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) (7) Instruments, Dental Hand (DZN) (2) Gauge, Depth, Instrument, Dental (EIL) (1)

Premarket Exempt

No Yes

Clear

Restorative System - D785RESTORATIVEKIT0 Catalog Number : Restorative Kit

Device Description : Restorative Instrumentation SystemEverything you need to restore our entire line Restorative Instrumentation SystemEverything you need to restore our entire line of two-stage implantsA system that contains all instrumentation needed to restore our entire line of two stagedental implants; including the TSI, ERI, Engage™ and Macro™. All components are labeledfor easy removal and return to the tray after autoclaving for sterilization.

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : EIL

Prescription Use : No

Device Count : 1

Ridge Mapping Caliper - D785RIDGEMC0 Catalog Number : RMC

Device Description : Ridge Mapping Caliper

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Locator Square Drive Tool - D785S89270 Catalog Number : 8927

Device Description : Locator Square Drive Tool (Short)Driver for Locator Abutments

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Small Diameter Dental Implant - D785SDI2210CB0 Catalog Number : SDI 2210 CB

Device Description : Small Diameter Implant:2.2mm 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 - D785SDI2210OB0 Catalog Number : SDI 2210 OB

Device Description : Small Diameter Dental Implant:2.2mm 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 - D785SDI2212CB0 Catalog Number : SDI 2212 CB

Device Description : Small Diameter Dental Implant:2.2mm 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 - D785SDI2212OB0 Catalog Number : SDI 2212 OB

Device Description : Small Diameter Dental Implant:2.2mm 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 - D785SDI2214CB0 Catalog Number : SDI 2214 CB

Device Description : Small Diameter Dental Implant:2.2mm 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 - D785SDI2214OB0 Catalog Number : SDI 2214 OB

Device Description : Small Diameter Dental Implant:2.2mm 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 - D785SDI2216CB0 Catalog Number : SDI 2216 CB

Device Description : Small Diameter Dental Implant:2.2mm Diameter X 16mm Length

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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