| Primary Device ID | 00816063023760 |
| NIH Device Record Key | 0c3b4f87-fb54-4636-b06e-610c63cf2b4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gumlines |
| Version Model Number | 226797 |
| 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 | 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 | 00816063023760 [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 | 2026-01-09 |
| Device Publish Date | 2026-01-01 |
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| 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 |