FDA.reportPublic FDA data

SMYLIO

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30151430073015143007SMYLIO1N2026-01-0148890 Milmont Drive Ste 101D Fremont CA US 94538

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2228841142753015K221537Nightwear AlignersNXC2023-04-05
2228841135608140K212660Smylio Invisible Clear AlignersNXC2021-09-22
2228841438753409K173784Smylic Invisible Clear AlignersNXC2018-08-23
2228841994224853K052090SPLASH! IMPRESSION MATERIAL DEVICEELW2005-08-05
2228841099387744
2228841220065392
2228841811461425

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NXC32023-04-05
ELW12005-08-05

PMN#