| Primary Device ID | 00852550007332 |
| NIH Device Record Key | dc45388e-4d8a-4a22-a20e-72d82a1b900a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 8 MM IC WIDE DIAMETER NON-EXPANDABLE IMPLANT |
| Version Model Number | 3808IWD |
| 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 |