OCO BIOMEDICAL INC

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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

Implant, Endosseous, Root-Form (DZE) (9) Instruments, Dental Hand (DZN) (1)

Premarket Exempt

No Yes

Clear

Small Diameter Dental Implant - D785SDI2908OB0 Catalog Number : SDI 2908 OB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 8mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2910CB0 Catalog Number : SDI 2910 CB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 10mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2910OB0 Catalog Number : SDI 2910 OB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 10mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2912CB0 Catalog Number : SDI 2912 CB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 12mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2912OB0 Catalog Number : SDI 2912 OB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 12mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2914CB0 Catalog Number : SDI 2914 CB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 14mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2914OB0 Catalog Number : SDI 2914 OB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 14mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2916CB0 Catalog Number : SDI 2916 CB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 16mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Small Diameter Dental Implant - D785SDI2916OB0 Catalog Number : SDI 2916 OB

Device Description : Small Diameter Dental Implant:2.9mm Diameter X 16mm length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

SDI Driver - D785SDIMDL0 Catalog Number : MD-L

Device Description : 2.2/2.5mm SDI Driver (Long)Places both C&B and O-Ball 3.0 Implants

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

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