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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 6 of 10

Device	Model / Reference	Registries	Class	Status
Reverse Drill	ARVDRLC	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Twist Drill	OGTD2213	EUDAMEDFDA UDI	Class IIa	Active
Flattening Drill	OGFD45	EUDAMEDFDA UDI	Class IIa	Active
Denture Guide	PGODA	EUDAMEDFDA UDI	Class I	Active
Orthodontic Screw Hand Driver	OSTDA	EUDAMEDFDA UDI	Class I	Active
OneCAS Drill	OCD2807W	EUDAMEDFDA UDI	Class IIa	Active
Bone Screw	BSCH1406	EUDAMED	Class IIb	Active
Three Cutter Twist Drill	3D2715FNLC01	EUDAMEDFDA UDI	Class IIa	Active
Screw Driver	FRSDR25	EUDAMEDFDA UDI	Class I	Active
OneMS KIT	HOMSK	EUDAMEDFDA UDI	Class IIa	Active
Bone Mill	ABM	EUDAMEDFDA UDI	Class I	Active
OsstemGuide Twist Drill	QGTD2011	EUDAMEDFDA UDI	Class IIa	Active
Tissue punch	OSTP43	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD4506	EUDAMEDFDA UDI	Class IIa	Active
Stopper	ODST07	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA406R	EUDAMED	Class IIb	Active
OneGuide Taper Drill	OGTPD5511W	EUDAMEDFDA UDI	Class IIa	Active
TS Scan Healing Abutment	TSSHA455RTH	EUDAMEDFDA UDI	Class IIb	Active
122 Taper Kit	H122TPK	EUDAMED	Class IIa	Active
Trephine Drill	TD47	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA704R	EUDAMEDFDA UDI	Class IIb	Active
Remover Screw	FRSW50F	EUDAMEDFDA UDI	Class I	Active
SS Excellent Solid Impression Coping	SSEIC605	EUDAMEDFDA UDI	Class I	Active
Screw Removal Tip	ORT16S	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD4508	EUDAMEDFDA UDI	Class IIa	Active
TS Bite Index	GSBIM4508S	EUDAMEDFDA UDI	Class I	Active
TS Rigid Impression Coping	GSRIC461S	EUDAMED	Class I	Active
Taper Drill	TPD3C3510	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD4506W	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA453M	EUDAMEDFDA UDI	Class IIb	Active
Multi Joint Handle	MJH	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS09	EUDAMEDFDA UDI	Class I	Active
Denture 4U Guide	D4UG	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD3515	EUDAMEDFDA UDI	Class IIa	Active
Screw Holder	OSHR	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS05	EUDAMEDFDA UDI	Class I	Active
Ms Kit	HMISLK	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C4007	EUDAMEDFDA UDI	Class IIa	Active
CAS Drill	SNDR4113TS	EUDAMEDFDA UDI	Class IIa	Active
Machine Screw Driver	AMSD12E	EUDAMEDFDA UDI	Class IIa	Active
Twist Drill	2D2208LC01	EUDAMEDFDA UDI	Class IIa	Active
TS Fixture Transfer Impression Coping	GSTIM4514N	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA406M	EUDAMED	Class IIb	Active
Bone Screw	BSCH1408	EUDAMED	Class IIb	Active
Mount Driver	ASMDL	EUDAMEDFDA UDI	Class IIa	Active
NoMount Driver	SSNMDL	EUDAMEDFDA UDI	Class IIa	Active
TS Rigid Impression Coping	GSRIC470S	EUDAMED	Class I	Active
Cortical Drill 3	CD4C45	EUDAMEDFDA UDI	Class IIa	Active
US Pick-up Guide Pin	GPW100	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS05W	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