FDA 510(k)

3M Clear Tray Aligner

K-Number: K163689 · 2017-01-27

Decision Date2017-01-27

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

3M Clear Tray Aligner is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek Corporation. It received FDA 510(k) clearance on 2017-01-27 under 510(k) number K163689. 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 3M Clear Tray Aligner?

3M Clear Tray Aligner is a medical device that received FDA 510(k) clearance on 2017-01-27. The listed applicant is 3M Unitek Corporation. The 510(k) number is K163689.

When did 3M Clear Tray Aligner receive FDA 510(k) clearance?

3M Clear Tray Aligner received FDA 510(k) clearance on 2017-01-27, under 510(k) number K163689.

Who is the listed applicant for 3M Clear Tray Aligner?

The FDA 510(k) record lists 3M Unitek Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M Clear Tray Aligner?

The FDA product code for 3M Clear Tray 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.