COHO BIOMEDICAL TECHNOLOGY CO., LTD.

Address:21 Dafeng Street,Luzhu District Taoyuan,TW

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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

Abutment, Implant, Dental, Endosseous (NHA) (7) Implant, Endosseous, Root-Form (DZE) (7) Blade, Scalpel (GES) (3)

Premarket Exempt

No Yes

Clear

Zibone - 04710986431274 Catalog Number :

Device Description : #63 BLADE

Device Class : 1

Duns Number: 658658526

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 1

Zibone - 04710986431281 Catalog Number :

Device Description : #65 BLADE

Device Class : 1

Duns Number: 658658526

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 1

Zibone - 04710986431298 Catalog Number :

Device Description : #11 BLADE(Used with the handle CST-H04)

Device Class : 1

Duns Number: 658658526

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 1

Zircasso - 04710986431304 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 4.1 mm,Length : 8 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : DZE, NHA

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431311 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 4.1 mm,Length : 10 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : NHA, DZE

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431328 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 4.1 mm,Length : 12 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : NHA, DZE

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431335 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 4.1 mm,Length : 14 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : DZE, NHA

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431342 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 5.1 mm,Length : 8 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : NHA, DZE

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431359 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 5.1 mm,Length : 10 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : DZE, NHA

Prescription Use : Yes

Device Count : 1

Zircasso - 04710986431366 Catalog Number :

Device Description : One piece zirconia dental implant.Diameter : 5.1 mm,Length : 12 mm

Device Class : 2

Duns Number: 658658526

Premarket Exempt : No

Product Code : NHA, DZE

Prescription Use : Yes

Device Count : 1

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