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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corporation. It received FDA 510(k) clearance on 2021-03-22 under 510(k) 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. The listed applicant is Ormco Corporation. The 510(k) number is K203737.

When did Spark Clear Aligner System receive FDA 510(k) clearance?

Spark Clear Aligner System received FDA 510(k) clearance on 2021-03-22, under 510(k) number K203737.

Who is the listed applicant for Spark Clear Aligner System?

The FDA 510(k) record lists Ormco Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spark Clear Aligner System?

The FDA product code for Spark Clear Aligner System is NXC.

Other records listing Ormco Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250487SparkTM Clear Aligner SystemK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveK240501Spark™ Clear Aligner SystemK172845Symetri ClearK171844Inspire ICE aka Inspire ICE Clear Brackets

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

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.

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