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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 9 of 10

Device	Model / Reference	Registries	Class	Status
T2	T2-C	EUDAMEDFDA UDI	Class IIb	Active
AutoBone Collector	ABC304L	EUDAMEDFDA UDI	Class IIa	Active
123 Twist Drill	2D3041L	EUDAMEDFDA UDI	Class IIa	Active
OneMS Drill	OMD2708	EUDAMEDFDA UDI	Class IIa	Active
Machine Driver for Denture	MSDMS	EUDAMEDFDA UDI	Class IIa	Active
Expansion Drill	EXP324708	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD6006	EUDAMEDFDA UDI	Class IIa	Active
TS Convertible Pick-up Impression Coping	GSPIC480	EUDAMED	Class I	Active
Twist Drill	TD1013TL	EUDAMEDFDA UDI	Class IIa	Active
Excellent Solid Abutment Driver	ESDSS	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C4005	EUDAMEDFDA UDI	Class IIa	Active
CAS Drill	SNDR3813T	EUDAMEDFDA UDI	Class IIa	Active
Anchor Screw	D4UAS5	EUDAMEDFDA UDI	Class IIa	Active
TS Fixture Transfer Impression Coping	GSTIS4511	EUDAMEDFDA UDI	Class I	Active
SS Scan body	SSSBWTH	EUDAMED	Class I	Active
TS Healing Abutment	TSHA407M	EUDAMEDFDA UDI	Class IIb	Active
TS Fixture Transfer Impression Coping	GSTIS7014	EUDAMEDFDA UDI	Class I	Active
OsstemGuide Twist Drill	QGTD2008	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD3510W	EUDAMEDFDA UDI	Class IIa	Active
Taper Cortical Drill	TCD4C50	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D5504	EUDAMEDFDA UDI	Class IIa	Active
US Fixture Pick-up Impression Coping	ICFR500N	EUDAMEDFDA UDI	Class I	Active
Bone Screw	BSCH1204	EUDAMED	Class IIb	Active
TS Healing Abutment	TSHA403M	EUDAMEDFDA UDI	Class IIb	Active
US Esthetic-low Impression Coping	MSR200	EUDAMEDFDA UDI	Class I	Active
Tissue Punch	OGTP40	EUDAMEDFDA UDI	Class IIa	Active
OneCAS Twist Drill	OCD2210W	EUDAMEDFDA UDI	Class IIa	Active
US Pick-up Guide Pin	GP150	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD4010	EUDAMEDFDA UDI	Class IIa	Active
OneCAS Drill	OCD3310	EUDAMEDFDA UDI	Class IIa	Active
Custom KIT	OCTK	EUDAMEDFDA UDI	Class I	Active
OneMS Drill	OMD2713	EUDAMEDFDA UDI	Class IIa	Active
Trephine Drill	TD37	EUDAMEDFDA UDI	Class IIa	Active
Bone Screw	BSCH1404	EUDAMED	Class IIb	Active
TS Healing Abutment	TSHA407R	EUDAMEDFDA UDI	Class IIb	Active
122 Taper Drill	122TPD4511	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Drill	OSODR150S	EUDAMEDFDA UDI	Class IIa	Active
Positioning Guide Full KIT	HPGAK	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA404M	EUDAMEDFDA UDI	Class IIb	Active
SmartGuide	SGTB85LS	EUDAMEDFDA UDI	Class I	Active
Three Cutter Twist Drill	3D3010LC01	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C4513	EUDAMEDFDA UDI	Class IIa	Active
Expansion Drill	EXP284408	EUDAMEDFDA UDI	Class IIa	Active
Three Cutter Twist Drill	3D3615FNLC01	EUDAMEDFDA UDI	Class IIa	Active
Bone Profiler	GSBP45	EUDAMEDFDA UDI	Class IIa	Active
Parallel Pin	APP500	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA409M	EUDAMEDFDA UDI	Class IIb	Active
Screw Removal Drill	OSRD10L	EUDAMEDFDA UDI	Class IIa	Active
Guide	OGZB01L	EUDAMEDFDA UDI	Class I	Active
Twist Drill	2D1810LC01	EUDAMEDFDA UDI	Class IIa	Active

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Authorities

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FDA Establishments (1)

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

OSSTEM IMPLANT Co., Ltd. US