| Primary Device ID | 00883205015549 |
| NIH Device Record Key | 6c83768a-6e35-4dab-a5d9-fb13b6c5b28f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Opal Bond Flow |
| Version Model Number | 500079 |
| Catalog Number | 500079 |
| Company DUNS | 013369913 |
| Company Name | ULTRADENT PRODUCTS, 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 | false |
| Manufacturing Date | false |
| 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 |