Align Technology, Inc.
Align Technology, Inc. holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2025, with 1 FDA device recall on record.
Top product codes for Align Technology, Inc.
FDA recalls by Align Technology, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Align Technology, Inc.
- K252931 — Invisalign® Palatal Expander System
- K252870 — Invisalign Specifix Attachment System
- K252380 — Invisalign System
- K241412 — Invisalign System
- K232887 — Invisalign Palatal Expander System
- K232233 — Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
- K222894 — Invisalign System, Pre-Formed Attachment System
- K220287 — Invisalign System
- K193659 — iTero Element 5D
- K181739 — Invisalign System with Mandibular Advancement Feature
- K143630 — Invisalign System
Data sourced from openFDA. This site is unofficial and independent of the FDA.