Align Technology, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Align Technology, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Invisalign® Palatal Expander System, Invisalign Specifix Attachment System, Invisalign System
11
Total
11
Cleared
0
Denied
Align Technology, Inc. has 11 FDA 510(k) cleared dental devices. Based in San Jose, US.
Latest FDA clearance: Oct 2025. Active since 2015.
Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Hogan Lovells US LLP as regulatory consultant.
FDA 510(k) Regulatory Record - Align Technology, Inc.
11 devices
Cleared
Oct 23, 2025
Invisalign® Palatal Expander System
Dental
38d
Cleared
Oct 09, 2025
Invisalign Specifix Attachment System
Dental
30d
Cleared
Aug 29, 2025
Invisalign System
Dental
30d
Cleared
Jun 18, 2024
Invisalign System
Dental
32d
Cleared
Dec 15, 2023
Invisalign Palatal Expander System
Dental
88d
Cleared
Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Dental
61d
Cleared
Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
Dental
90d
Cleared
Apr 07, 2022
Invisalign System
Dental
65d
Cleared
Mar 20, 2020
iTero Element 5D
Dental
81d
Cleared
Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
Dental
116d
Cleared
Nov 18, 2015
Invisalign System
Dental
331d