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
- [email protected]
- Phone
- 714 9225276
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2015-06-10 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2015-06-10 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2010-04-15 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2008-11-25 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2024-04-02 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2022-12-12 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2019-09-15 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2005-03-22 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2014-09-11 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2008-10-28 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2022-06-29 |
| Evacuator, Oral Cavity | EHZ | Class 1 | Dental | No | 2020-06-09 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2010-04-15 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2022-08-24 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2025-11-30 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2012-05-21 |
| Fixture Mount Kit | NYE | Class 1 | Dental | No | 2025-08-28 |
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