Cleared Traditional

NEOLab Clear Aligners (K192338) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192338 · New England Ortho Lab, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
197d
Days
Class 2
Risk

K192338 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 March 12, 2020 after a review of 197 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all New England Ortho Lab, Inc. devices

Submission Details

510(k) Number K192338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2019
Decision Date March 12, 2020
Days to Decision 197 days
Submission Type Traditional
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
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Qserve Group, Us, Inc.
Patsy J Trisler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K192338.
Aerodentis System
K192069 · Dror Orthodesign · May 2020
U-Aligner
K191308 · Universal Orthodontic Laboratory, Inc. · Apr 2020
Clearform Aligners
K191838 · Motor City Lab Works · Mar 2020
3D Predict
K200214 · 3D Smile USA, Inc. · Feb 2020
ULab Systems Dental Aligner Kit
K192596 · Ulab Systems, Inc. · Feb 2020
Argen Clear Aligner, Argen Clear Aligner Premium
K192846 · Argen Corporation · Feb 2020