Cleared Special

Argen Clear Aligner, Argen Clear Aligner Premium (K192846) - FDA 510(k) Clearance

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

K192846 · Argen Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2020
Decision
130d
Days
Class 2
Risk

K192846 is an FDA 510(k) clearance for the Argen Clear Aligner, Argen Clear Aligner Premium. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Argen Corporation (San Diego, US). The FDA issued a Cleared decision on February 10, 2020 after a review of 130 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Argen Corporation devices

Submission Details

510(k) Number K192846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2019
Decision Date February 10, 2020
Days to Decision 130 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
3d slower than avg
Panel avg: 127d · This submission: 130d
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 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 K192846.
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
UniSmile Clear Aligner System
K191837 · Vitang Technology, LLC · Jan 2020
Clear Aligner
K192767 · Royal Dental Lab · Jan 2020
Clear-Aligners
K191823 · Cdb Corporation · Dec 2019