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OSSTEM IMPLANT Co., Ltd.

Last updated September 17, 2026

What OSSTEM IMPLANT Co., Ltd. makes

The company manufactures dental implant components, including permanent and temporary preformed suprastructures, reusable and single-use surgical tools like drill bits and screwdrivers, and custom-made ceramic crowns. Their portfolio also includes two-piece endosteal dental implants, implant analogs, and specialized tools such as paranasal sinus trephines and periosteal elevators.

These devices are classified under FDA regulations as Class I and Class II, with listings maintained in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable regulatory standards for dental and surgical instruments.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: osstem.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(821)012-3412
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 689051793

Catalogue (11489)

Page 7 of 230

Device	Model / Reference	Registries	Class	Status
OSSTEM Implant System - Abutment	TSQTA4050MTH	FDA UDI	Class II	Active
OssBuilder System	OBAC400016	FDA UDI	Class II	Active
NoMount Driver	GSNMD32S	FDA UDI	Class I	Active
ET/SS Implant System	SS3R4510S28	FDA UDI	Class II	Active
Osteotome stopper	OST35SH	FDA UDI	Class I	Active
ET US SS Prosthetic system	CAR645N	FDA UDI	Class II	Active
ET US SS Prosthetic system	CAM427NTH	FDA UDI	Class II	Active
Twist Drill	2D2022T	FDA UDI	Class I	Active
Twist Drill	TD1013TL	FDA UDI	Class I	Active
ET Prosthetic System	HGRGA4527SP	FDA UDI	Class II	Active
Ts Fixture System	BTS3M3513S	FDA UDI	Class II	Active
US/SS/GS System	TCAW5647TH	FDA UDI	Class II	Active
OneGuide Implant Driver	HOGFDM50	FDA UDI	Class I	Active
123 Drill Stop	HODST10	FDA UDI	Class I	Active
OssBuilder System	OBAC353016	FDA UDI	Class II	Active
122 Taper Drill	122TPD3510	FDA UDI	Class I	Active
Ts Fixture System	TS3S5013S	FDA UDI	Class II	Active
US/SS/GS System	TPSW100TH	FDA UDI	Class II	Active
OSSTEM Implant System - Abutment	TSMA5010P	FDA UDI	Class II	Active
ET US SS Prosthetic system	OAA500	FDA UDI	Class II	Active
OSSTEM Implant System	TS2S4510S	FDA UDI	Class II	Active
US/SS/GS System	COG600STH	FDA UDI	Class II	Active
Estar-ZE	ZEHTB4012T	FDA UDI	Class II	Active
OneGuide Path Drill	HOGSD3007T	FDA UDI	Class I	Active
HU/HS/HG Prosthetic System	HSHLA483R	FDA UDI	Class II	Active
HS/HG Prosthetic System	HSCOA6004WNW	FDA UDI	Class II	Active
GS System	GSGC600	FDA UDI	Class II	Active
US System	HCR100	FDA UDI	Class II	Active
GS System	GSTA5631	FDA UDI	Class II	Active
HU/HS/HG Prosthetic System	HUCMA50205RHW	FDA UDI	Class II	Active
HU/HS/HG Prosthetic System	HGTFA60405SHW	FDA UDI	Class II	Active
HU/HS/HG Prosthetic System	HGTFA50207SNW	FDA UDI	Class II	Active
US/SS/GS System	GSRA5730P	FDA UDI	Class II	Active
GS System	GSCA6010	FDA UDI	Class II	Active
Hex Driver	OTH12S	FDA UDI	Class I	Active
SideCut Drill	OSLMD20L	FDA UDI	Class I	Active
OSSTEM Implant System - Abutment	GSRRC470	FDA UDI	Class II	Active
Hm Kit	HMISLK	FDA UDI	Class I	Active
SMARTbuilder System	SMHI425USR	FDA UDI	Class II	Active
Estar-Z	ZHTC4022T	FDA UDI	Class II	Active
Ts Fixture System	TS2S5008S	FDA UDI	Class II	Active
123 Twist Drill	2D3041FNS	FDA UDI	Class I	Active
Concave Osteotome	HOST35CA	FDA UDI	Class I	Active
Osstem Abutment System	PTCMC	FDA UDI	Class II	Active
TS Convertible Pick-up Guide Pin	GSCGP400S	FDA UDI	Class I	Active
Estar-Z	ZHTC1016T	FDA UDI	Class II	Active
HySil Impression Materials (Heavy, Mono, and Bite)	ESS380H	FDA UDI	Class II	Active
ET US SS Prosthetic system	NMTR100	FDA UDI	Class II	Active
Bone Compaction Drill	BCD4504	FDA UDI	Class I	Active
OneGuide Metal Sleeve	OGSCN70S	FDA UDI	Class I	Active

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