Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089804

FEI Number

3030089804

Entity Name

MegaGen Implant Co., Ltd. (Secheon 2nd factory)

City/State/Country

Daegu, KR

Establishment Address

17-18, 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

K211556

PMA Number

N/A

All Registered Proprietary Names

N2 (Mount B Type) N2 (Continental Type) N2 (Cart B Type) Dental Light, ML200 2nd Assi N2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2024-03-25
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2023-04-21
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2019-06-18
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2023-04-06

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
3005554774	Megagen Implant Co., Ltd.	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

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3008344699	SHANGHAI FIMET MEDICAL INSTRUMENT CO., LTD.	Shang hai Shanghai, CN
3005082946	HALLIM POINT IMPLANT CO., LTD	SIHEUNG-SI Gyeonggi, KR
2520265	DENTALEZ, INC., STARDENTAL DIVISION	Lancaster, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030089804. Last updated year: 2026. Please use registration number 3030089804 when referencing this establishment in official correspondence.