| Primary Device ID | D8323000T0 |
| NIH Device Record Key | a5810e84-9df8-4d6b-b25f-f11fb7429676 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXPANDII FLOSSII |
| Version Model Number | 3000T |
| Catalog Number | 3000T |
| Company DUNS | 190377184 |
| Company Name | PLASDENT CORPORATION |
| Device Count | 72 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |