Cleared Traditional

K191838 - Clearform Aligners

K191838 is the FDA 510(k) clearance for Clearform Aligners by Motor City Lab Works. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K191838 · Motor City Lab Works · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
255d
Days
Class 2
Risk

K191838 is an FDA 510(k) clearance for the Clearform Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Motor City Lab Works (Birmingham, US). The FDA issued a Cleared decision on March 20, 2020 after a review of 255 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 Motor City Lab Works devices

Submission Details

510(k) Number K191838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date March 20, 2020
Days to Decision 255 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
128d slower than avg
Panel avg: 127d · This submission: 255d
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

Aclivi, LLC
Chris Brown

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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K191838.
Arcad SmileStudio and Aligner System
K192244 · Arcadlab · May 2020
Aerodentis System
K192069 · Dror Orthodesign · May 2020
U-Aligner
K191308 · Universal Orthodontic Laboratory, Inc. · Apr 2020
NEOLab Clear Aligners
K192338 · New England Ortho Lab, Inc. · Mar 2020
3D Predict
K200214 · 3D Smile USA, Inc. · Feb 2020
ULab Systems Dental Aligner Kit
K192596 · Ulab Systems, Inc. · Feb 2020