Smylio, Inc.

FDA Regulatory Profile

Smylio, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on May 8, 2026.

Summary

Total Recalls
0
510(k) Clearances
4
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K260788Smylio AlignersMay 8, 2026
K221537Nightwear AlignersApril 5, 2023
K212660Smylio Invisible Clear AlignersSeptember 22, 2021
K173784Smylic Invisible Clear AlignersAugust 23, 2018