FDA 510(k)

Ensmile

K-Number: K222619 · 2023-03-16

Decision Date2023-03-16

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Ensmile is the device name listed in this FDA 510(k) record. The listed applicant is Ensmile Pvt, Ltd.. It received FDA 510(k) clearance on 2023-03-16 under 510(k) number K222619. 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 Ensmile?

Ensmile is a medical device that received FDA 510(k) clearance on 2023-03-16. The listed applicant is Ensmile Pvt, Ltd.. The 510(k) number is K222619.

When did Ensmile receive FDA 510(k) clearance?

Ensmile received FDA 510(k) clearance on 2023-03-16, under 510(k) number K222619.

Who is the listed applicant for Ensmile?

The FDA 510(k) record lists Ensmile Pvt, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ensmile?

The FDA product code for Ensmile 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.