Cleared Traditional

K183159 - 3M Clarity Aligners

K183159 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 11-day FDA review.

K183159 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
11d
Days
Class 2
Risk

K183159 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 November 26, 2018 after a review of 11 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 K183159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2018
Decision Date November 26, 2018
Days to Decision 11 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
116d faster than avg
Panel avg: 127d · This submission: 11d
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
MARK JOB

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 K183159.
Byte Aligner System
K180346 · Straight Smile, LLC · Feb 2019
Park Dental Research Aligners
K180648 · Park Dental Research Corporation · Jan 2019
Clear Image Aligners
K183643 · Specialty Appliance Works, Inc. · Jan 2019
SureCure Orthodontic Aligner System
K182329 · Digital Orthodontic Care · Nov 2018
Invisalign System with Mandibular Advancement Feature
K181739 · Align Technology, Inc. · Oct 2018
Ormco Spark Aligner System
K182826 · Sybron Dental Specialties · Oct 2018