| Primary Device ID | 00813110023568 |
| NIH Device Record Key | aaeacf3b-3aa6-4fb1-83b2-ff2c62c08c9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fixed-Detachable Component |
| Version Model Number | 260-100-021 |
| Catalog Number | 260-100-021 |
| Company DUNS | 945015758 |
| Company Name | BICON, LLC |
| Device Count | 4 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813110023568 [Primary] |
| GS1 | 00813110027627 [Unit of Use] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00813110023568]
Moist Heat or Steam Sterilization
[00813110023568]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-03-25 |
| Device Publish Date | 2016-09-19 |
| 00813110023568 | 3.0mm Hex Cover Screw |
| 00813110023551 | Hex Retention Screw |
| 00813110023544 | Metal Transfer Coping |
| 00813110023537 | 10mm Hex Coping Screw |
| 00813110023520 | 5.0mm Hex Coping Screw |
| 00813110023490 | Fixed-Detachable Abutment Analog |
| 00813110023483 | Plastic Transfer Coping |
| 00813110027610 | Titanium Coping (2) |