Data / Medical devices / South Korea / Osstem Implant Co., Ltd.

Osstem Implant Co., Ltd.: FDA-registered device maker in Gangseo-gu Seoul, South Korea, 70 510(k) clearances

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

Osstem Implant Co., Ltd. is registered with the FDA (registration 3031886796) in Gangseo-gu Seoul, South Korea. It lists 26 device types. The FDA files 70 510(k) clearances under its listings, the newest dated January 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3031886796
Address: 3, Magokjungang 12-ro, Gangseo-gu Seoul, South Korea, 07789
Owner or operator: Osstem Implant Co., Ltd. (10089729)
Roles: Specification developer
First device listed: January 2, 2024
Registered through: 2026
Brand names listed: 122 Drills, 122 TAPER KIT CASE MIDDLE PLAT, 122 Taper Full Kit, 122 Taper KIT, 123 Drills, 123 KIT, 123 Straight Full KIT, 485 Drills and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Specification developer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Specification developer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Specification developer	accessdata.fda.gov
Bone Grafting Material, Animal Source	NPM	2	Specification developer	accessdata.fda.gov
Bur, Dental	EJL	1	Specification developer	accessdata.fda.gov
Chair, Dental, With Operative Unit	KLC	1	Specification developer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Specification developer	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Specification developer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Specification developer	accessdata.fda.gov
Driver, Band, Orthodontic	ECT	1	Specification developer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Specification developer	accessdata.fda.gov
Fixture Mount Kit	NYE	1	Specification developer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Specification developer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Specification developer	accessdata.fda.gov
Intraoral Camera	QJK	2	Specification developer	accessdata.fda.gov
Material, Impression	ELW	2	Specification developer	accessdata.fda.gov
Needle, Dental	DZM	1	Specification developer	accessdata.fda.gov
Oral Surgery Tray	PWL	1	Specification developer	accessdata.fda.gov
Plate, Bone	JEY	2	Specification developer	accessdata.fda.gov
Powder, Porcelain	EIH	2	Specification developer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Specification developer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Specification developer	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Specification developer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Specification developer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Specification developer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Specification developer	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
January 29, 2026	K251427	EK MULTI ANGLED 30 ABUTMENT	NHA	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
July 17, 2025	K251491	K5 Cart, K5 Mount, K5 Swing	EIA	Substantially Equivalent	Osstem Implant Company., Ltd. Chair Business	accessdata.fda.gov
November 20, 2024	K242521	Estar-ZE	EIH	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 6, 2024	K233806	T2 Plus	OAS	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 3, 2024	K233805	K5	EIA	Substantially Equivalent	Osstem Implant Co., Ltd. Chair Business	accessdata.fda.gov
February 20, 2024	K233194	TS Abutment System	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
December 5, 2023	K232220	SS Abutment System	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 28, 2023	K232012	N1	EHD	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 23, 2023	K222778	Osstem Implant System	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
April 28, 2023	K222636	ET Abutment System	NHA	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
September 8, 2022	K221684	Osstem Abutment System	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 7, 2022	K203360	EK Implants and Abutments System	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
September 21, 2021	K212303	T2	OAS	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
July 2, 2021	K210097	Estar-Z	EIH	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
March 18, 2021	K210041	HySil Plus Impression Materials	ELW	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 30, 2020	K192941	HySil Super Fast Impression Materials	ELW	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
December 16, 2019	K191751	EM Provisional	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
November 15, 2019	K191201	EM SA Implant System	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
September 4, 2019	K183347	K3	EIA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 30, 2019	K183475	T1-CS, T1-C	OAS	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 9, 2019	K182881	Bone Screw, Bone Tack	DZL	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
July 12, 2019	K182091	Osstem Abutment System	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
May 21, 2019	K183242	ET IV SA Dental Implants	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
May 7, 2019	K181854	OssBuilder System	DZL	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 13, 2018	K181236	HySil Impression Materials	ELW	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
March 26, 2018	K172354	OssBuilder System	JEY	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 11, 2018	K170421	ET Hybrid Abutment	NHA	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
June 7, 2017	K170736	HySil Impression Materials	ELW	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
May 22, 2017	K161689	OSSTEM Implant System - Abutment	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
May 15, 2017	K163557	SS SA Fixture	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
April 25, 2017	K160670	ET US SS Prosthetic system	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
April 21, 2017	K163088	TSIII BA Fixture	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
February 2, 2017	K161103	US SA Implant System	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
October 28, 2016	K160519	Link Abutment for CEREC	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
October 27, 2016	K153332	ETIII SA Fixture System (O3.2mm)	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
October 17, 2016	K161604	OSSTEM Implant System	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 3, 2016	K151542	A-Oss	NPM	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
July 21, 2016	K151626	ET III Bio-SA Fixture System	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
November 12, 2014	K140934	HIOSSEN IMPLANT SYSTEM	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
August 21, 2014	K140600	SB ANCHOR	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 20, 2014	K140507	HIOSSEN PROSTHETIC SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 10, 2014	K130662	ET PROSTHETIC SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
December 20, 2013	K132067	MULTI ANGLED ABUTMENT SYSTEM	NHA	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
September 18, 2013	K130840	SMARTBUILDER SYSTEM (SB1)	JEY	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
July 5, 2013	K123471	ETII SA FIXTURE SYSTEM	DZE	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
June 28, 2013	K123627	ET SMARTFIT ABUTMENT	NHA	Substantially Equivalent	Hiossen, Inc.	accessdata.fda.gov
April 26, 2013	K123755	MULTI ANGLED ABUTMENT	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 7, 2013	K121585	TS IMPLANT SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
December 11, 2012	K121843	NP-CAST ABUTMENT SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 29, 2012	K121995	TS FIXTURE SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 16, 2012	K122171	MS SA IMPLANT SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
October 3, 2012	K120951	SMARTBUILDER SYSTEM	JEY	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 10, 2012	K120847	ET/SS IMPLANT SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
October 3, 2011	K110308	PROSTHETIC SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
March 25, 2011	K103105	ORTHODONTIC SCREW	OAT	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 17, 2010	K100245	HS/HG PROSTHETIC SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
March 3, 2010	K091208	GS III SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
February 18, 2010	K091678	HG II SHORT FIXTURE SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
December 2, 2008	K081786	ZIOCERA & CONVERTIBLE SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 3, 2008	K080594	MS SYSTEM (NARROW RIDGE)	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 2, 2008	K081575	HU/HS/HG PROSTHETIC SYSTEM	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
July 17, 2008	K080744	HG II FIXTURE SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
March 7, 2008	K073247	US/SS/GS SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
January 10, 2008	K072871	MS SYSTEM (PROVISIONAL)	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 6, 2007	K072896	GS FIXTURE SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 21, 2007	K063861	GS SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 2, 2006	K062030	US SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
November 1, 2006	K062051	SS SYSTEM	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
October 20, 2006	K062156	SUPER ORTHODONTIC SCREW	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 1, 2005	K051576	AVANA DENTAL IMPLANT SYSTEM	DZE	Substantially Equivalent	Osstem Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 29, 2026. 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.