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FDA 510(k)

TRIOCLEAR System

K-Number: K193622 · 2021-07-06

ApplicantPerfection Aligner System Hong Kong Limited
Decision Date2021-07-06
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIOCLEAR System is the device name listed in this FDA 510(k) record. The listed applicant is Perfection Aligner System Hong Kong Limited. It received FDA 510(k) clearance on 2021-07-06 under 510(k) number K193622. 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 TRIOCLEAR System?

TRIOCLEAR System is a medical device that received FDA 510(k) clearance on 2021-07-06. The listed applicant is Perfection Aligner System Hong Kong Limited. The 510(k) number is K193622.

When did TRIOCLEAR System receive FDA 510(k) clearance?

TRIOCLEAR System received FDA 510(k) clearance on 2021-07-06, under 510(k) number K193622.

Who is the listed applicant for TRIOCLEAR System?

The FDA 510(k) record lists Perfection Aligner System Hong Kong Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIOCLEAR System?

The FDA product code for TRIOCLEAR System is NXC.

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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