SMYLIO

FDA Device Registration & Listing · Fremont, CA, US · Registration 3015143007

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015143007
FEI Number
3015143007
Entity Name
SMYLIO
City/State/Country
Fremont, CA, US
Establishment Address
48890 Milmont Drive, Ste 101D, Fremont, CA 94538, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Smylio (Owner Number: 10058597)
Owner / Operator Contact Address
48890 Milmont Drive, Fremont, CA 94538, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

FXTetra Bright Retainers Smylio Retainer 1 FXClear Retainers FXBright Retainers FXClear Aligner Precision Finish Aligner FXBright Aligner Rescue Aligner OrthoFX Tray

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2020-03-16
NXC Aligner, Sequential Dental Class 2 872.5470 2023-10-05
EHY Tray, Impression, Preformed Dental Class 1 872.6880 2020-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Smylio
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015143007. Last updated year: 2026. Please use registration number 3015143007 when referencing this establishment in official correspondence.
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