Saeshin Precision Co., Ltd.

Address:52, Secheon-ro 1-gil, Dasa-eup, Dalseong-gun,Daegu,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) (4) Handpiece, Direct Drive, Ac-Powered (EKX) (4) Drill, Bone, Powered (DZI) (3) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (3) Handpiece, Water-Powered (EKY) (2)

Premarket Exempt

No Yes

Clear

TRAUS SUS10 - 08809260470101 Catalog Number :

Device Description : 20.:1 , optic

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EGS, EBW, DZI

Prescription Use : No

Device Count : 1

TRAUS SUS10 - 08809260470118 Catalog Number :

Device Description : 20:1, Non-optic

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EGS, EBW, DZI

Prescription Use : No

Device Count : 1

TRAUS SUS10 - 08809260470125 Catalog Number :

Device Description : 145.3(L) x 23.8(D)

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EGS, EBW, DZI

Prescription Use : No

Device Count : 1

TRAUS SIP10 - 08809260470163 Catalog Number :

Device Description : Control Box272.0(W) x 203.0(D) x 67.4(H)

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470200 Catalog Number :

Device Description : Angle Handpiece92.7(L) x 20.0(D)

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470231 Catalog Number :

Device Description : Control Box

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470248 Catalog Number :

Device Description : Charger

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470255 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470262 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470286 Catalog Number :

Device Description : Control Box

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EBW

Prescription Use : No

Device Count : 1

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