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, Belt And/Or Gear Driven, Dental (EFA) (7) Handpiece, Direct Drive, Ac-Powered (EKX) (2) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (1)

Premarket Exempt

No Yes

Clear

X-CUBE - 08809260470392 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470408 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470415 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470422 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470439 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470446 Catalog Number :

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470453 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EFA

Prescription Use : No

Device Count : 1

X-CUBE - 08809260470460 Catalog Number :

Device Description : Angle Handpiece

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EGS

Prescription Use : No

Device Count : 1

E-CUBE - 08809260470477 Catalog Number :

Device Description : Control Box

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

E-CUBE - 08809260470484 Catalog Number :

Device Description : Implant Motor

Device Class : 1

Duns Number: 688019566

Premarket Exempt : No

Product Code : EKX

Prescription Use : No

Device Count : 1

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