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

Brevis - 00813110020611 Catalog Number : 260-100-408

Device Description : 6.0mm 0° Brevis™ Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Brevis - 00813110020628 Catalog Number : 260-100-409

Device Description : 6.0mm 15° Brevis™ Abutment - 2.0mm Post

Device Class : 2

Duns Number: 945015758

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

Integra-Ti - 00813110020635 Catalog Number : 260-130-208

Device Description : 3.0 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

Non-Shouldered Abutment - 00813110020642 Catalog Number : 260-135-001

Device Description : 3.5 x 6.5mm 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

Integra-Ti - 00813110020659 Catalog Number : 260-135-008

Device Description : 3.5 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 - 00813110020666 Catalog Number : 260-135-011

Device Description : 3.5 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 - 00813110020673 Catalog Number : 260-135-015

Device Description : 3.5 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

Temporary Abutment - 00813110020680 Catalog Number : 260-135-245

Device Description : 3.5 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

Temporary Abutment - 00813110020697 Catalog Number : 260-135-265

Device Description : 3.5 x 6.5mm Temporary 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 - 00813110020703 Catalog Number : 260-140-002

Device Description : 4.0 x 6.5mm 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

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