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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 10 of 10

Device	Model / Reference	Registries	Class	Status
OsstemGuide Twist Drill	QGTD2010	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD3511W	EUDAMEDFDA UDI	Class IIa	Active
L-Wrench	LWC	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD7011	EUDAMEDFDA UDI	Class IIa	Active
Removal Tool for Fixture Mount	HRFR	EUDAMEDFDA UDI	Class I	Active
Twist Drill	OSMSD18L	EUDAMEDFDA UDI	Class IIa	Active
TS Scan Healing Abutment	TSSHA454RTH	EUDAMEDFDA UDI	Class IIb	Active
122 Taper Drill	122TPD7008	EUDAMEDFDA UDI	Class IIa	Active
Remover Screw	FRSRA40F	EUDAMEDFDA UDI	Class I	Active
CAS Drill	SNDR3113TL	EUDAMEDFDA UDI	Class IIa	Active
Bone Carrier Head	SNBCH35	EUDAMEDFDA UDI	Class I	Active
Stopper	ABC2ST604S	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C6011	EUDAMEDFDA UDI	Class IIa	Active
Abutment Removal Tip	OARTMS	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C6006	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D4006	EUDAMEDFDA UDI	Class IIa	Active
TS Bite Index	GSBIS5510S	EUDAMEDFDA UDI	Class I	Active
OneGuide Twist Drill	OGTD2211	EUDAMEDFDA UDI	Class IIa	Active
OneCAS Drill	OCD3110	EUDAMEDFDA UDI	Class IIa	Active
AutoBone Collector	ABC304S	EUDAMEDFDA UDI	Class IIa	Active
EXP Mount Driver	AESMDL	EUDAMEDFDA UDI	Class IIa	Active
Trephine Drill	TD42S	EUDAMEDFDA UDI	Class IIa	Active
Remover Body	FRBR40L	EUDAMEDFDA UDI	Class I	Active
OneMS Drill	OMD1511	EUDAMEDFDA UDI	Class IIa	Active
TS Fixture Transfer Impression Coping	GSTIS6014N	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA456M	EUDAMED	Class IIb	Active
OneMS Drill	OMD2311	EUDAMEDFDA UDI	Class IIa	Active
TS Pick-up Guide Pin	GSPGPR150	EUDAMED	Class I	Active
Taper Drill	TPD3C5510	EUDAMEDFDA UDI	Class IIa	Active
Bone Profiler	GSBP55	EUDAMED	Class IIa	Active
Torque wrench	TW30B	EUDAMEDFDA UDI	Class I	Active
SS Excellent Solid Impression Coping	SSEIC607	EUDAMEDFDA UDI	Class I	Active
KS Scan body (Intraoral)	KSNSBSTH	EUDAMED	Class I	Active
TS Healing Abutment	TSHA459M	EUDAMEDFDA UDI	Class IIb	Active
TS Scan Healing Abutment	TSSHA607RTH	EUDAMEDFDA UDI	Class IIb	Active
CAS Drill	SNDR4113TL	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA406R	EUDAMED	Class IIb	Active
TS Fixture Transfer Impression Coping	GSTIS7014N	EUDAMEDFDA UDI	Class I	Active
TS Fixture Transfer Impression Coping	GSTIS6011	EUDAMEDFDA UDI	Class I	Active
Twist Drill	SNTD2213TL	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD4507	EUDAMEDFDA UDI	Class IIa	Active
SideCut Drill	OSLMDS	EUDAMEDFDA UDI	Class IIa	Active
Remover Body	FRBR40S	EUDAMEDFDA UDI	Class I	Active
Hand Driver	AHD12SH	EUDAMEDFDA UDI	Class I	Active
Hand Driver	AHD09SH	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C3511	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5006	EUDAMEDFDA UDI	Class IIa	Active
Expansion Drill	EXP223608	EUDAMEDFDA UDI	Class IIa	Active
Stopper	OCDS08	EUDAMEDFDA UDI	Class I	Active
TS Bite Index	GSBIM4510S	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