FDA 510(k)

6MS Invisible Aligner

K-Number: K210652 · 2021-06-02

Decision Date2021-06-02

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

6MS Invisible Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Sms Opco, LLC. It received FDA 510(k) clearance on 2021-06-02 under 510(k) number K210652. 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 6MS Invisible Aligner?

6MS Invisible Aligner is a medical device that received FDA 510(k) clearance on 2021-06-02. The listed applicant is Sms Opco, LLC. The 510(k) number is K210652.

When did 6MS Invisible Aligner receive FDA 510(k) clearance?

6MS Invisible Aligner received FDA 510(k) clearance on 2021-06-02, under 510(k) number K210652.

Who is the listed applicant for 6MS Invisible Aligner?

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

What is the FDA product code for 6MS Invisible Aligner?

The FDA product code for 6MS Invisible 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.