Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Align Technology and its 2 subsidiaries with 20 510(k) clearances and 2 device recalls. The most recent is a 510(k) clearance dated Sep 25, 2026: Invisalign System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Align Technology and its 2 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Sep 25, 2026 | Invisalign SystemK262196 · PNN | 510(k) clearances |
| Jul 2, 2026 | iTero Lumina™ ProK261847 · NTK | 510(k) clearances |
| Oct 23, 2025 | Invisalign® Palatal Expander SystemK252931 · NXC | 510(k) clearances |
| Oct 9, 2025 | Invisalign Specifix Attachment SystemK252870 · NXC | 510(k) clearances |
| Aug 29, 2025 | Invisalign SystemK252380 · NXC | 510(k) clearances |
| Aug 16, 2024 | iTero Lumina™ ProK240573 · NTK | 510(k) clearances |
| Jun 18, 2024 | Invisalign SystemK241412 · NXC | 510(k) clearances |
| Dec 15, 2023 | Invisalign Palatal Expander SystemK232887 · NXC | 510(k) clearances |
| Aug 17, 2023 | exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualiClass II · A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Pro | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
