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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 8 of 10

Device	Model / Reference	Registries	Class	Status
Tissue Punch	OGTP35	EUDAMEDFDA UDI	Class IIa	Active
Torque Extension	OTE	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS01	EUDAMEDFDA UDI	Class I	Active
OsstemGuide Twist Drill	QGTD3810	EUDAMEDFDA UDI	Class IIa	Active
Taper Cortical Drill	TCD4C35	EUDAMEDFDA UDI	Class IIa	Active
Remover Screw	FRSMS33	EUDAMEDFDA UDI	Class I	Active
Bone Screw	BSCH2012	EUDAMED	Class IIb	Active
Locator Torque Driver	TWLDS	EUDAMED	Class I	Active
Bone Screw	BSCH2010	EUDAMED	Class IIb	Active
OneGuide Taper Drill	OGTPD5010W	EUDAMEDFDA UDI	Class IIa	Active
US Pick-up Guide Pin	GP100	EUDAMEDFDA UDI	Class I	Active
Rigid Outer Driver	ORDML	EUDAMEDFDA UDI	Class I	Active
123 Straight Full KIT	O123STFK	EUDAMED	Class IIa	Active
Torque Driver for Torque Wrench	TRHD12MS	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD4513	EUDAMEDFDA UDI	Class IIa	Active
Rigid Outer Driver	ORDRS	EUDAMEDFDA UDI	Class I	Active
Trial Pin	UWFTP62	EUDAMEDFDA UDI	Class I	Active
O-ring Set	OAON02S	EUDAMEDFDA UDI	Class IIb	Active
Trephine Drill	TD37S	EUDAMEDFDA UDI	Class IIa	Active
Ti Abutment Screw	ASM200	EUDAMEDFDA UDI	Class IIb	Active
TS Rigid Impression Coping	GSRIC540S	EUDAMED	Class I	Active
485 Drill	O485D4008	EUDAMEDFDA UDI	Class IIa	Active
Stopper	SNST4	EUDAMEDFDA UDI	Class I	Active
TS Fixture Transfer Impression Coping	GSTIS6014	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD4510	EUDAMEDFDA UDI	Class IIa	Active
Tissue punch	OSTP38	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5007	EUDAMEDFDA UDI	Class IIa	Active
Fixture Driver	GSRFDS	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD4510W	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C4008	EUDAMEDFDA UDI	Class IIa	Active
123 Twist Drill	3D465510T	EUDAMEDFDA UDI	Class IIa	Active
SS Octa Transfer Impression Coping	SSOTI480	EUDAMEDFDA UDI	Class I	Active
Bone Carrier Head	OCBCH37W	EUDAMEDFDA UDI	Class I	Active
Octa Abutment Driver	ODSL	EUDAMEDFDA UDI	Class I	Active
TS Bite Index	GSBIS5512S	EUDAMEDFDA UDI	Class I	Active
Machine Screw Driver	AMSD09L	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD6007	EUDAMEDFDA UDI	Class IIa	Active
Stopper	SNST11	EUDAMEDFDA UDI	Class I	Active
Mount Extension	ASMEL	EUDAMEDFDA UDI	Class I	Active
Twist Drill	TDE2010LC01	EUDAMEDFDA UDI	Class IIa	Active
Locator Torque Driver	TWLDLK	EUDAMEDFDA UDI	Class I	Active
Screw Removal Drill	OSRD09S	EUDAMEDFDA UDI	Class IIa	Active
Fixture Driver	SSRFDL	EUDAMEDFDA UDI	Class I	Active
Twist Drill	2D2218FNLC	EUDAMEDFDA UDI	Class IIa	Active
Trephine Drill	TD52	EUDAMEDFDA UDI	Class IIa	Active
Stopper	SNST5	EUDAMEDFDA UDI	Class I	Active
NoMount Torque Driver	GSNMT32L	EUDAMEDFDA UDI	Class I	Active
Bone Screw	BSCH2014	EUDAMED	Class IIb	Active
Esset Kit	OESEK	EUDAMEDFDA UDI	Class IIa	Active
Three Cutter Twist Drill	3D3013LC01	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