ClearanceBrief
Company · US

Align Technology, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.

16510(k) clearances (2 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)

Product codes

CodeDeviceRecords
NXCAligner, Sequential12
NTKLight Transmission Caries Detector3
PNNOrthodontic Software2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 25, 2026K262196Invisalign System
Align Technology, Inc.
PNN
Jul 2, 2026K261847iTero Lumina™ Pro
Align Technology , Ltd., IL
NTK
Oct 23, 2025K252931Invisalign® Palatal Expander System
Align Technology, Inc.
NXC
Oct 9, 2025K252870Invisalign Specifix Attachment System
Align Technology, Inc.
NXC
Aug 29, 2025K252380Invisalign System
Align Technology, Inc.
NXC
Aug 16, 2024K240573iTero Lumina™ Pro
Align Technology , Ltd., IL
NTK
Jun 18, 2024K241412Invisalign System
Align Technology, Inc.
NXC
Dec 15, 2023K232887Invisalign Palatal Expander System
Align Technology, Inc.
NXC
Sep 26, 2023K232233Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
Align Technology, Inc.
NXC
Dec 22, 2022K222894Invisalign System, Pre-Formed Attachment System
Align Technology, Inc.
NXC
Apr 7, 2022K220287Invisalign System
Align Technology, Inc.
NXC
Mar 20, 2020K193659iTero Element 5D
Align Technology, Inc.
NTK
Oct 26, 2018K181739Invisalign System with Mandibular Advancement Feature
Align Technology, Inc.
NXC
Nov 18, 2015K143630Invisalign System
Align Technology, Inc.
NXC
Dec 17, 2008K081960INVISALIGN SYSTEM
Align Technology
NXC
Sep 8, 1998K981095ALIGN SYSTEM
Align Technology
NXC

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 26, 2023Align Technology Inc
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Completed		 PNNK220287
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