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OSSTEM IMPLANT CO., LTD.

South Korea·KR-MF-000020006

Last updated September 17, 2026

Information

Country: South Korea
Address: 51, Mayu-ro 238beon-gil, Siheung-si, Gyeonggi-do,15079, Republic of Korea, Siheung-si, South Korea
Website: osstem.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Heekwon Son
EUDAMED SRN: KR-MF-000020006
FDA FEI Number: 3031886796
DUNS Number: —

Catalogue (500)

Page 7 of 10

Device	Model / Reference	Registries	Class	Status
Long Shank Pilot Drill	APD300C	EUDAMEDFDA UDI	Class IIa	Active
Mount Driver	ASMDS	EUDAMEDFDA UDI	Class IIa	Active
Remover Screw	FRSRS41	EUDAMEDFDA UDI	Class I	Active
Guide	OGNR02L	EUDAMEDFDA UDI	Class I	Active
Cortical Drill	CD4C70	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA409M	EUDAMEDFDA UDI	Class IIb	Active
Screw Removal Drill	OSRD09L	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD3511	EUDAMEDFDA UDI	Class IIa	Active
Re-tap	ORTM	EUDAMEDFDA UDI	Class I	Active
Machine Screw Driver	EIHD27	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5008	EUDAMEDFDA UDI	Class IIa	Active
TS NoMount Driver	TSNMDRE	EUDAMEDFDA UDI	Class IIa	Active
Reverse Drill	ARVDMLC	EUDAMEDFDA UDI	Class IIa	Active
Taper Fixture Surgical Tap	OFTS45	EUDAMEDFDA UDI	Class IIa	Active
Screw Removal Drill	OSRD08S	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD4508	EUDAMEDFDA UDI	Class IIa	Active
Parallel Pin	APP400	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD4508W	EUDAMEDFDA UDI	Class IIa	Active
Twist Drill	3D4618FNLC	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D3504	EUDAMEDFDA UDI	Class IIa	Active
US Fixture Pick-up Impression Coping	ICSR500	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C6010	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA457R	EUDAMEDFDA UDI	Class IIb	Active
Stopper	OCDS03	EUDAMEDFDA UDI	Class I	Active
Hand Driver	AHD09LH	EUDAMEDFDA UDI	Class I	Active
TS Pick-up Guide Pin	GSPGPM150	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C5007	EUDAMEDFDA UDI	Class IIa	Active
Cortical Drill 3	CD4C50	EUDAMEDFDA UDI	Class IIa	Active
Torque Handle	TQHD	EUDAMEDFDA UDI	Class I	Active
Taper Cortical Drill	TCD4C45	EUDAMEDFDA UDI	Class IIa	Active
Expansion Drill	EXP284411	EUDAMEDFDA UDI	Class IIa	Active
SideCut Drill	OSLMD20S	EUDAMEDFDA UDI	Class IIa	Active
TS Rigid Impression Coping	GSRIC441S	EUDAMED	Class I	Active
OneCAS Drill	OCD3307	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5515	EUDAMEDFDA UDI	Class IIa	Active
Ms Kit	OMSK	EUDAMEDFDA UDI	Class IIa	Active
Abutment Positioning Driver	OAPDS	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS02W	EUDAMEDFDA UDI	Class I	Active
OneGuide Path Drill	OGSD2507	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD3507	EUDAMEDFDA UDI	Class IIa	Active
SS Octa Pick-up Impression Coping	SSICN600	EUDAMEDFDA UDI	Class I	Active
Positioning Guide KIT	HPGPK	EUDAMEDFDA UDI	Class IIa	Active
Bone Spreader	SNBS2015T	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C4510	EUDAMEDFDA UDI	Class IIa	Active
Ms Implant (provisional)	MST18084	EUDAMED	Class IIb	Active
Machine Driver for Narrow Ridge	MSPMS	EUDAMEDFDA UDI	Class IIa	Active
Guide	OGTML	EUDAMEDFDA UDI	Class I	Active
CAS Drill	SNDR3313T	EUDAMEDFDA UDI	Class IIa	Active
OsstemGuide Sleeve	QGS48M	EUDAMEDFDA UDI	Class I	Active
Torque Wrench	TW30	EUDAMEDFDA UDI	Class I	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

OSSTEM IMPLANT Co., Ltd. US