| Primary Device ID | 00810126042804 |
| NIH Device Record Key | 04da4a07-e528-4e64-9827-fa70466c51e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ET Bite Impression Coping |
| Version Model Number | ETBICR4620HC |
| Company DUNS | 796083090 |
| Company Name | HIOSSEN, INC. |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |