Cleared Traditional

Invisalign System with Mandibular Advancement Feature

K181739 · Align Technology, Inc. · Dental

Oct 2018

Decision

116d

Days

Class 2

Risk

About This 510(k) Submission

K181739 is an FDA 510(k) clearance for the Invisalign System with Mandibular Advancement Feature, 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 October 26, 2018, 116 days after receiving the submission on July 2, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K181739 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 02, 2018
Decision Date	October 26, 2018
Days to Decision	116 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.