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

Handpiece, Water-Powered (EKY) (4) Handpiece, Direct Drive, Ac-Powered (EKX) (3) Controller, Foot, Handpiece And Cord (EBW) (2) Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment (HWE) (1)

Premarket Exempt

Yes No

Clear

TRAUS SSG10 - 08809260470590 Catalog Number :

Device Class : 1

Duns Number: 688019566

Premarket Exempt : Yes

Product Code : HWE

Prescription Use : No

Device Count : 1

TRAUS SIP10 - 08809260470705 Catalog Number :

Device Description : XIP10+FUS10+CRB27LX+MBP10SL32:1 , optic

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

TRAUS SIP10 - 08809260470712 Catalog Number :

Device Description : 32:1 , non-opticXIP10+FUS10+CRB27XX+MBP10SX

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

TRAUS SIP10 - 08809260470729 Catalog Number :

Device Description : 20:1 , opticXIP10+FUS10+CRB26LX+MBP10SL

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

TRAUS SIP10 - 08809260470736 Catalog Number :

Device Description : 20:1 , non-opticXIP10+FUS10+CRB26XX+MBP10SX

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKY

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470743 Catalog Number :

Device Description : 20:1TRAUS MCE10XX+TRAUS XEW10+ACL(B)-41EP

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470767 Catalog Number :

Device Description : '16:1TRAUS MCE10XX+TRAUS XEW10+ACL(B)-42EP

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

TRAUS ENDO - 08809260470774 Catalog Number :

Device Description : '10:1TRAUS MCE10XX+TRAUS XEW10+ACL(B)-46EP

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470781 Catalog Number :

Device Description : 1:1, Straight AngleX-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ATII

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EBW

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470798 Catalog Number :

Device Description : '1:1, Contra Angle(Lever Type #1)X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EBW

Prescription Use : No

Device Count : 1

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