Medical Device Manufacturer · US , Fremont , CA

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

4 submissions · 4 cleared · Since 2018

Recent clearances: Smylio Aligners, Nightwear Aligners, Smylio Invisible Clear Aligners

4
Total
4
Cleared
0
Denied

Smylio, Inc. has 4 FDA 510(k) cleared medical devices. Based in Fremont, US.

Latest FDA clearance: May 2026. Active since 2018. Primary specialty: Dental.

Browse the FDA 510(k) cleared devices submitted by Smylio, Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Prime Path Medtech and Jcq Consulting.

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

4 devices
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All4 Dental 4