Cleared Traditional

K192244 - Arcad SmileStudio and Aligner System

K192244 is the FDA 510(k) clearance for Arcad SmileStudio and Aligner System by Arcadlab. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K192244 · Arcadlab · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2020
Decision
266d
Days
Class 2
Risk

K192244 is an FDA 510(k) clearance for the Arcad SmileStudio and Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Arcadlab (West Palm Beach, US). The FDA issued a Cleared decision on May 11, 2020 after a review of 266 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 Arcadlab devices

Submission Details

510(k) Number K192244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2019
Decision Date May 11, 2020
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 126
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K192244.
Eon Aligner
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MVP Aligner System
K193130 · Mvp Aligners, LLC · Aug 2020
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