Total clearances
11
2020-03-20 → 2026-07-02
Name variants in FDA filings: Align Technology, Inc. / Align Technology , Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| NXC |
Aligner, Sequential |
Class II |
Dental |
8 |
2025-10-23 |
| NTK |
Light Transmission Caries Detector |
Class II |
Dental |
3 |
2026-07-02 |
Safety
Recalls (1)
Class I (serious)
0
Risk of injury / death
| Date | Severity | Status | Recall # |
Product | Code | Reason |
| 2022-12-05 |
Class II
|
Completed |
Z-1017-2023 |
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001 |
— |
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor request… |
Filings
All 510(k) clearances (11)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-02 |
K261847 |
iTero Lumina Pro |
NTK |
Class II |
Dental |
| 2025-10-23 |
K252931 |
Invisalign® Palatal Expander System |
NXC |
Class II |
Dental |
| 2025-10-09 |
K252870 |
Invisalign Specifix Attachment System |
NXC |
Class II |
Dental |
| 2025-08-29 |
K252380 |
Invisalign System |
NXC |
Class II |
Dental |
| 2024-08-16 |
K240573 |
iTero Lumina Pro |
NTK |
Class II |
Dental |
| 2024-06-18 |
K241412 |
Invisalign System |
NXC |
Class II |
Dental |
| 2023-12-15 |
K232887 |
Invisalign Palatal Expander System |
NXC |
Class II |
Dental |
| 2023-09-26 |
K232233 |
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks |
NXC |
Class II |
Dental |
| 2022-12-22 |
K222894 |
Invisalign System, Pre-Formed Attachment System |
NXC |
Class II |
Dental |
| 2022-04-07 |
K220287 |
Invisalign System |
NXC |
Class II |
Dental |
| 2020-03-20 |
K193659 |
iTero Element 5D |
NTK |
Class II |
Dental |