Cleared Special

NEOLab Clear Aligners (K203339) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K203339 · New England Ortho Lab, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2021
Decision
55d
Days
Class 2
Risk

K203339 is an FDA 510(k) clearance for the NEOLab Clear Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by New England Ortho Lab, Inc. (Andover, US). The FDA issued a Cleared decision on January 6, 2021 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all New England Ortho Lab, Inc. devices

Submission Details

510(k) Number K203339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2020
Decision Date January 06, 2021
Days to Decision 55 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 127d · This submission: 55d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K203339.
Archworx
K173738 · Utah Medical Products and Services · Feb 2021
AsoAligner
K201104 · Aso International Manila, Inc. · Feb 2021
BRIUS Clear Aligners
K202792 · Brius Technologies, Inc. · Jan 2021
ClearPath Aligner
K202857 · Clearpath Orthodontics, Ltd. · Jan 2021
iSMILE
K200908 · 3D Diagnostix, Inc. · Dec 2020
TP Orthodontics Clear Aligner System
K193385 · Tp Orthodontics, Inc. · Nov 2020