Cleared Special

LuxCreo Clear Aligner System (K250343) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K250343 · LuxCreo, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
61d
Days
Class 2
Risk

K250343 is an FDA 510(k) clearance for the LuxCreo Clear Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by LuxCreo, Inc. (Chicago, US). The FDA issued a Cleared decision on April 8, 2025 after a review of 61 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all LuxCreo, Inc. devices

Submission Details

510(k) Number K250343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2025
Decision Date April 08, 2025
Days to Decision 61 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 127d · This submission: 61d
Pathway characteristics
Modification to existing cleared device.

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 Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K250343.
Additively Manufactured Aligner Resin
K251415 · Aidite (Qinhuangdao) Technology Co., Ltd. · Aug 2025
Clear Miracle
K251616 · Ods Co., Ltd. · Jul 2025
MEM Clear Aligner System
K242637 · Mem Dental Technology Co., Ltd. · May 2025
SparkTM Clear Aligner System
K250487 · Ormco Corporation · Feb 2025
Pearl Clear Aligner
K242715 · Pearl Digital, Inc. · Jan 2025
Fas Aligner System
K242929 · Xplora 3D Europe S.L · Dec 2024