BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    T. STRONG INC.

    Reg #: 3024859204 · FEI: 3024859204 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    20
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    T. STRONG INC.
    Registration Number
    3024859204
    FEI Number
    3024859204
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    56, Seobu-ro 346beon-gil, Jinyeong-eup
    City
    Gimhae-si Gyeongnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K132956

    Owner / Operator

    Firm Name
    T. STRONG INC.
    Operator Number
    10086215
    Address
    56, Seobu-ro 346beon-gil, Jinyeong-eup
    City
    Gimhae-si
    State
    Gyeongnam
    Postal Code
    50870
    Country
    KR
    Correspondent
    Myun-Ok Park

    US Agent

    Business Name
    Withus Group Inc
    Contact Name
    April Lee
    Address
    106 Superior
    City
    Irvine
    State
    CA
    ZIP
    92620
    Country
    US
    Email
    [email protected]
    Phone
    909 2749971

    Products

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

    Proprietary Names

    U fit Dental Implant System Fixture HandPiece Driver Hex for Digital Guide Guide Drill Fixture driver Mini Pilot Drill Step Drill Full Stop Drill Surgical Kit Twist Drill 1.2 Hex Driver for Wrench Guide Initial Drill Fixture Square Driver Hex for Digital Guide Torque Wrench for Square Driver Anchor Drill Anchor Driver Fixture Driver Reg Torque Wrench Flat Drill Drill Extension Parallal Pin Tissue Punch

    Establishment Types

    Manufacture Medical Device