BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ODS CO., LTD.

    Reg #: 3017210293 · FEI: 3017210293 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ODS CO., LTD.
    Registration Number
    3017210293
    FEI Number
    3017210293
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #1204 (SmartValley D B/D, 30, Songdomirae-ro, Yeonsugu
    City
    Incheon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251616

    Owner / Operator

    Firm Name
    ODS Co., Ltd.
    Operator Number
    10074605
    Address
    #1204 (SmartValley D B/D, 30, Songdomirae-ro, Yeonsugu
    City
    Incheon
    State
    KR-28
    Postal Code
    21990
    Country
    KR
    Correspondent
    KYUNGRAN BACK

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 Lafayette Dr
    City
    Novi
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 6297552

    Products

    Device Name Product Code
    Maintainer, Space Preformed, Orthodontic DYT
    Accessories, Implant, Dental, Endosseous NDP
    Aligner, Sequential NXC
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    ODS Clear Resin - Retainer ODS Surgical Guide Clear Miracle Scan Cure (SC-80)

    Establishment Types

    Manufacture Medical Device