| Primary Device ID | 00813110023414 |
| NIH Device Record Key | a9d27a2a-c62a-4af1-b711-eb227c7b16ed |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 260-028-150 |
| Catalog Number | 260-028-150 |
| Company DUNS | 945015758 |
| Company Name | BICON, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813110023414 [Primary] |
| EKX | Handpiece, Direct Drive, Ac-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-11-01 |
| 00813110029485 - Temporary Abutment | 2024-01-23 7.0mm Thin Crestal Temporary Abutment - 3.0mm Tall Post |
| 00813110029577 - Temporary Abutment | 2023-10-10 5.0 x 6.5mm Scannable Temporary Abutment - 3.0mm Tall Post |
| 00813110029553 - Pliers | 2023-07-13 Diamond Pliers |
| 00813110029560 - Tweezers | 2023-07-13 Titanium Tweezers |
| 00813110029539 - Instrument | 2023-07-11 Mesh Screwdriver |
| 00813110029546 - Screw | 2023-07-11 Mesh Retention Screw (2) |
| 00813110029508 - Temporary Abutment | 2023-06-15 4.0 x 4.5mm Scannable Temporary Abutment - 2.0mm Tall Post |
| 00813110029515 - Coping | 2023-05-09 UA5 LP Retentive Ring (2) |