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

Osstem Implant Co., Ltd.: FDA-registered device maker in Haeundae-gu Busan, South Korea, 43 510(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 3003394081) in Haeundae-gu Busan, South Korea. It lists 16 device types. The FDA files 43 510(k) clearances under its listings, the newest dated March 4, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Osstem Implant Co., Ltd.

FDA registration number: 3003394081
Address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu Busan, South Korea, 48002
Owner or operator: OSSTEM IMPLANT CO LTD (9062743)
Roles: Complaint file establishment, Contract manufacturer, Exporter to the US, Manufacturer
First device listed: July 18, 2006
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	Complaint file establishment, Contract manufacturer, Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Accessories, Retractor, Dental	EIF	1	Manufacturer	accessdata.fda.gov
Bur, Dental	EJL	1	Manufacturer	accessdata.fda.gov
Curette, Surgical, Dental	EMK	1	Manufacturer	accessdata.fda.gov
Drill, Dental, Intraoral	DZA	1	Manufacturer	accessdata.fda.gov
Driver, Band, Orthodontic	ECT	1	Manufacturer	accessdata.fda.gov
Elevator, Surgical, Dental	EMJ	1	Manufacturer	accessdata.fda.gov
Fixture Mount Kit	NYE	1	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Orthodontic	OAT	2	Manufacturer	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Manufacturer	accessdata.fda.gov
Needle, Dental	DZM	1	Manufacturer	accessdata.fda.gov
Oral Surgery Tray	PWL	1	Exporter to the US	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer	accessdata.fda.gov
Scaler, Periodontic	EMN	1	Manufacturer	accessdata.fda.gov
Screw, Fixation, Intraosseous	DZL	2	Complaint file establishment, 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 4, 2026	K251434	Healing Abutment System	NHA	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
August 13, 2025	K251569	Bone Screw	DZL	Substantially Equivalent	Osstem Implant Co., Ltd.	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
September 23, 2023	K222778	Osstem Implant System	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 8, 2022	K221684	Osstem Abutment System	NHA	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 7, 2019	K181854	OssBuilder System	DZL	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
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
December 21, 2016	K161197	Orthodontic Screw	OAT	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 17, 2016	K161604	OSSTEM Implant System	DZE	Substantially Equivalent	Osstem Implant Co., Ltd.	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
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
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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 26, 2025	97869	Class II	Ongoing	Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.	Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product co	accessdata.fda.gov

Compare with other makers

Updated March 4, 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.