Cleared Traditional

Invisalign System, Pre-Formed Attachment System

K222894 · Align Technology, Inc. · Dental
Dec 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K222894 is an FDA 510(k) clearance for the Invisalign System, Pre-Formed Attachment 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 22, 2022, 90 days after receiving the submission on September 23, 2022. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K222894 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date December 22, 2022
Days to Decision 90 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.