Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Align Technology, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
116 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252931 | Invisalign® Palatal Expander System | Align Technology, Inc. | 2025-10-23 | 38 | 0 |
| K252870 | Invisalign Specifix Attachment System | Align Technology, Inc. | 2025-10-09 | 30 | 0 |
| K252380 | Invisalign System | Align Technology, Inc. | 2025-08-29 | 30 | 0 |
| K241412 | Invisalign System | Align Technology, Inc. | 2024-06-18 | 32 | 0 |
| K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | 2023-12-15 | 88 | 0 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occl | Align Technology, Inc. | 2023-09-26 | 61 | 0 |
| K222894 | Invisalign System, Pre-Formed Attachment System | Align Technology, Inc. | 2022-12-22 | 90 | 0 |
| K220287 | Invisalign System | Align Technology, Inc. | 2022-04-07 | 65 | 1 |
| K193659 | iTero Element 5D | Align Technology, Inc. | 2020-03-20 | 81 | 0 |
| K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | 2018-10-26 | 116 | 0 |
| K143630 | Invisalign System | Align Technology, Inc. | 2015-11-18 | 331 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda