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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 2 of 10

Device	Model / Reference	Registries	Class	Status
TS Bite Index	GSBIM4506S	EUDAMEDFDA UDI	Class I	Active
Rigid Outer Driver	ORDMS	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS06W	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD4008	EUDAMEDFDA UDI	Class IIa	Active
Taper Fixture Surgical Tap	OFTS40	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD4507W	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C5506	EUDAMEDFDA UDI	Class IIa	Active
123 Twist Drill	2D2230S	EUDAMEDFDA UDI	Class IIa	Active
TS Fixture Transfer Impression Coping	GSTIS7011N	EUDAMEDFDA UDI	Class I	Active
Stopper	OCDS04	EUDAMEDFDA UDI	Class I	Active
Twist Drill	3D4318FNLC	EUDAMEDFDA UDI	Class IIa	Active
Bone Condenser	SNBC2333	EUDAMEDFDA UDI	Class I	Active
Bone Screw Driver Tip	BSCHDT	EUDAMEDFDA UDI	Class I	Active
123 Twist Drill	2D2230L	EUDAMEDFDA UDI	Class IIa	Active
Trephine Drill	TD42	EUDAMEDFDA UDI	Class IIa	Active
Stopper	LSNST1.0	EUDAMEDFDA UDI	Class I	Active
Ti Abutment Screw	ASR200	EUDAMEDFDA UDI	Class IIb	Active
Autobone Collector	ABC404S	EUDAMEDFDA UDI	Class IIa	Active
Hydraulic Membrane Lifter	OCHML	EUDAMEDFDA UDI	Class I	Active
OneGuide Taper Drill	OGTPD3510	EUDAMEDFDA UDI	Class IIa	Active
Machine Screw Driver	AMSD05L	EUDAMEDFDA UDI	Class IIa	Active
Taper Kit	HTAPEK	EUDAMEDFDA UDI	Class IIa	Active
OneCAS Drill	OCD3807W	EUDAMEDFDA UDI	Class IIa	Active
Torque Driver For Torque Wrench	TRSD05L	EUDAMEDFDA UDI	Class I	Active
Ks Fixture Driver	KSFDS	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA407M	EUDAMEDFDA UDI	Class IIb	Active
Taper Drill	TPD3C3515	EUDAMEDFDA UDI	Class IIa	Active
Hiossen Prosthetic System	K140507	FDA 510(k)FDA UDI	Class II	Active
Transfer & Angled Abutment	K153015	FDA 510(k)	Class II	Active
Et Prosthetic System	K130662	FDA 510(k)	Class II	Active
Smartbuilder System (sb1)	K130840	FDA 510(k)	Class II	Active
Ts Fixture System	K121995	FDA 510(k)	Class II	Active
Hu Ii / Hs Ii Fixture System	K080387	FDA 510(k)	Class II	Active
Nt/It System	K081078	FDA 510(k)	Class II	Active
Ms Sa Implant System	K122171	FDA 510(k)	Class II	Active
ET US SS Prosthetic system	K160670	FDA 510(k)	Class II	Active
Prosthetic System	K110308	FDA 510(k)	Class II	Active
Us/Ss/Gs System	K073247	FDA 510(k)	Class II	Active
Ms System	K083067	FDA 510(k)	Class II	Active
Hs/Hg Prosthetic System	K100245	FDA 510(k)	Class II	Active
Et/Ss Implant System	K120847	FDA 510(k)	Class II	Active
HySil Impression Materials	K170736	FDA 510(k)FDA UDI	Class II	Active
Np-Cast Abutment System	K121843	FDA 510(k)	Class II	Active
TS Abutment System	K233194	FDA 510(k)	Class II	Active
Ms System (provisional)	K072871	FDA 510(k)	Class II	Active
Gs System	K063861	FDA 510(k)	Class II	Active
T1-Cs, T1-C	K183475	FDA 510(k)	Class II	Active
Portable X-Ray System (model:exaro, Xray2go)	K141497	FDA 510(k)	Class II	Active
Healing Abutment System	K251434	EUDAMEDFDA 510(k)	Class II	Active
T2 Plus	K233806	FDA 510(k)	Class II	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