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FDA 510(k)

Spark™ Clear Aligner System

K-Number: K240501 · 2024-10-11

ApplicantOrmco Corporation
Decision Date2024-10-11
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 2024-10-11 under 510(k) number K240501. 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 2024-10-11. The listed applicant is Ormco Corporation. The 510(k) number is K240501.

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

Spark™ Clear Aligner System received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240501.

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 AdhesiveK203737Spark 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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