOFX654808R SOFX483808R SOFX483810R SOFX654810S SOFX654308S SOFX484310S SOFX483808S SOFX483410R SOFX484310R SOFX484312S SOFX654308R SOFX483810S SOFX483412R SOFX484308R SOFX654808S SOFX483408R SOFX654812S SOFX654310R SOFX654810R SOFX484308S SOFX654312S SOFX483812R

    Establishment Types

    Manufacture Medical Device