BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TS Implant System

    Reg #: 3003394081 · FEI: 3003394081 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    OSSTEM IMPLANT CO., LTD.
    Registration Number
    3003394081
    FEI Number
    3003394081
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    66-16, Bansong-ro 513beon-gil,
    City
    Haeundae-gu Busan
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K121585

    Owner / Operator

    Firm Name
    OSSTEM IMPLANT CO LTD
    Operator Number
    9062743
    Address
    66-16, Bansong-ro 513beon-gil,
    City
    Haeundae-gu
    State
    Busan
    Postal Code
    48002
    Country
    KR

    US Agent

    Business Name
    HIOSSEN, Inc.
    Contact Name
    Mateusz Leszczak
    Address
    85 Ben Fairless Drive
    City
    Fairless Hills
    State
    PA
    ZIP
    19030
    Country
    US
    Email
    [email protected]
    Phone
    201 2660657

    Products

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

    Proprietary Names

    TS Implant System

    Establishment Types

    Manufacture Medical Device