Cleared Traditional

K163689 - 3M Clear Tray Aligner

K163689 is an FDA 510(k) clearance for 3M Clear Tray Aligner, manufactured by 3M Unitek Corporation. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K163689 · 3M Unitek Corporation · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
30d
Days
Class 2
Risk

K163689 is an FDA 510(k) clearance for the 3M Clear Tray Aligner. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by 3M Unitek Corporation (Monrovia, US). The FDA issued a Cleared decision on January 27, 2017 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.

FDA 510(k) Submission Details - K163689

510(k) Number K163689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2016
Decision Date January 27, 2017
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
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

NXC Device Classification - Class 2, Special Controls

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 144
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K163689.
Sureclear aligners
K171860 · Emergo Global Consulting, LLC · Jan 2018
ClearPath Aligner
K162609 · Clearpath Orthodontics, Ltd. · Jul 2017
MTM Clear Aligner
K163155 · Dentsply Sirona · Feb 2017
Dentti System
K151965 · Martz, Inc. · Mar 2016
Invisalign System
K143630 · Align Technology, Inc. · Nov 2015
eCligner
K143499 · Eclear International Co., Ltd. · Oct 2015