BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    DXM CO., LTD.

    Reg #: 3004082121 · FEI: 3004082121 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    32
    Establishment Types
    4
    Classifications
    14

    Registration Details

    Registration Name
    DXM CO., LTD.
    Registration Number
    3004082121
    FEI Number
    3004082121
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    102-4, Sandan-gil, Hwasun-eup
    City
    Hwasun-gun Jeonnam
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K042703

    Owner / Operator

    Firm Name
    DXM CO., LTD.
    Operator Number
    9057162
    Address
    102-4, Sandan-gil, Hwasun-eup,
    City
    Hwasun-gun
    State
    Jeonnam
    Postal Code
    58141
    Country
    KR

    US Agent

    Business Name
    Mtech Group LLC
    Contact Name
    Dave Kim
    Address
    7505 Fannin St Ste 610
    City
    Houston
    State
    TX
    ZIP
    77054
    Country
    US
    Email
    [email protected]
    Phone
    713 4672607

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ
    Heat Source For Bleaching Teeth EEG
    Needle, Dental DZM
    Protector, Dental BRW
    Light, Operating, Dental EAZ
    Syringe, Restorative And Impression Material EID
    Blade, Scalpel GES
    Pick, Massaging JET
    Unit, Operative Dental EIA
    Plugger, Root Canal, Endodontic EKR
    Aligner, Beam, X-Ray EHA
    Cup, Prophylaxis EHK
    Warmer, Anesthetic Tube EFC
    Material, Impression Tray, Resin EBH

    Proprietary Names

    D1 Cybird LED Curing Light D1-CL Cybird XD Cybird Gold Cybird Ultra ALADDIN MISO DXM BENDABLE/PRE-BEND NEEDLE TIP EZ-Bite Block, Disposable Mouth Prop Coltolux LED 2 Cybird WPT LED Curing Light MULTIPLE names and models D6 D1 LED Curing Light SPEC 3 LED 3000 DX-MIXER MIXING TIPS FOR SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL EZ VPS Connector Blade-Safe Scalpel Blade Remover EZ-Blade Remover DX-Ultra Ultrasonic Endo Activate Device Hawk Intraoral Camera and Accessories Gutta Easy Friendo Endopex DX-Condenser Multiple names DXPA DPA110 C Warmer DIBT Disposable Impression Bite Tray

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)