Cleared Traditional

K263860 - Shining3D Clear Aligner System

K263860 is an FDA 510(k) clearance for Shining3D Clear Aligner System, manufactured by Hangzhou SHINING3D Dental Technology Co., Ltd.. The device is a Class 2 Dental device with product code NXC cleared through the Traditional 510(k) pathway after a 1-day FDA review.

K263860 · Hangzhou SHINING3D Dental Technology Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
1d
Days
Class 2
Risk

K263860 is an FDA 510(k) clearance for the Shining3D Clear Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Hangzhou SHINING3D Dental Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 30, 2026 after a review of 1 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 - K263860

510(k) Number K263860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2026
Decision Date October 30, 2026
Days to Decision 1 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
127d faster than avg
Panel avg: 128d · This submission: 1d
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

Third Party Review Group, LLC
Dave Yungvirt

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 145
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K263860.
FACE4D Aligner
K260527 · Avinent Implant System S.L.U. · Jul 2026
Smylio Aligners
K260788 · Smylio, Inc. · May 2026
SureSmile Aligner (ASSY500020)
K260722 · Dentsply Sirona, Inc. · Apr 2026
ZSmile System
K253282 · Dror Orthodesign , Ltd. · Feb 2026
Clear Aligner (SCF-3348)
K251454 · Beame Medical Technology (Shenzhen) Limited · Jan 2026
Primeprint Direct Aligner
K250739 · Dreve Dentamid GmbH · Nov 2025
K263860 · Shining3D Clear Aligner System
Download PDF FDA Summary Hangzhou SHINING3D De…