Cleared Traditional

K192470 - DenMat Orthodontic Aligners

K192470 is the FDA 510(k) clearance for DenMat Orthodontic Aligners by Denmat Holdings, LLC. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K192470 · Denmat Holdings, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
102d
Days
Class 2
Risk

K192470 is an FDA 510(k) clearance for the DenMat Orthodontic Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Denmat Holdings, LLC (Lompoc, US). The FDA issued a Cleared decision on December 20, 2019 after a review of 102 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. 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 Denmat Holdings, LLC devices

Submission Details

510(k) Number K192470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2019
Decision Date December 20, 2019
Days to Decision 102 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Regulatory Technology Services, LLC
Prithul Bom

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 K192470.
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
Krystal Klear Aligners
K182388 · Shatkin F.I.R.S.T., LLC · Dec 2019
SunClear Aligner system
K190394 · Sun Dental Laboratories, LLC · Dec 2019
Vivid Aligners
K190003 · Orthodent Laboratory, Inc. · Nov 2019