Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007663058

FEI Number

3007663058

Entity Name

META SYSTEMS CO., LTD also doing business as S-Denti Co.,Ltd

City/State/Country

Seongnam-si Gyeonggi, KR

Establishment Address

#1214-18, Sicox tower 12F, 484, Dunchon-daero, Jungwon-gu, Seongnam-si Gyeonggi 13229, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Meta Biomed, Inc (Owner Number: 10029431)

Owner / Operator Contact Address

3015 ADVANCE LANE, Colmar, PA 18915, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210789

PMA Number

N/A

All Registered Proprietary Names

GUTTA PERCHA CARTRIDGE EQ-M i-ROOT 100 mini EQ-S EQ-PEX

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EKM	Gutta-Percha	Dental	Class 1	872.3850	2015-10-28
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2025-11-15
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2022-09-22
LQY	Locator, Root Apex	Unknown	Class U	N/A	2022-09-22
LQY	Locator, Root Apex	Unknown	Class U	N/A	2012-09-14
JET	Pick, Massaging	Dental	Class 1	872.6650	2018-07-30
LQY	Locator, Root Apex	Unknown	Class U	N/A	2021-10-20

Official Correspondent

Ian Yun

US Agent Details

Ian Yun Business: META BIOMED, INC Email: metabiomed@gmail.com Phone: (267) 2825893

Related Public Records

Same Entity

Meta Biomed, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007301326	Meta Biomed, Inc.	Colmar, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243921	Foshan Coxo Medical Instrument Co., Ltd.	LED Curing Lights (DB686 HALO)	2025-04-11
K033201	Apoza Enterprise Co., Ltd.	LA500 BLUE LIGHT	2003-12-02
K241065	Dentis Co., Ltd.	ChecQ (AC100)	2025-03-21
K821629	Moyco Industries, Inc.	FIXIDENT	1982-06-14

Similar Registrations

Registration Number	Establishment Name	Location
3004133229	TIANJIN DIADENT CO., LTD.	TIANJIN CITY, CN
3043750057	JIANGSU YIDA MEDICAL EQUIPMENT CO., LTD	Yancheng Jiangsu, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3005831677	B&L BIOTECH CO., INC	Ansan City Gyeonggi, KR
3042866301	HSG-S CORP	Savannah, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007663058. Last updated year: 2026. Please use registration number 3007663058 when referencing this establishment in official correspondence.