FDA 510(k)

Smylio Aligners

K-Number: K260788 · 2026-05-08

Decision Date2026-05-08

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Smylio Aligners is the device name listed in this FDA 510(k) record. The listed applicant is Smylio, Inc.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) 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. The listed applicant is Smylio, Inc.. The 510(k) number is K260788.

When did Smylio Aligners receive FDA 510(k) clearance?

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

Who is the listed applicant for Smylio Aligners?

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

What is the FDA product code for Smylio Aligners?

The FDA product code for Smylio Aligners is NXC.

Other records listing Smylio, Inc. as applicant

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.

K221537Nightwear Aligners K212660Smylio Invisible Clear Aligners K173784Smylic Invisible Clear Aligners

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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.