Cleared Traditional

Spark Clear Aligner System

K203737 · Ormco Corporation · Dental

Mar 2021

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K203737 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 March 22, 2021, 90 days after receiving the submission on December 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K203737 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2020
Decision Date	March 22, 2021
Days to Decision	90 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.