| Primary Device ID | 00816063022091 |
| NIH Device Record Key | 004055c7-b019-4331-b5b3-c0e542d988a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) |
| Version Model Number | 221572 |
| 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 | true |
| Serial Number | false |
| 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 | 00816063022091 [Primary] |
| NXC | Aligner, Sequential |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-24 |
| Device Publish Date | 2024-05-16 |
| 00816063022091 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) | 2024-05-24Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes in the treatment of Class I and Class II malocclusion, severe open bite, severe overjet, deep bite, skeletally narrow jaw, and those who require surgical correction. |
| 00816063022091 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) | 2024-05-24 Invisalign System with Mandibular Advancement Featuring Occlusal Blocks (MAOB) is used to introduce mandibular skeletal changes |
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| 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) |