Cleared Traditional

3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) (K211190) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211190 · 3M Company, Unitek Orthodontic Products · Dental device
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Apr 2021
Decision
2d
Days
Class 2
Risk

K211190 is an FDA 510(k) clearance for the 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex). Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by 3M Company, Unitek Orthodontic Products (Saint Paul, US). The FDA issued a Cleared decision on April 23, 2021 after a review of 2 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, Unitek Orthodontic Products devices

Submission Details

510(k) Number K211190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2021
Decision Date April 23, 2021
Days to Decision 2 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
125d faster than avg
Panel avg: 127d · This submission: 2d
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 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K211190.
6MS Invisible Aligner
K210652 · Sms Opco, LLC · Jun 2021
Ohlendorf Clear Aligner
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Illusion Aligners
K211010 · Laxmi Dental Exports Pvt, Ltd. · Apr 2021
Spark Clear Aligner System
K203737 · Ormco Corporation · Mar 2021
Archworx
K173738 · Utah Medical Products and Services · Feb 2021
AsoAligner
K201104 · Aso International Manila, Inc. · Feb 2021