| Primary Device ID | 03760260222051 |
| NIH Device Record Key | de9b3e62-c63d-4a23-9e82-cd1c4d73eebd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DENTOCROWN |
| Version Model Number | A1B1 |
| Catalog Number | DWN-A1B1 |
| Company DUNS | 262150858 |
| Company Name | ITENA CLINICAL |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |