Cleared Traditional

K192119 - 3M Clarity Aligners

K192119 is the FDA 510(k) clearance for 3M Clarity Aligners by 3M Company. It is a Class 2 Dental device (product code NXC) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K192119 · 3M Company · Dental device
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Sep 2019
Decision
30d
Days
Class 2
Risk

K192119 is an FDA 510(k) clearance for the 3M Clarity Aligners. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by 3M Company (Saint Paul, US). The FDA issued a Cleared decision on September 5, 2019 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

Submission Details

510(k) Number K192119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2019
Decision Date September 05, 2019
Days to Decision 30 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
97d faster than avg
Panel avg: 127d · This submission: 30d
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 K192119.
SunClear Aligner system
K190394 · Sun Dental Laboratories, LLC · Dec 2019
Vivid Aligners
K190003 · Orthodent Laboratory, Inc. · Nov 2019
SmileAlign Orthodontic Aligner System
K191774 · 3D Global Biotech, Inc. · Sep 2019
OSW Aligner System
K191990 · Osw Manufacturing, LLC · Aug 2019
DynaFlex
K190583 · Dyna Flex · Jun 2019
Bioliner
K182658 · Five Star Orthodontic Lab & Supply · Jun 2019