| Primary Device ID | 00816063020288 |
| NIH Device Record Key | e1e9943e-8484-40e3-89f4-ce8b8eddea06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTero Element 2 |
| Version Model Number | 202965 |
| Company DUNS | 013831768 |
| Company Name | ALIGN TECHNOLOGY, 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816063020288 [Primary] |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-01 |
| Device Publish Date | 2018-05-01 |
| 00816063022138 - iTero Lumina Scanning Unit | 2024-02-23 Scanning unit (wand) |
| 00816063021421 - iTero Lumina Cart upgrade from Element Plus | 2024-02-09 Upgrade kit for existing iTero users who upgrade their Plus scanner to Lumina scanner |
| 00816063021438 - iTero Lumina Mobile Configuration | 2024-02-09 iTero Lumina Intraoral scanner Mobile Configuration |
| 00816063021452 - iTero Lumina DOA Cart | 2024-02-09 Replacement package of iTero Lumina scanner in case of DOA |
| 00816063021469 - iTero Lumina RMA Scanning Unit | 2024-02-09 Scanning unit (wand) replacement package |
| 00816063021483 - iTero Lumina 25 Disposable Sleeves Box | 2024-02-09 Disposable single use sleeves box |
| 00816063021599 - iTero Lumina scanning unit | 2024-02-09 Scanning unit (wand) |
| 00816063021841 - iTero Lumina RMA, PPC Unit | 2024-02-09 Replacement package of cart computing unit - iTero Lumina |