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

Instruments, Dental Hand (DZN) (7) Drill, Dental, Intraoral (DZA) (3)

Premarket Exempt

No Yes

Clear

C&B Driver - D7850083N0 Catalog Number : 0083N

Device Description : 2.9/3.0/3.25mm C&B Driver (Long)Places 2.9/3.0 ISI C&B Implants and 3.25mm Solid 2.9/3.0/3.25mm C&B Driver (Long)Places 2.9/3.0 ISI C&B Implants and 3.25mm Solid Abutments for TSI/ERI

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

C&B Driver - D7850083NS0 Catalog Number : 0083NS

Device Description : 2.9/3.0/3.25mm C&B Driver (Short)Places 2.9/3.0mm ISI C&B Implants and 3.25mm So 2.9/3.0/3.25mm C&B Driver (Short)Places 2.9/3.0mm ISI C&B Implants and 3.25mm Solid Abutments for TSI/ERI

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

ISI O-Ball Driver/Extension - D7850091DRIVEREXT0 Catalog Number : 0091

Device Description : 4/5/6mm ISI O-Ball Driver/Extension

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Handpiece Driver Adapter - D7850097ADAPTER0 Catalog Number : 0097

Device Description : Handpiece Driver AdapterFor placement of the 5mm ISI/TSI/ERI Maxillary Final Drill

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Profiling Bur for ISI/TSI/ERI - D7850098PB0 Catalog Number : 0098

Device Description : 3/3.25mm Profiling Bur3/3.25mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Profiling Bur for ISI/TSI/ERI - D7850099PB0 Catalog Number : 0099

Device Description : 4mm Profiling Bur

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Profiling Bur for ISI/TSI/ERI - D7850100PB0 Catalog Number : 0100

Device Description : 5mm Profiling Bur5mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Pilot Drill - D7850150PD0 Catalog Number : 0150 (1.5mm)

Device Description : 1.5mm Pilot Drill1.5mm DiameterUse the 1.5mm drill for the 2.2mm SDI

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Pilot Drill - D7850180PD0 Catalog Number : 0180 (1.8mm)

Device Description : 1.8mm Pilot Drill1.8mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850240T0 Catalog Number : 0240T

Device Description : 2.4mm Osteotomy Former2.4mm DiameterFor placement of the 3mm Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

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