BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    IH Implant System

    Reg #: 3013271380 · FEI: 3013271380 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SEWON MEDIX, INC.
    Registration Number
    3013271380
    FEI Number
    3013271380
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #29, Sasang-ro, 375 beon-gil, Sasang-gu
    City
    Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K153521

    Owner / Operator

    Firm Name
    Sewon Medix, Inc.
    Operator Number
    10053110
    Address
    #29, Sasang-ro, 375 beon-gil, Sasang-gu
    City
    Busan
    State
    KR-26
    Postal Code
    46946
    Country
    KR
    Correspondent
    Jinsoo Lee

    Products

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

    Proprietary Names

    IH Implant System

    Establishment Types

    Manufacture Medical Device