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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 1 of 10

Device	Model / Reference	Registries	Class	Status
Multi Angled Abutment	K123755	FDA 510(k)	Class II	Active
SS Octa Plastic Cylinder	SSPSN480TH	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA453M	EUDAMEDFDA UDI	Class IIb	Active
122 Taper Drill	122TPD5511	EUDAMEDFDA UDI	Class IIa	Active
Taper Drill	TPD3C7008	EUDAMEDFDA UDI	Class IIa	Active
OneCAS Drill	OCD3110W	EUDAMEDFDA UDI	Class IIa	Active
TS Fixture Transfer Impression Coping	GSTIS4511N	EUDAMEDFDA UDI	Class I	Active
SS Excellent Solid Impression Coping	SSEIC485	EUDAMEDFDA UDI	Class I	Active
NoMount Driver	TSNMDML	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D5004	EUDAMEDFDA UDI	Class IIa	Active
SS Octa Transfer Impression Coping	SSOTI600	EUDAMEDFDA UDI	Class I	Active
OneCAS Drill	OCD3610	EUDAMEDFDA UDI	Class IIa	Active
TS Rigid Outer Driver	ORD45L	EUDAMEDFDA UDI	Class I	Active
Anterior Hand Driver For Implant	AHDI	EUDAMEDFDA UDI	Class I	Active
Bone Condenser	SNBC1114	EUDAMEDFDA UDI	Class I	Active
Twist Drill	3D3318FNLC	EUDAMEDFDA UDI	Class IIa	Active
Drill Extension	ODE	EUDAMEDFDA UDI	Class IIa	Active
TS Healing Abutment	TSHA454M	EUDAMEDFDA UDI	Class IIb	Active
Saw	HSAW100	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D4506	EUDAMEDFDA UDI	Class IIa	Active
Tissue Punch	OGTP50	EUDAMEDFDA UDI	Class IIa	Active
485 Drill	O485D4507	EUDAMEDFDA UDI	Class IIa	Active
OneGuide SS NoMount Driver	OGNMDR50S	EUDAMEDFDA UDI	Class IIa	Active
TS Convertible Polishing Protector	GSCPC400	EUDAMED	Class I	Active
122 Taper Drill	122TPD5505	EUDAMEDFDA UDI	Class IIa	Active
Fixture Driver	OGFDR50	EUDAMED	Class I	Active
Crest Remover	CERM70A	EUDAMEDFDA UDI	Class IIa	Active
Stopper	SNST12	EUDAMEDFDA UDI	Class I	Active
TS Healing Abutment	TSHA453R	EUDAMEDFDA UDI	Class IIb	Active
122 Taper Drill	122TPD4004	EUDAMEDFDA UDI	Class IIa	Active
OneGuide Taper Drill	OGTPD3513	EUDAMEDFDA UDI	Class IIa	Active
122 Taper Drill	122TPD3510	EUDAMEDFDA UDI	Class IIa	Active
Stopper	OCDS03W	EUDAMEDFDA UDI	Class I	Active
122 Taper Drill	122TPD6013	EUDAMEDFDA UDI	Class IIa	Active
TS Bite Index	GSBIM4512S	EUDAMEDFDA UDI	Class I	Active
Path Probe	GIPAP-3516A	EUDAMEDFDA UDI	Class I	Active
Depth Gauge	ODG	EUDAMEDFDA UDI	Class I	Active
Fixture Driver	GSMFDL	EUDAMEDFDA UDI	Class I	Active
485 Drill	O485D4504	EUDAMEDFDA UDI	Class IIa	Active
Expansion Drill	EXP324711	EUDAMEDFDA UDI	Class IIa	Active
SS Octa Plastic Cylinder	SSPSO480TH	EUDAMEDFDA UDI	Class I	Active
SS Solid Impression Coping	SSIC484	EUDAMEDFDA UDI	Class I	Active
OneCAS Drill	OCD4107W	EUDAMEDFDA UDI	Class IIa	Active
Twist Drill	2D2018FNLC	EUDAMEDFDA UDI	Class IIa	Active
Depth Gauge	OCDGW	EUDAMEDFDA UDI	Class I	Active
Stopper	SNST1	EUDAMEDFDA UDI	Class I	Active
OneCAS Twist Drill	OCD2207	EUDAMEDFDA UDI	Class IIa	Active
TS NoMount Driver	TSNMDRL	EUDAMEDFDA UDI	Class IIa	Active
AutoBone Collector	ABC604S	EUDAMEDFDA UDI	Class IIa	Active
Crest Remover	CERM50A	EUDAMEDFDA UDI	Class IIa	Active

Related Companies

Authorised Representatives

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Authorities

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FDA Establishments (1)

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

OSSTEM IMPLANT Co., Ltd. US