FDA applicant
Align Technology, Inc.
FDA records 16 decisions for Align Technology, Inc. (San Jose, CA) from 1998 to 2026: 16 510(k) clearances. Most are in product codes NXC (Aligner, Sequential) and NTK (Light Transmission Caries Detector). Since 2016 its 510(k)s took a median of 63 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 14 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Align Technology”, “Align Technology , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Align Technology, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Align Technology, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report