US device clearances
4 510(k) clearances and PMA approvals since 2015
- Smylio Aligners K260788 · 8 May 2026
- Nightwear Aligners K221537 · 5 Apr 2023
- Smylio Invisible Clear Aligners K212660 · 22 Sep 2021
- Smylic Invisible Clear Aligners K173784 · 23 Aug 2018
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.