Cleared Special

LuxCreo Clear Aligner System

K250343 · LuxCreo, Inc. · Dental
Apr 2025
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K250343 is an FDA 510(k) clearance for the LuxCreo Clear Aligner System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by LuxCreo, Inc. (Chicago, US). The FDA issued a Cleared decision on April 8, 2025, 61 days after receiving the submission on February 6, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K250343 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NXC — Aligner, Sequential
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.