BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SMYLIO

    Reg #: 3015143007 · FEI: 3015143007 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    5

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    Registration Details

    Registration Name
    SMYLIO
    Registration Number
    3015143007
    FEI Number
    3015143007
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    48890 Milmont Drive, Ste 101D
    City
    Fremont
    State
    CA
    ZIP
    94538
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212660

    Owner / Operator

    Firm Name
    Smylio
    Operator Number
    10058597
    Address
    48890 Milmont Drive
    City
    Fremont
    State
    CA
    Postal Code
    94538
    Country
    US

    Products

    Device Name Product Code
    Maintainer, Space Preformed, Orthodontic DYT
    Aligner, Sequential NXC
    Tray, Impression, Preformed EHY
    Wax, Dental, Intraoral EGD
    Material, Impression ELW

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device