Cleared Special

K252931 - Invisalign® Palatal Expander System (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252931 · Align Technology, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
38d
Days
Class 2
Risk

K252931 is an FDA 510(k) clearance for the Invisalign® Palatal Expander System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on October 23, 2025 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Align Technology, Inc. devices

Submission Details

510(k) Number K252931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2025
Decision Date October 23, 2025
Days to Decision 38 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 127d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 142
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K252931.
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
Invisalign Specifix Attachment System
K252870 · Align Technology, Inc. · Oct 2025
Serafin®
K251758 · Tns Co., Ltd. · Sep 2025