Cleared Traditional

LuxCreo Clear Aligner System

K212680 · LuxCreo, Inc. · Dental
May 2022
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K212680 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. (Belmont, US). The FDA issued a Cleared decision on May 31, 2022, 280 days after receiving the submission on August 24, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K212680 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2021
Decision Date May 31, 2022
Days to Decision 280 days
Submission Type Traditional
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.