| Primary Device ID | 00816063022213 |
| NIH Device Record Key | 7f04b4a3-de38-44db-af07-71d84420591b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTero Lumina Pro |
| Version Model Number | 221951 |
| Company DUNS | 013831768 |
| Company Name | Align Technology, Inc. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |