Medical Device Manufacturer · US , Fremont , CA

Smylio, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2018

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Smylio, Inc. Dental ✕

3 devices

1-3 of 3

Cleared Apr 05, 2023

Nightwear Aligners

Cleared Sep 22, 2021

Smylio Invisible Clear Aligners

Cleared Aug 23, 2018

Smylic Invisible Clear Aligners

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 15, 2026