Osstem Implant Co., Ltd.

FDA 510(k) & PMA Approved Devices — 31 products

Total Devices31

Categories10

Latest Approval2026-03-04

Type	Number	Device Name	Code	Date
510(k)	K251434	Healing Abutment System	NHA	2026-03-04	View
510(k)	K251569	Bone Screw	DZL	2025-08-13	View
510(k)	K242521	Estar-ZE	EIH	2024-11-20	View
510(k)	K233806	T2 Plus	OAS	2024-09-06	View
510(k)	K233194	TS Abutment System	NHA	2024-02-20	View
510(k)	K232220	SS Abutment System	NHA	2023-12-05	View
510(k)	K232012	N1	EHD	2023-11-28	View
510(k)	K222778	Osstem Implant System	DZE	2023-09-23	View
510(k)	K221684	Osstem Abutment System	NHA	2022-09-08	View
510(k)	K212303	T2	OAS	2021-09-21	View
510(k)	K210097	Estar-Z	EIH	2021-07-02	View
510(k)	K210041	HySil Plus Impression Materials	ELW	2021-03-18	View
510(k)	K192941	HySil Super Fast Impression Materials	ELW	2020-01-30	View
510(k)	K183347	K3	EIA	2019-09-04	View
510(k)	K183475	T1-CS, T1-C	OAS	2019-08-30	View
510(k)	K182881	Bone Screw, Bone Tack	DZL	2019-08-09	View
510(k)	K182091	Osstem Abutment System	NHA	2019-07-12	View
510(k)	K181854	OssBuilder System	DZL	2019-05-07	View
510(k)	K181236	HySil Impression Materials	ELW	2018-09-13	View
510(k)	K172354	OssBuilder System	JEY	2018-03-26	View
510(k)	K170736	HySil Impression Materials	ELW	2017-06-07	View
510(k)	K161689	OSSTEM Implant System - Abutment	NHA	2017-05-22	View
510(k)	K163557	SS SA Fixture	DZE	2017-05-15	View
510(k)	K160670	ET US SS Prosthetic system	NHA	2017-04-25	View
510(k)	K163088	TSIII BA Fixture	DZE	2017-04-21	View
510(k)	K152830	K3	EIA	2017-04-20	View
510(k)	K161103	US SA Implant System	DZE	2017-02-02	View
510(k)	K161197	Orthodontic Screw	OAT	2016-12-21	View
510(k)	K153015	Transfer & Angled Abutment	NHA	2016-12-05	View
510(k)	K160519	Link Abutment for CEREC	NHA	2016-10-28	View
510(k)	K161604	OSSTEM Implant System	DZE	2016-10-17	View