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FDA 510(k)

Ensmile

K-Number: K222619 · 2023-03-16

ApplicantEnsmile Pvt, Ltd.
Decision Date2023-03-16
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ensmile is a medical device manufactured by Ensmile Pvt, Ltd.. It received FDA 510(k) clearance on 2023-03-16 under approval 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. It is manufactured by Ensmile Pvt, Ltd.. The 510(k) number is K222619.

When was Ensmile approved by the FDA?

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

What company makes Ensmile?

Ensmile is manufactured by Ensmile Pvt, Ltd..

What is the FDA product code for Ensmile?

The FDA product code for Ensmile is NXC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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