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Smylio, Inc.
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0
Recent 510(k) Clearances
K-Number
Device
Date
K260788
Smylio Aligners
May 8, 2026
K221537
Nightwear Aligners
April 5, 2023
K212660
Smylio Invisible Clear Aligners
September 22, 2021
K173784
Smylic Invisible Clear Aligners
August 23, 2018