COMPANY
Align Technology
Align Technology is a global medical device company that is changing lives through better smiles. From company website Source · Oct 12, 2026
Timeline
- FDA FDA 510(k) clearance: Invisalign System — K262196, Sep 25, 2026. Applicant at approval: Align Technology, Inc. source ↗
- FDA FDA 510(k) clearance: Invisalign® Palatal Expander System — K252931, Oct 23, 2025. Applicant at approval: Align Technology, Inc. source ↗
- FDA FDA 510(k) clearance: Invisalign Specifix Attachment System — K252870, Oct 9, 2025. Applicant at approval: Align Technology, Inc. source ↗
- FDA FDA 510(k) clearance: Invisalign System — K252380, Aug 29, 2025. Applicant at approval: Align Technology, Inc. source ↗
- Trial start Not phased (device or behavioral study): Hyrax Vs. Invisalign Palatal Expander Clinical Study source ↗
- Trial start Not phased (device or behavioral study): Invisalign® System with Mandibular Advancement source ↗
- Trial start —: One Week Aligner Evaluation source ↗
- Trial start Not phased (device or behavioral study): Primer Aligner Study source ↗
- Trial start Not phased (device or behavioral study): Class II Correction Study Using the Invisalign System source ↗
- Trial start Not phased (device or behavioral study): The Use of Clear Aligners With Movement Enhancement Techniques source ↗
Upcoming milestones
- Dec 31, 2026 (ESTIMATED) · Not phased · Invisalign® System with Mandibular Advancement · NCT06651944
Clinical trials (lead sponsor) 6
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06662279 | Hyrax Vs. Invisalign Palatal Expander Clinical Study | Not phased (device or behavioral study) | Recruiting | Oct 25, 2024 | 2025-11 (estimated) |
| NCT06651944 | Invisalign® System with Mandibular Advancement | Not phased (device or behavioral study) | Recruiting | Feb 14, 2024 | Dec 31, 2026 (estimated) |
| NCT02376829 | Class II Correction Study Using the Invisalign System | Not phased (device or behavioral study) | Completed | 2015-03 | Nov 23, 2021 (actual) |
| NCT02550938 | Primer Aligner Study | Not phased (device or behavioral study) | Completed | 2015-05 | 2020-09 (actual) |
| NCT02603289 | One Week Aligner Evaluation | Not listed | Completed | 2015-09 | 2018-11 (actual) |
| NCT02087163 | The Use of Clear Aligners With Movement Enhancement Techniques | Not phased (device or behavioral study) | Completed | 2014-02 | 2018-12 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: Invisalign System — K262196, Sep 25, 2026. Applicant at approval: Align Technology, Inc. source ↗
- FDA 510(k) clearance: Invisalign® Palatal Expander System — K252931, Oct 23, 2025. Applicant at approval: Align Technology, Inc. source ↗
- FDA 510(k) clearance: Invisalign Specifix Attachment System — K252870, Oct 9, 2025. Applicant at approval: Align Technology, Inc. source ↗
- FDA 510(k) clearance: Invisalign System — K252380, Aug 29, 2025. Applicant at approval: Align Technology, Inc. source ↗
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