Cleared Special

Invisalign? Palatal Expander System

K252931 · Align Technology, Inc. · Dental

Oct 2025

Decision

38d

Days

Class 2

Risk

About This 510(k) Submission

K252931 is an FDA 510(k) clearance for the Invisalign? Palatal Expander System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Align Technology, Inc. (San Jose, US). The FDA issued a Cleared decision on October 23, 2025, 38 days after receiving the submission on September 15, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K252931 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	NXC — Aligner, Sequential
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.