Cleared Traditional

Invisalign System with Mandibular Advancement Featuring Occlusal Blocks

K232233 · Align Technology, Inc. · Dental
Sep 2023
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K232233 is an FDA 510(k) clearance for the Invisalign System with Mandibular Advancement Featuring Occlusal Blocks, 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 September 26, 2023, 61 days after receiving the submission on July 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K232233 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2023
Decision Date September 26, 2023
Days to Decision 61 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.