FDA 510(k)

UniSmile Clear Aligner System

K-Number: K191837 · 2020-01-29

Decision Date2020-01-29

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UniSmile Clear Aligner System is the device name listed in this FDA 510(k) record. The listed applicant is Vitang Technology, LLC. It received FDA 510(k) clearance on 2020-01-29 under 510(k) number K191837. 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 UniSmile Clear Aligner System?

UniSmile Clear Aligner System is a medical device that received FDA 510(k) clearance on 2020-01-29. The listed applicant is Vitang Technology, LLC. The 510(k) number is K191837.

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

UniSmile Clear Aligner System received FDA 510(k) clearance on 2020-01-29, under 510(k) number K191837.

Who is the listed applicant for UniSmile Clear Aligner System?

The FDA 510(k) record lists Vitang Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for UniSmile Clear Aligner 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) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.