BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    MegaGen Implant Co., Ltd. (Research Laboratories)

    Reg #: 3030089802 · FEI: 3030089802 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    226
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    MegaGen Implant Co., Ltd. (Research Laboratories)
    Registration Number
    3030089802
    FEI Number
    3030089802
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19, Alphacity 1-ro 31-gil, Suseong-gu
    City
    Daegu
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K231967

    Owner / Operator

    Firm Name
    MEGAGEN IMPLANT CO. LTD
    Operator Number
    9067358
    Address
    45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
    City
    Daegu
    State
    KR-NOTA
    Postal Code
    42921
    Country
    KR
    Correspondent
    Kwang Bum Park

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Elevator, Surgical, Dental EMJ
    Implant, Endosseous, Root-Form DZE
    Abutment, Implant, Dental, Endosseous NHA
    X-Ray, Tomography, Computed, Dental OAS
    Chair, Surgical, Ac-Powered GBB
    Chair, Dental, Without Operative Unit NRU
    Evacuator, Oral Cavity EHZ
    Unit, Operative Dental EIA
    Drill, Dental, Intraoral DZA
    Accessories, Implant, Dental, Endosseous NDP
    Attachment, Precision, All EGG
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
    Plate, Bone JEY
    Light, Operating, Dental EAZ
    Fixture Mount Kit NYE
    Instrument, Filling, Plastic, Dental EIY
    Bur, Dental EJL
    Knife, Periodontic EMO
    Tray, Impression, Preformed EHY

    Proprietary Names

    Core Lifter 1 Core Lifter 2 ARi ExCon Implant System MegaGen Dental Implant Abutment Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment RCT820-SC RCT820 R2 STUDIO Q N2C Multi-unit Abutment, Multi-unit Angled Abutment ST Internal Implant System Exfeel Implant System XPEED AnyRidge Internal Implant System Rescue Implant System 2nd Assi Dr. Vortex Cover Screw Healing Abutment MegaGen Dental Implant Systems Portfolio MiNi Internal Implant System EZ Plus Implant System N2 BLUEDIAMOND IMPLANT Stopper Drill Dense Drill Initial Drill CASA Drill Lindermann Drill Flattening Lance Reverse Drill Trephine Bur Carbide Round Bur Flattening Drill Step Drill Tap Drill Final Shaper Drill Cortical Bone Drill Bottom Drill Second Drill Lindermann Bur Shaping Drill Auto-Max Diamond Drill Point Trephine Bur TiGEN Abutment Scan Healing Abutment ZrGEN Abutment AnyOne Internal Implant System Intermezzo Implant System AnyRidge Internal Implant System Scan Bar Screw Lateral Sinus Graft System Short Implant Solution AXA Scanbody Kit for R2 Photogram Removal Screw MUA Scanbody Kit for R2 Photogram Drill Stopper Multi-unit Driver AXA Scanbody for R2 Phtogram MUA Scanbody for R2 Photogram Kit Case Scan Abutment Plastic Cylinder RP Analog Torque Wrench & Adaptor Bur Stopper Jig Screw Remover Guide Holder Impression Coping Plastic Abutment Lab Analog Stopper Holder Scan Post Carrier Direction Indicator Path Finder Easy Crown Analog Stopper Stainless Steel Housing Square Driver Insert Driver B.I.C Carrier Ratchet Connector Cylinder Screw Anatomic Healing Abutment Case Removal Driver Bone Splitter 1 Screw Tapping Driver Reverse Scan Strong Wrench S.H.A Carrier Ez Crown Impression Coping Sinus Elevator Plastic Impression Coping Handpiece Connector Stainless Impression Coping Bone Carrier Implant Remover Screw Scan Abutment Screw Multi-Unit Carrier Retentive Cap Removal Tool Protective Disk Implant Remover Tissue Punch Trephine Stopper Jig Slot Driver Multi-Unit-Detector Set Ti Base Detector Set Burn-Out Cylinder Multi-Unit-Detector Retentive Cap Insertion Tool Drill Stopper Jig Crown Screw Receiver AXA Carrier Surgical Guide Guide Pin Ti Base Detector Scan Cap Ratchet Wrench Bite Impression Coping Retractor Screw Driver Drill Extension Bone Condenser Stopper Holder Jig Bone Splitter 2 Bone Profiler Guide Pin Jig Multi Post Screw Flattening Drill Housing Surgical Kit Case Mount Removal Driver Right Angle Driver Bur Stopper Depth Gauge Bite Impression Cap Analog Screw Hand Tap Milling Screw Bone Profiler & Bone Profiler Guide Pin Fixture Driver Grafting Pin Scan Bar Reamer Drill & Center Pin Surgical Kit Plastic Case AXA Driver Multi Tool, Magnetic Positioner, Housing Positioner Reverse Jig Connector Implant Tapping Remover EZ Draw Solid Driver & Solid Post Driver i-Peg Try-In Abutment Analog B.I.C Guide Pin Socket Driver Selection Guide Pin Connection Repair Tool i-Peg Mount Hand Driver Final Driver Retentive Cap Magnet R2 Photogram R2i3 R2i5 Ball Abutment i-Gen AnyOne Onestage Implant System AnyOne External Implant System Advanced Intermezzo System Dental Light, ML200 Rescue Internal Implant System Rescue External Implant System AnyRidge Octa 1 System BLUEDIAMOND IMPLANT System Abutment Screw BonEx Kit BLUEDIAMOND R2 GUIDE Kit DUO Surgical Kit MegGyver Trial Kit R2 Universal Kit AXA Prosthetic Kit Abutment Selection Guide Kit MILAkit Laboratory Kit AnyRidge Bone Profiler Kit AnyOne Prosthetics Kit R2 ONE2 GUIDE Kit MICAkit Root Membrane Kit AnyGuide R2 Surgical Kit Auto-Max Kit Surgical Kit MegGyver Kit Multi Prosthetic Kit Zygomatic Surgical Kit AnyRidge Surgical Kit PET Kit ZBLC Kit 911 Fixture kit AI Surgical Kit R2 Narrow Kit AnyOne Stopper Drill Kit AnyOne Surgical Kit Short Drill Kit AnyRidge Prosthetic Kit AXA Selection Guide Kit Anchor Kit MUA Selection Guide Kit Universal Kit BLUEDIAMOND Bone Profiler Kit AnyOne Bone Profiler Kit Molar Immediate Solution Kit 911kit Root Membrane Trial Kit MiNi Kit Scan Bar Kit R2 Sinus Kit EZ Seal Kit EZ Seal TiGEN Abutment; PMMA Abutment and Scan Healing Abutment DISC Soft Tissue Harvester R2 Tray Impression Tray N2 (Mount B Type) N2 (Continental Type) N2 (Cart B Type)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility