Align Technology, Inc.: FDA clearances and approvals
Align Technology, Inc. has 15 FDA 510(k) clearances (first 1998, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time: 81 days. Since 2017 its median was 63 days, against 128 days for all cleared 510(k)s in the same product codes. openFDA lists 1 product recall by a recalling firm named Align Technology, Inc. It is the industry lead sponsor of 6 device clinical trials on ClinicalTrials.gov. It files with the SEC as ALIGN TECHNOLOGY INC (ALGN).
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 331 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 1 | 116 |
| 2019 | 0 | — |
| 2020 | 1 | 81 |
| 2021 | 0 | — |
| 2022 | 2 | 78 |
| 2023 | 2 | 74 |
| 2024 | 2 | 100 |
| 2025 | 3 | 30 |
| 2026 | 1 | 29 |
Review time against the same product codes
Since 2017, Align Technology, Inc.'s cleared 510(k)s took a median 63 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 128 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NXC | Aligner, Sequential | 12 | 12 |
| NTK | Light Transmission Caries Detector | 3 | 3 |
Review panels
- Dental (15)
Most recent Align Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261847 | iTero Lumina Pro | NTK | 2026-07-02 | 29 |
| K252931 | Invisalign® Palatal Expander System | NXC | 2025-10-23 | 38 |
| K252870 | Invisalign Specifix Attachment System | NXC | 2025-10-09 | 30 |
| K252380 | Invisalign System | NXC | 2025-08-29 | 30 |
| K240573 | iTero Lumina Pro | NTK | 2024-08-16 | 168 |
| K241412 | Invisalign System | NXC | 2024-06-18 | 32 |
| K232887 | Invisalign Palatal Expander System | NXC | 2023-12-15 | 88 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | NXC | 2023-09-26 | 61 |
| K222894 | Invisalign System, Pre-Formed Attachment System | NXC | 2022-12-22 | 90 |
| K220287 | Invisalign System | NXC | 2022-04-07 | 65 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-12-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Align Technology, Inc. is the industry lead sponsor of 6 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06662279: Hyrax Vs. Invisalign Palatal Expander Clinical Study (Recruiting, started 2024-10-25)
- NCT06651944: Invisalign® System with Mandibular Advancement (Recruiting, started 2024-02-14)
- NCT02603289: One Week Aligner Evaluation (Completed, started 2015-09)
- NCT02550938: Primer Aligner Study (Completed, started 2015-05)
- NCT02376829: Class II Correction Study Using the Invisalign System (Completed, started 2015-03)
SEC filings
ALIGN TECHNOLOGY INC (ALGN): EDGAR filings, CIK 1097149. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Align Technology, Inc. have?
Align Technology, Inc. has 15 FDA 510(k) clearances (first 1998, latest 2026), across 2 product codes in 1 review panel.
How long does FDA take to clear Align Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Align Technology, Inc.'s cleared 510(k)s is 81 days. Since 2017: 63 days, versus 128 days for all cleared 510(k)s in the same product codes.
What devices does Align Technology, Inc. make?
Its most frequent FDA product codes are NXC (Aligner, Sequential, 12); NTK (Light Transmission Caries Detector, 3).
Has Align Technology, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Align Technology, Inc; the most recent began 2022-12-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 15 Align Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NXC, Align Technology, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.