FDA 510(k)

U-Aligner

K-Number: K191308 · 2020-04-23

ApplicantUniversal Orthodontic Laboratory, Inc.

Decision Date2020-04-23

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

U-Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Universal Orthodontic Laboratory, Inc.. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K191308. 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 U-Aligner?

U-Aligner is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Universal Orthodontic Laboratory, Inc.. The 510(k) number is K191308.

When did U-Aligner receive FDA 510(k) clearance?

U-Aligner received FDA 510(k) clearance on 2020-04-23, under 510(k) number K191308.

Who is the listed applicant for U-Aligner?

The FDA 510(k) record lists Universal Orthodontic Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U-Aligner?

The FDA product code for U-Aligner 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.