Osstem Implant Co., Ltd.

Osstem Implant Co., Ltd._Gasan Branch

Address:2 Floor, B-dong, 51, Mayu-ro 238beon-gil,Siheung-si Gyeonggi,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Controller, Foot, Handpiece And Cord (EBW) (3) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (3) Handpiece, Rotary Bone Cutting (KMW) (3) Unit, X-Ray, Extraoral With Timer (EHD) (1)

Premarket Exempt

Clear

Osstem - 08800000995014 Catalog Number :

Device Description : The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trai The Portable X-ray System (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.

Device Class : 2

Duns Number: 689515024

Premarket Exempt : No

Product Code : EHD

Prescription Use : No

Device Count : 1

SM3 - 08800000995212 Catalog Number :

Device Description : SM3 complete set - The SM3 is intended for use in dental oral surgery and dental SM3 complete set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Device Class : 1

Duns Number: 689515024

Premarket Exempt : No

Product Code : KMW, EGS, EBW

Prescription Use : Yes

Device Count : 1

SM3 - 08800000995229 Catalog Number :

Device Description : S200EL Contra angle only - The SM3 is intended for use in dental oral surgery an S200EL Contra angle only - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Device Class : 1

Duns Number: 689515024

Premarket Exempt : No

Product Code : KMW, EGS, EBW

Prescription Use : No

Device Count : 1

SM3 - 08800000995236 Catalog Number :

Device Description : Motor and cord set - The SM3 is intended for use in dental oral surgery and dent Motor and cord set - The SM3 is intended for use in dental oral surgery and dental implant. The main unit is designed to be used with a specific dental micromotor that drives dental handpieces fitted with appropriate tools to cut hard tissues in the mouth.

Device Class : 1

Duns Number: 689515024

Premarket Exempt : No

Product Code : KMW, EGS, EBW

Prescription Use : No

Device Count : 1

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