Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005554774

FEI Number

3005554774

Entity Name

Megagen Implant Co., Ltd.

City/State/Country

Daegu, KR

Establishment Address

45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu 42921, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MEGAGEN IMPLANT CO. LTD (Owner Number: 9067358)

Owner / Operator Contact Address

45, Secheon-ro 7-gil, Dasa-eup, Dalseong-gun, Daegu, KR-NOTA 42921, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053353

PMA Number

N/A

All Registered 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 MegaGen Dental Implant Abutment ARi ExCon Implant System Multi-unit Abutment, Multi-unit Angled Abutment Abutment Screw BLUEDIAMOND IMPLANT 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 TiGEN Abutment Scan Healing Abutment ZrGEN Abutment Core Lifter 1 Core Lifter 2 XPEED AnyRidge Internal Implant System AnyRidge Octa 1 System BLUEDIAMOND IMPLANT System Rescue Internal Implant System DISC Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment TiGEN Abutment ZrGEN Abutment AnyRidge Internal Implant System EZ Plus Implant System Exfeel Implant System Rescue Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-06-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-06-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-01-31
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-11-14
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-11-14
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-11-13
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2010-04-15
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2008-11-25
NOF	System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	Dental	Class 2	872.3661	2024-04-02
OAS	X-Ray, Tomography, Computed, Dental	Radiology	Class 2	892.1750	2022-12-12
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-01-19
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2019-09-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-04-01
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-10-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-01-24
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-12-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-12-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-11-08
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-01-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-01-10
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2005-03-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-09-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-09-10
JEY	Plate, Bone	Dental	Class 2	872.4760	2014-09-11
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2022-11-28
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2008-10-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-06-10
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-10-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2019-10-29
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2008-11-19
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-11-19
EJL	Bur, Dental	Dental	Class 1	872.3240	2022-06-29
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-03-02
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2011-12-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2011-12-01
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2008-11-19
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2006-04-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2006-04-13

Official Correspondent

Kwang Bum Park

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

MEGAGEN IMPLANT CO. LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025029560	Megagen Implant Co., Ltd. (Seoul Branch)	Seoul, KR
3030089804	MegaGen Implant Co., Ltd. (Secheon 2nd factory)	Daegu, KR
3030089802	MegaGen Implant Co., Ltd. (Research Laboratories)	Daegu, KR
2027755	BIOLASE MG LLC	Foothill Ranch, CA, US
3017125161	BIOLASE MG LLC	Corona, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005554774. Last updated year: 2026. Please use registration number 3005554774 when referencing this establishment in official correspondence.