| Primary Device ID | 00852550007295 |
| NIH Device Record Key | 14805661-c6d9-4d8a-9c55-5de898355795 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 8 MM IC SMALL DIAMETER NON-EXPANDABLE IMPLANT |
| Version Model Number | 3808ISD |
| Company DUNS | 017725036 |
| Company Name | Bio-Dent, Inc. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |