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) (8) Gauge, Depth, Instrument, Dental (EIL) (2)

Premarket Exempt

No Yes

Clear

Paralleling Pin - D785ISIP40 Catalog Number : ISI-P 4.0

Device Description : 4mm Paralleling Pin4mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Paralleling Pin - D785ISIP50 Catalog Number : ISI-P 5.0

Device Description : 5mm Paralleling Pin5mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Locaator Square Drive Tool - D785L89260 Catalog Number : 8926

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

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : EIL

Prescription Use : No

Device Count : 1

Locator Core Tool - D785LCT83930 Catalog Number : 8393

Device Description : Locator Core ToolPlaces the Locator Abutments and Replacement Males

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Locator - D785LPP85170 Catalog Number : 8517

Device Description : Locator Parallel Post

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : EIL

Prescription Use : No

Device Count : 1

Straight Osteotome - D785OST180 Catalog Number : OST 1.8

Device Description : 1.8mm Straight Osteotome1.8mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Straight Osteotome - D785OST2650 Catalog Number : OST 2.65

Device Description : 2.65mm Straight Osteotome 2.65mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Straight Osteotome - D785OST340 Catalog Number : OST 3.4

Device Description : 3.4mm Straight Osteotome 3.4mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Straight Osteotome - D785OST440 Catalog Number : OST 4.4

Device Description : 4.4mm Straight Osteotome 4.4mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

Straight Osteotome Kit - D785OSTKIT0 Catalog Number : OST Kit

Device Description : Straight Osteotome Kit (4)All 4 with case1.8mm Straight Osteotome2.65mm Straight Straight Osteotome Kit (4)All 4 with case1.8mm Straight Osteotome2.65mm Straight Osteotome3.4mm Straight Osteotome4.4mm Straight Osteotome

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : No

Device Count : 1

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