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

Osstem Implant Co.,ltd.: FDA-registered device maker in Yeonsu-gu Incheon, South Korea, 8 510(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 3045816948) in Yeonsu-gu Incheon, South Korea. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated July 17, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3045816948
Address: 104 Cheomdan-daero, Yeonsu-gu Incheon, South Korea, 21989
Owner or operator: Osstem Implant Co.,Ltd. (10095871)
Roles: Exporter to the US, Foreign private label distributor, Manufacturer
First device listed: May 13, 2026
Registered through: 2026
Brand names listed: K3, K3-Chair only, K5, K5 Cart, K5 Mount, K5 Swing, N1, S2 (digital intra-oral X-ray sensor), T1 C, T1-CS, T2 (T2-C, T2-CS) and more

Devices it lists

Device	Product code	Class	Role	Source
Chair, Dental, With Operative Unit	KLC	1	Manufacturer	accessdata.fda.gov
Chair, Dental, Without Operative Unit	NRU	1	Manufacturer	accessdata.fda.gov
Unit, Operative Dental	EIA	1	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Intraoral	EAP	2	Exporter to the US, Foreign private label distributor	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	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
July 17, 2025	K251491	K5 Cart, K5 Mount, K5 Swing	EIA	Substantially Equivalent	Osstem Implant Company., Ltd. Chair Business	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
November 28, 2023	K232012	N1	EHD	Substantially Equivalent	Osstem Implant Co., Ltd.	accessdata.fda.gov
September 21, 2021	K212303	T2	OAS	Substantially Equivalent	Osstem Implant Co., Ltd.	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
April 19, 1995	K950532	TROPHY RADIOLOGIE RVG PORTABLE RADIOVISIOGRAPHY	EAP	Substantially Equivalent	Trophy Radiologie	accessdata.fda.gov

Compare with other makers

Updated July 17, 2025. 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.