Spark Clear Aligner System
K-Number: K203737 · 2021-03-22
ApplicantOrmco Corporation
Decision Date2021-03-22
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Spark Clear Aligner System is a medical device manufactured by Ormco Corporation. It received FDA 510(k) clearance on 2021-03-22 under approval number K203737. 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 Spark Clear Aligner System?
Spark Clear Aligner System is a medical device that received FDA 510(k) clearance on 2021-03-22. It is manufactured by Ormco Corporation. The 510(k) number is K203737.
When was Spark Clear Aligner System approved by the FDA?
Spark Clear Aligner System received FDA 510(k) clearance on 2021-03-22, under approval number K203737.
What company makes Spark Clear Aligner System?
Spark Clear Aligner System is manufactured by Ormco Corporation.
What is the FDA product code for Spark Clear Aligner System?
The FDA product code for Spark 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.