Cleared Traditional

Spark? Clear Aligner System

K240501 · Ormco Corporation · Dental
Oct 2024
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K240501 is an FDA 510(k) clearance for the Spark? Clear Aligner System, a Aligner, Sequential (Class II — Special Controls, product code NXC), submitted by Ormco Corporation (Brea, US). The FDA issued a Cleared decision on October 11, 2024, 233 days after receiving the submission on February 21, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K240501 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2024
Decision Date October 11, 2024
Days to Decision 233 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.