DeviceClearance

Smylio Aligners— 510(k) K260788

Substantially Equivalent

Smylio, Inc.

FDA 510(k) clearance K260788 for Smylio Aligners, Substantially Equivalent on 2026-05-08. Applicant: Smylio, Inc.. Device class: 2.

Summary

Smylio's Smylio Aligners are filed under NXC, sequential aligners.

Class II, 21 CFR 872.5470. Dental is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Smylio filed from Fremont, California. Review took 59 calendar days (March 10 to May 8, 2026).

Clearance details

Applicant
Smylio, Inc.
Product code
Product code NXC
Device class
Class 2
Regulation
21 CFR 872.5470
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Fremont, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NXC

product code NXC
Injury
15,206
Malfunction
2,576
Other
9
Total
17,791

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.