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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 5 of 10

Device	Model / Reference	Registries	Class	Status
Re-tap	ORTR	EUDAMEDFDA UDI	Class I	Active
Angled Torque Driver	ATD12L	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD5006W	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C4006	EUDAMEDFDA UDI	Class IIa	Active
Stopper	OCDS09W	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD3508	EUDAMEDFDA UDI	Class IIa	Active
Stopper	ABC2ST404L	EUDAMEDFDA UDI	Class I	Active
Angled Torque Driver SET	ATD12S3S	EUDAMEDFDA UDI	Class I	Active
Abutment Positioning Driver	OAPDL	EUDAMEDFDA UDI	Class I	Active
Ti Abutment Screw	ASW200	EUDAMEDFDA UDI	Class IIb	Active
Ms Parallel Pin	MSPPN	EUDAMEDFDA UDI	Class I	Active
Remover Screw	FRSR40US	EUDAMEDFDA UDI	Class I	Active
TS Scan body	TSSBOMTH	EUDAMEDFDA UDI	Class I	Active
485 Drill	O485D4004	EUDAMEDFDA UDI	Class IIa	Active
TS Scan Healing Abutment Carrier	TSSHAC400L	EUDAMEDFDA UDI	Class I	Active
SmartGuide	SGTSS	EUDAMEDFDA UDI	Class I	Active
SS Octa Pick-up Impression Coping	SSICN480	EUDAMEDFDA UDI	Class I	Active
Driver Handle	TIDHC	EUDAMEDFDA UDI	Class I	Active
Twist Drill	OSMSD18S	EUDAMEDFDA UDI	Class IIa	Active
Trephine Drill	TD62	EUDAMEDFDA UDI	Class IIa	Active
Depth Gauge	OSDG	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA503R	EUDAMEDFDA UDI	Class IIb	Active
Hand Driver	AHD12MH	EUDAMEDFDA UDI	Class I	Active
Remover Screw	FRSMNR35	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA403R	EUDAMEDFDA UDI	Class IIb	Active
Twist Drill	TD1513TL	EUDAMEDFDA UDI	Class IIa	Active
Scan body Holding Driver	TSNSBHDM	EUDAMEDFDA UDI	Class I	Active
Reverse Driver	ORVDML	EUDAMEDFDA UDI	Class I	Active
OneMS Drill	OMD1508	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5005	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD5513	EUDAMEDFDA UDI	Class IIa	Active
SS Solid Impression Coping	SSIC607	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD3513	EUDAMEDFDA UDI	Class IIa	Active
Single Guide	SGB070	EUDAMEDFDA UDI	Class I	Active
CAS Drill	SNDR3613TS	EUDAMEDFDA UDI	Class IIa	Active
Remover Screw	FRSR40F	EUDAMEDFDA UDI	Class I	Active
123 Straight KIT	O123FK	EUDAMED	Class IIa	Active
TS Scan Healing Abutment Carrier	TSSHAC500	EUDAMEDFDA UDI	Class I	Active
SmartGuide	SGTB63SS	EUDAMEDFDA UDI	Class I	Active
122 Taper KIT	O122TPK	EUDAMED	Class IIa	Active
Screw Removal Tip	ORT18L	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS08W	EUDAMEDFDA UDI	Class I	Active
TS Fixture Transfer Impression Coping	GSTIS4514	EUDAMEDFDA UDI	Class I	Active
Orthodontic Screw Driver Tip	OSDTS	EUDAMEDFDA UDI	Class I	Active
Scan body Holding Driver	TSNSBHDR	EUDAMEDFDA UDI	Class I	Active
TS Scan Healing Abutment Carrier	TSSHAC450L	EUDAMEDFDA UDI	Class I	Active
123 Twist Drill	2D3036FNS	EUDAMEDFDA UDI	Class IIa	Active
TS Pick-up Guide Pin	GSPGPM100	EUDAMEDFDA UDI	Class I	Active
OneMS Drill	OMD2710	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C5508	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

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FDA Establishments (1)

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

OSSTEM IMPLANT Co., Ltd. US