BICON, LLC

Address:501 Arborway,Boston,MA,02130,US

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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) (10)

Premarket Exempt

No Yes

Clear

Integra-Ti - 00813110020710 Catalog Number : 260-140-008

Device Description : 4.0 x 8.0mm Integra-Ti Implant - 2.0mm Well

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Integra-Ti - 00813110020727 Catalog Number : 260-140-011

Device Description : 4.0 x 11mm Integra-Ti Implant - 2.0mm Well

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Non-Shouldered Abutment - 00813110020734 Catalog Number : 260-140-015

Device Description : 4.0 x 6.5mm 15° Non-Shouldered Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Non-Shouldered Abutment - 00813110020741 Catalog Number : 260-140-025

Device Description : 4.0 x 6.5mm 25° Non-Shouldered Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Non-Shouldered Abutment - 00813110020758 Catalog Number : 260-140-101

Device Description : 4.0 x 10mm 0° Non-Shouldered Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Non-Shouldered Abutment - 00813110020765 Catalog Number : 260-140-115

Device Description : 4.0 x 10mm 15° Non-Shouldered Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Temporary Abutment - 00813110020772 Catalog Number : 260-140-245

Device Description : 4.0 x 4.5mm Temporary Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Integra-Ti - 00813110020789 Catalog Number : 260-140-251

Device Description : 4.0 x 11mm Integra-Ti Implant - 2.5mm Well

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Integra-Ti - 00813110020796 Catalog Number : 260-140-255

Device Description : 4.0 x 5.0mm Integra-Ti Implant - 2.5mm Well

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Integra-Ti - 00813110020802 Catalog Number : 260-140-256

Device Description : 4.0 x 6.0mm Integra-Ti Implant - 2.5mm Well

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

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