Cleared Traditional

Spark Clear Aligner System (K203737) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203737 · Ormco Corporation · Dental device
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Mar 2021
Decision
90d
Days
Class 2
Risk

K203737 is an FDA 510(k) clearance for the Spark Clear Aligner System. Classified as Aligner, Sequential (product code NXC), Class II - Special Controls.

Submitted by Ormco Corporation (Brea, US). The FDA issued a Cleared decision on March 22, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5470 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ormco Corporation devices

Submission Details

510(k) Number K203737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NXC Aligner, Sequential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5470
Definition The Device Moves The Teeth By Continuous Gentle Force For Treatment Of Minor Tooth Malocclusion.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NXC Aligner, Sequential

All 123
Devices cleared under the same product code (NXC) and FDA review panel - the closest regulatory comparables to K203737.
Ohlendorf Clear Aligner
K210540 · Ohlendorf Appliance Laboratory · May 2021
Illusion Aligners
K211010 · Laxmi Dental Exports Pvt, Ltd. · Apr 2021
3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex)
K211190 · 3M Company, Unitek Orthodontic Products · Apr 2021
Archworx
K173738 · Utah Medical Products and Services · Feb 2021
AsoAligner
K201104 · Aso International Manila, Inc. · Feb 2021
BRIUS Clear Aligners
K202792 · Brius Technologies, Inc. · Jan 2021