Cleared Traditional

SparkTM Clear Aligner System

K250487 · Ormco Corporation · Dental
Feb 2025
Decision
1d
Days
Class 2
Risk

About This 510(k) Submission

K250487 is an FDA 510(k) clearance for the SparkTM 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 February 20, 2025, 1 days after receiving the submission on February 19, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K250487 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2025
Decision Date February 20, 2025
Days to Decision 1 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.