Cleared Traditional

K193130 - MVP Aligner System

K193130 is the FDA 510(k) clearance for MVP Aligner System by Mvp Aligners, LLC. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K193130 · Mvp Aligners, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
269d
Days
Class 2
Risk

K193130 is an FDA 510(k) clearance for the MVP Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Mvp Aligners, LLC (New York, US). The FDA issued a Cleared decision on August 7, 2020 after a review of 269 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 Mvp Aligners, LLC devices

Submission Details

510(k) Number K193130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2019
Decision Date August 07, 2020
Days to Decision 269 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
142d slower than avg
Panel avg: 127d · This submission: 269d
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 K193130.
Concinnity Aligners
K200005 · Drake Precision Dental Laboratory, Inc. · Nov 2020
Eon Aligner
K202685 · Eon Dental Jordan, LLC · Sep 2020
Straight T Clear Dental Aligner
K201450 · Straight T, Inc. · Sep 2020
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