BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Phase Ortho Clear Aligner

    Reg #: 3017929907 · FEI: 3017929907 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PHASE ORTHO
    Registration Number
    3017929907
    FEI Number
    3017929907
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3332 Gilmore Industrial Blvd
    City
    Louisville
    State
    KY
    ZIP
    40213
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173785

    Owner / Operator

    Firm Name
    Phase Ortho
    Operator Number
    10080066
    Address
    3332 Gilmore industrial blvd
    City
    Louisville
    State
    KY
    Postal Code
    40213
    Country
    US
    Correspondent
    Breanne Butler

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    Phase Ortho Clear Aligner Smile Shapers Clear Aligner Tru-Smile Clear Aligner

    Establishment Types

    Repack or Relabel Medical Device