| Primary Device ID | 00816063022329 |
| NIH Device Record Key | 632a4449-6a18-46c4-9e63-415f9bb5f273 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | iTero Lumina Pro DOA |
| Version Model Number | 221971 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816063022329 [Primary] |
| NTK | Caries Detector, Laser Light, Transmission |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-27 |
| Device Publish Date | 2024-11-19 |
| 00816063021377 - Invisalign Go Express | 2025-09-23 Aligner |
| 00816063022923 - Vivera™ 3D retainers | 2025-04-23 Vivera™ 3D retainers are 3D printed retainers indicated for maintaining and preventing movement of a patient's dentition. |
| 00816063023067 - iTero Lumina Pro | 2025-03-14 iTero Lumina Pro Software |
| 00816063022800 - Invisalign Pre-Formed Attachment System | 2025-03-10 The Invisalign Pre-Formed Attachment System is a doctor prescribed, patient specific system for the bonding of 3D-printed attach |
| 00816063022213 - iTero Lumina Pro | 2024-11-27 iTero Lumina Pro US Cart Configuration |
| 00816063022237 - iTero Lumina Pro Mobile | 2024-11-27 iTero Lumina Pro US Mobile Configuration |
| 00816063022268 - iTero Lumina Pro intraoral scanning unit | 2024-11-27 iTero Lumina Pro Scanning Unit, RMA Package US |
| 00816063022329 - iTero Lumina Pro DOA | 2024-11-27iTero Lumina Pro US DOA Kit cart |
| 00816063022329 - iTero Lumina Pro DOA | 2024-11-27 iTero Lumina Pro US DOA Kit cart |