| Primary Device ID | D80723400031 |
| NIH Device Record Key | 91e02e2b-b60e-44b7-9413-ea1863928884 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEWGEAR |
| Version Model Number | 23-400-03 |
| Catalog Number | 23-400-03 |
| Company DUNS | 116903307 |
| Company Name | DENTSPLY SIRONA ORTHODONTICS INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |