Data / Medical devices / South Korea / KJ Meditech Co., Ltd.

KJ Meditech Co., Ltd.: FDA-registered device maker in Gwangju, South Korea, 18 510(k) clearances

Name: KJ Meditech Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

KJ Meditech Co., Ltd. is registered with the FDA (registration 3008959419) in Gwangju, South Korea. It lists 4 device types. The FDA files 18 510(k) clearances under its listings, the newest dated March 1, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008959419
Address: 21, Cheomdan venture-ro 40 beon-gil, Buk-gu, Gwangju, South Korea, 61009
Owner or operator: KJ Meditech Co., Ltd. (10035757)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: March 22, 2011
Registered through: 2026
Brand names listed: Anchor plus, Conical Plus Implant System, Dental Implant Analog, Dental Implant Attachment Components, Dental Implant Comfort Cap, Dental Implant Drivers, Dental Implant Impression Components, Dental Implant Removal and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Contract sterilizer, Manufacturer	accessdata.fda.gov
Headgear, Extraoral, Orthodontic	DZB	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 1, 2022	K202046	LOTA SLA Dental Implant System and LOTA HA Dental Implant System	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
June 28, 2018	K173116	KJ ZIRCONIA Implant System	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
November 9, 2017	K161923	J2A SLA Dental Implant System	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
October 21, 2016	K151970	KJ Mini Implant System	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
April 2, 2015	K150060	J2A Dental Implant System, J2C Dental Implant System	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
October 30, 2014	K140052	J2I IMPLANT SYSTEM	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
October 30, 2014	K140051	KJ EXTERNAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
September 19, 2014	K133050	ONE PLUS IMPLANT SYSTEM	DZE	Substantially Equivalent	Osseofuse, Inc.	accessdata.fda.gov
June 19, 2014	K130694	JR IMPLANT SYSTEM	DZE	Substantially Equivalent	LK Consulting Group USA, Inc.	accessdata.fda.gov
March 21, 2014	K132144	KERATOR	DZE	Substantially Equivalent	LK Consulting Group USA, Inc.	accessdata.fda.gov
October 31, 2013	K131748	OSSEOFUSE DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Osseofuse, Inc.	accessdata.fda.gov
January 17, 2013	K121098	HERO I DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
October 4, 2012	K121047	HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
August 8, 2012	K112787	KERATOR	NHA	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
September 14, 2011	K103810	KJ SUBMERGED SYSTEM	DZE	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
July 14, 2011	K110577	OSSEOFUSE DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Dynamic Innovations, Inc.	accessdata.fda.gov
June 9, 2011	K103019	KJ MASK	DZB	Substantially Equivalent	Kj Meditech Co., Ltd.	accessdata.fda.gov
May 31, 2006	K053629	ANCHOR PLUS/NEO ANCHOR PLUS	DZE	Substantially Equivalent	Kj Meditech	accessdata.fda.gov

Compare with other makers

Updated March 1, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.