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FDA 510(k)

Smylio Aligners

K-Number: K260788 · 2026-05-08

ApplicantSmylio, Inc.
Decision Date2026-05-08
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Smylio Aligners is a medical device manufactured by Smylio, Inc.. It received FDA 510(k) clearance on 2026-05-08 under approval number K260788. 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 Smylio Aligners?

Smylio Aligners is a medical device that received FDA 510(k) clearance on 2026-05-08. It is manufactured by Smylio, Inc.. The 510(k) number is K260788.

When was Smylio Aligners approved by the FDA?

Smylio Aligners received FDA 510(k) clearance on 2026-05-08, under approval number K260788.

What company makes Smylio Aligners?

Smylio Aligners is manufactured by Smylio, Inc..

What is the FDA product code for Smylio Aligners?

The FDA product code for Smylio Aligners is NXC.

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.

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