Cleared Special

Invisalign System

K220287 · Align Technology, Inc. · Dental
Apr 2022
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K220287 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 April 7, 2022, 65 days after receiving the submission on February 1, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K220287 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2022
Decision Date April 07, 2022
Days to Decision 65 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.