Smylio Invisible Clear Aligners

Aligner, Sequential

Smylio, Inc

The following data is part of a premarket notification filed by Smylio, Inc with the FDA for Smylio Invisible Clear Aligners.

Pre-market Notification Details

Device IDK212660
510k NumberK212660
Device Name:Smylio Invisible Clear Aligners
ClassificationAligner, Sequential
Applicant Smylio, Inc 48890 Milmont Dr. Fremont,  CA  94538
ContactRen Menon
CorrespondentBreanne Butler
Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston,  TX  77043
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2021-09-22

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