K-number	K212660
Device name	Smylio Invisible Clear Aligners
Applicant	Smylio, Inc.
Product code	NXC
Device class	Class II
Decision date	Sep 22, 2021
Decision	Substantially Equivalent
Regulation	872.5470

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Source

View the full FDA submission: accessdata.fda.gov

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Smylio Invisible Clear Aligners

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