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Megagen Implant Co., Ltd. (Seoul Branch)

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

22listed device types

Class I 15Class II 7Class III 0

plus 96 registration records and 32 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

23 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States96 registration records, 32 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: MegaGen Implant Co., Ltd. (Research Laboratories) · Megagen Implant Co., Ltd. · MegaGen Implant Co., Ltd. (Secheon 2nd factory) · Megagen Implant Co., Ltd. (Seoul Branch) · MEGAGEN IMPLANT CO., LTD. · MegaGen Implant Co., Ltd.

Same-named companies — This database also contains companies with near-identical names: Megagen Implant Co., Ltd., MegaGen Implant Co., Ltd. (Research Laboratories). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12008

12010

22012

32013

12014

12015

42019

12020

32021

32022

62023

42024

12025

12026

FDA listed device types

showing 8 of 22

Attachment, Precision, All 1Chair, Surgical, Ac-Powered 1Knife, Periodontic 1Bur, Dental 1Evacuator, Oral Cavity 1Unit, Operative Dental 1Light, Operating, Dental 1Tray, Impression, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251232	MegaGen Zygoma Dental Implant System	2026-06-18
US	K242030	MegaGen Dental Implant Abutment	2025-01-13
US	K241972	BLUEDIAMOND IMPLANT	2024-12-27
SA	ME0000005461SFDAA00042	EZ Seal Kit	—
SA	ME0000005461SFDAA00042	EZ Seal Kit	—

Megagen Implant Co., Ltd. (Seoul Branch)

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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