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

Drill, Dental, Intraoral (DZA) (7) Abutment, Implant, Dental, Endosseous (NHA) (3)

Premarket Exempt

No Yes

Clear

Osteotomy Former - D7850280T0 Catalog Number : 0280T

Device Description : 2.8mm Osteotomy Former2.8mm DiameterFor placement of the 3.25mm ISI/TSI/ERI Maxi 2.8mm Osteotomy Former2.8mm DiameterFor placement of the 3.25mm ISI/TSI/ERI Maxillary Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850300T0 Catalog Number : 0300T

Device Description : 3mm Osteotomy Former3mm DiameterFor placement of the 3.25mm ISI/TSI/ERI Mandibul 3mm Osteotomy Former3mm DiameterFor placement of the 3.25mm ISI/TSI/ERI Mandibular Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850350T0 Catalog Number : 0350T

Device Description : 3.5mm Osteotomy Former3.5mm DiameterFor placement of the 4mm ISI/TSI/ERI Maxillary Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850370T0 Catalog Number : 0370T

Device Description : 3.7mm Osteotomy Former3.7mm DiameterFor placement of the 4mm ISI/TSI/ERI Mandibu 3.7mm Osteotomy Former3.7mm DiameterFor placement of the 4mm ISI/TSI/ERI Mandibular Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850450T0 Catalog Number : 0450T

Device Description : 4.5mm Osteotomy Former4.5mm DiameterFor placement of the 5mm ISI/TSI/ERI Maxillary Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850470T0 Catalog Number : 0470T

Device Description : 4.7mm Osteotomy Former4.7mm DiameterFor placement of the 5mm ISI/TSI/ERI Mandibu 4.7mm Osteotomy Former4.7mm DiameterFor placement of the 5mm ISI/TSI/ERI Mandibular Implant

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Osteotomy Former - D7850560T0 Catalog Number : 0560T

Device Description : 5.6mm Osteotomy Former5.6mm Diameter

Device Class : 1

Duns Number: 094146123

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

Bone level Locator Abutment - D7851471LA0 Catalog Number : 1471

Device Description : 6mm Locator Abutment6mm Diameter1mm Height

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Bone Level Locator Abutment - D7851472LA0 Catalog Number : 1472

Device Description : 6mm Locator Abutment6mm Diameter2.5mm Height

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Bone level Locator Abutment - D7851473LA0 Catalog Number : 1473

Device Description : 6mm Locator Abutment6mm Diameter3.5mm Height

Device Class : 2

Duns Number: 094146123

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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