FDA 510(k)

Sureclear aligners

K-Number: K171860 · 2018-01-05

Decision Date2018-01-05

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Sureclear aligners is the device name listed in this FDA 510(k) record. The listed applicant is Emergo Global Consulting, LLC. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K171860. 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 Sureclear aligners?

Sureclear aligners is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Emergo Global Consulting, LLC. The 510(k) number is K171860.

When did Sureclear aligners receive FDA 510(k) clearance?

Sureclear aligners received FDA 510(k) clearance on 2018-01-05, under 510(k) number K171860.

Who is the listed applicant for Sureclear aligners?

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

What is the FDA product code for Sureclear aligners?

The FDA product code for Sureclear aligners 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.