SparkTM Clear Aligner System
K-Number: K250487 · 2025-02-20
ApplicantOrmco Corporation
Decision Date2025-02-20
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
SparkTM Clear Aligner System is a medical device manufactured by Ormco Corporation. It received FDA 510(k) clearance on 2025-02-20 under approval number K250487. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SparkTM Clear Aligner System?
SparkTM Clear Aligner System is a medical device that received FDA 510(k) clearance on 2025-02-20. It is manufactured by Ormco Corporation. The 510(k) number is K250487.
When was SparkTM Clear Aligner System approved by the FDA?
SparkTM Clear Aligner System received FDA 510(k) clearance on 2025-02-20, under approval number K250487.
What company makes SparkTM Clear Aligner System?
SparkTM Clear Aligner System is manufactured by Ormco Corporation.
What is the FDA product code for SparkTM Clear Aligner System?
The FDA product code for SparkTM Clear Aligner System is NXC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.