Cleared Traditional

Invisalign Palatal Expander System

K232887 · Align Technology, Inc. · Dental
Dec 2023
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K232887 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 December 15, 2023, 88 days after receiving the submission on September 18, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K232887 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 2023
Decision Date December 15, 2023
Days to Decision 88 days
Submission Type Traditional
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.