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FDA 510(k)

Nightwear Aligners

K-Number: K221537 · 2023-04-05

ApplicantSmylio, Inc.
Decision Date2023-04-05
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Nightwear Aligners is a medical device manufactured by Smylio, Inc.. It received FDA 510(k) clearance on 2023-04-05 under approval number K221537. 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 Nightwear Aligners?

Nightwear Aligners is a medical device that received FDA 510(k) clearance on 2023-04-05. It is manufactured by Smylio, Inc.. The 510(k) number is K221537.

When was Nightwear Aligners approved by the FDA?

Nightwear Aligners received FDA 510(k) clearance on 2023-04-05, under approval number K221537.

What company makes Nightwear Aligners?

Nightwear Aligners is manufactured by Smylio, Inc..

What is the FDA product code for Nightwear Aligners?

The FDA product code for Nightwear Aligners is NXC.

Other Devices by Smylio, Inc.

K173784Smylic Invisible Clear Aligners K212660Smylio Invisible Clear Aligners K260788Smylio Aligners

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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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