Primary Device ID | 00813110029003 |
NIH Device Record Key | 93ff831b-ea72-4cec-a748-bb00653e0dea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Fixed-Detachable |
Version Model Number | 260-100-039 |
Catalog Number | 260-100-039 |
Company DUNS | 945015758 |
Company Name | BICON, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com | |
Phone | 617-524-4443 |
support@bicon.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00813110029003 [Primary] |
NDP | Accessories, Implant, Dental, Endosseous |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-09 |
Device Publish Date | 2021-09-01 |
00813110027276 - Universal Abutment | 2024-10-29 Universal Abutment UA6 SP 0° - 3.0mm Tall Post |
00813110027283 - Universal Abutment | 2024-10-29 Universal Abutment UA6 SP 15° - 3.0mm Tall Post |
00813110029744 - Scan Post | 2024-10-29 2.0mm Titanium Scan Post (2) |
00813110029751 - Scan Post | 2024-10-29 2.5mm Titanium Scan Post (2) |
00813110029768 - Scan Post | 2024-10-29 3.0mm Titanium Scan Post (2) |
00813110029775 - Temporary Abutment | 2024-10-29 6.5 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post |
00813110029669 - Temporary Abutment | 2024-08-13 4.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Post |
00813110029676 - Temporary Abutment | 2024-08-13 4.0 x 4.5mm Scannable Temporary Abutment - 3.0mm Tall Post |