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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 4 of 10

Device	Model / Reference	Registries	Class	Status
Stopper	LSNST2.0	EUDAMEDFDA UDI	Class I	Active
OssBuilder KIT	HGBRK	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD3511	EUDAMEDFDA UDI	Class IIa	Active
Reverse Driver	ORVDRS	EUDAMEDFDA UDI	Class I	Active
Remover Screw	FRSRS41F	EUDAMEDFDA UDI	Class I	Active
Solid Abutment Driver	SDSS	EUDAMEDFDA UDI	Class I	Active
Screw Holder	OSHM	EUDAMEDFDA UDI	Class I	Active
TS Scan Healing Abutment Carrier	TSSHAC600L	EUDAMEDFDA UDI	Class I	Active
Remover Body	FRBM35L	EUDAMEDFDA UDI	Class I	Active
Single Guide	SGB060	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD6010	EUDAMEDFDA UDI	Class IIa	Active
Torque Wrench	TW400B	EUDAMEDFDA UDI	Class I	Active
TS Fixture Transfer Impression Coping	GSTIS4014N	EUDAMEDFDA UDI	Class I	Active
TS Rigid Impression Coping	GSRIC670S	EUDAMED	Class I	Active
Freer Elevator	OFE	EUDAMEDFDA UDI	Class I	Active
Bone Screw Machine Driver	BSCMD	EUDAMEDFDA UDI	Class IIa	Active
123 Twist Drill	2D223006LC	EUDAMED	Class IIa	Active
OsstemGuide Twist Drill	QGTD2013	EUDAMEDFDA UDI	Class IIa	Active
Guide Drill	AGDLC	EUDAMEDFDA UDI	Class IIa	Active
Excellent Solid Abutment Driver	ESDSL	EUDAMEDFDA UDI	Class I	Active
Taper Drill	TPD3C4508	EUDAMEDFDA UDI	Class IIa	Active
Bone Tack Holder	OBTH	EUDAMEDFDA UDI	Class I	Active
Easy Screw Removal KIT	OESRK	EUDAMED	Class IIa	Active
TS Scan Healing Abutment	TSSHA504RTH	EUDAMEDFDA UDI	Class IIb	Active
CAS Drill	SNDR3613T	EUDAMEDFDA UDI	Class IIa	Active
Orthodontic Drill	OSODR100S	EUDAMEDFDA UDI	Class IIa	Active
TS Scan Healing Abutment	TSSHA605RTH	EUDAMEDFDA UDI	Class IIb	Active
NoMount Torque Driver	GSNMT32E	EUDAMEDFDA UDI	Class I	Active
Trephine Drill	TD62S	EUDAMEDFDA UDI	Class IIa	Active
Fixture Driver	OGFDR57	EUDAMED	Class I	Active
Depth Gauge	ADG	EUDAMEDFDA UDI	Class I	Active
Cover Cap	SMCC415	EUDAMEDFDA UDI	Class IIb	Active
CAS Drill	SNDR3613TL	EUDAMEDFDA UDI	Class IIa	Active
Repair Torque Driver For Torque Wrench	TRHD12LR	EUDAMEDFDA UDI	Class I	Active
TS Pick-up Guide Pin	GSPGPM200L	EUDAMED	Class I	Active
Screw Driver	FRSDW30	EUDAMEDFDA UDI	Class I	Active
TS Scan Healing Abutment	TSSHA604RTH	EUDAMEDFDA UDI	Class IIb	Active
Depth Gauge	OCDG	EUDAMEDFDA UDI	Class I	Active
NoMount Driver	OGNMDM50	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD5007W	EUDAMEDFDA UDI	Class IIa	Active
OneMS Drill	OMD1808	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA605R	EUDAMEDFDA UDI	Class IIb	Active
CAS Drill	SNDR3313TS	EUDAMEDFDA UDI	Class IIa	Active
Tissue punch	OSTP53	EUDAMEDFDA UDI	Class IIa	Active
Stopper	ABC2ST404S	EUDAMEDFDA UDI	Class I	Active
Remover Screw	FRSMS33F	EUDAMEDFDA UDI	Class I	Active
Crest Remover	CERM50S	EUDAMEDFDA UDI	Class IIa	Active
Taper Fixture Surgical Tap	OFTS50	EUDAMEDFDA UDI	Class IIa	Active
Ms Parallel Pin	MSPP	EUDAMEDFDA UDI	Class I	Active
Positioning Guide Full KIT	OPGAK	EUDAMEDFDA UDI	Class IIa	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