| Primary Device ID | 00855022009292 |
| NIH Device Record Key | 26cae0c9-17dd-4a7f-85a7-9e7c28d0c3c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SD NATURALS |
| Version Model Number | U128055-R-1 |
| Company DUNS | 203478896 |
| Company Name | Spa-Dent Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | true |