Medical Device Manufacturer · US , San Jose , CA

Align Technology, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2015

Recent clearances: Invisalign System, Invisalign® Palatal Expander System, Invisalign Specifix Attachment System

12
Total
12
Cleared
0
Denied

FDA 510(k) Regulatory Record - Align Technology, Inc. Dental ✕

12 devices
1-12 of 12
Cleared Sep 25, 2026
Invisalign System
K262196 · PNN
Dental · 88d
Cleared Oct 23, 2025
Invisalign® Palatal Expander System
K252931 · NXC
Dental · 38d
Cleared Oct 09, 2025
Invisalign Specifix Attachment System
K252870 · NXC
Dental · 30d
Cleared Aug 29, 2025
Invisalign System
K252380 · NXC
Dental · 30d
Cleared Jun 18, 2024
Invisalign System
K241412 · NXC
Dental · 32d
Cleared Dec 15, 2023
Invisalign Palatal Expander System
K232887 · NXC
Dental · 88d
Cleared Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
K232233 · NXC
Dental · 61d
Cleared Dec 22, 2022
Invisalign System, Pre-Formed Attachment System
K222894 · NXC
Dental · 90d
Cleared Apr 07, 2022
Invisalign System
K220287 · NXC
Dental · 65d
Cleared Mar 20, 2020
iTero Element 5D
K193659 · NTK
Dental · 81d
Cleared Oct 26, 2018
Invisalign System with Mandibular Advancement Feature
K181739 · NXC
Dental · 116d
Cleared Nov 18, 2015
Invisalign System
K143630 · NXC
Dental · 331d
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