Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Osstem Implant Co., Ltd.

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

Total Devices31

Categories10

Latest FDA decision2026-03-04

Type	Number	Device Name	Code	Date	Actions
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

Page 2 of 2

↑