FDA Registration Active 🇰🇷 South Korea

Megagen Implant Co., Ltd.

Reg #: 3005554774 · FEI: 3005554774 · Expires 2026
Products
17
Proprietary Names
227
Establishment Types
4
Classifications
17

Registration Details

Registration Name
Megagen Implant Co., Ltd.
Registration Number
3005554774
FEI Number
3005554774
Status
Active
Expiry Year
2026
Initial Importer
No
Address
45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun
City
Daegu
Country
KR

Regulatory Submissions

510(k) Number
K122231

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
Phone
714 9225276

Products

Device Name Product Code
Implant, Endosseous, Root-Form DZE
Abutment, Implant, Dental, Endosseous NHA
Tray, Impression, Preformed EHY
Drill, Dental, Intraoral DZA
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF
X-Ray, Tomography, Computed, Dental OAS
Attachment, Precision, All EGG
Accessories, Implant, Dental, Endosseous NDP
Plate, Bone JEY
Elevator, Surgical, Dental EMJ
Bur, Dental EJL
Evacuator, Oral Cavity EHZ
Knife, Periodontic EMO
Toothbrush, Manual EFW
Powder, Porcelain EIH
Instrument, Filling, Plastic, Dental EIY
Fixture Mount Kit NYE

Proprietary Names

XPEED AnyRidge Internal Implant System MegaGen Dental Implant Abutment ST Internal Implant System Intermezzo Implant System R2 Tray Impression Tray 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 R2 Photogram R2i3 R2i5 RCT820-SC RCT820 R2 STUDIO Q BLUEDIAMOND IMPLANT Retentive Cap Magnet Ball Abutment Advanced Intermezzo System ARi ExCon Implant System Multi-unit Abutment, Multi-unit Angled Abutment Abutment Screw N2C 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 AnyOne Internal Implant System TiGEN Abutment i-Gen Scan Healing Abutment ZrGEN Abutment Core Lifter 1 Core Lifter 2 AnyRidge Octa 1 System BLUEDIAMOND IMPLANT System Rescue Internal Implant System DISC Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment AnyRidge Internal Implant System EZ Plus Implant System Exfeel Implant System Rescue Implant System Dr. Vortex Soft Tissue Harvester Standard toothbrush - black Standard toothbrush - white Standard toothbrush - grey Wide toothbrush Toothbrush HU-EN Regular toothbrush, Slim toothbrush Cover Screw Healing Abutment AnyOne External Implant System MiNi Internal Implant System AnyOne Onestage Implant System MegaGen Dental Implant Systems Portfolio Rescue External Implant System TiGEN Abutment; PMMA Abutment and Scan Healing Abutment R2iCE II EZ Seal Kit EZ Seal 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

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device