Cleared Special

Invisalign System

K252380 · Align Technology, Inc. · Dental
Aug 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K252380 is an FDA 510(k) clearance for the Invisalign 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 August 29, 2025, 30 days after receiving the submission on July 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K252380 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2025
Decision Date August 29, 2025
Days to Decision 30 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.