Cleared Traditional

K191308 - U-Aligner

K191308 is the FDA 510(k) clearance for U-Aligner by Universal Orthodontic Laboratory, Inc.. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K191308 · Universal Orthodontic Laboratory, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
345d
Days
Class 2
Risk

K191308 is an FDA 510(k) clearance for the U-Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Universal Orthodontic Laboratory, Inc. (Norwalk, US). The FDA issued a Cleared decision on April 23, 2020 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Universal Orthodontic Laboratory, Inc. devices

Submission Details

510(k) Number K191308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2019
Decision Date April 23, 2020
Days to Decision 345 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
218d slower than avg
Panel avg: 127d · This submission: 345d
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 Peers - NXC Aligner, Sequential

All 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K191308.
MVP Aligner System
K193130 · Mvp Aligners, LLC · Aug 2020
Arcad SmileStudio and Aligner System
K192244 · Arcadlab · May 2020
Aerodentis System
K192069 · Dror Orthodesign · May 2020
Clearform Aligners
K191838 · Motor City Lab Works · Mar 2020
NEOLab Clear Aligners
K192338 · New England Ortho Lab, Inc. · Mar 2020
3D Predict
K200214 · 3D Smile USA, Inc. · Feb 2020