BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Six Month Smiles

    Reg #: 3008882689 · FEI: 3008882689 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Xplora USA LLC
    Registration Number
    3008882689
    FEI Number
    3008882689
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1501 Randolph St, Ste K16
    City
    Carrollton
    State
    TX
    ZIP
    75006
    Country
    US

    Regulatory Submissions

    510(k) Number
    K131734

    Owner / Operator

    Firm Name
    Xplora USA LLC
    Operator Number
    10089697
    Address
    1501 Randolph St, Ste K16
    City
    Carrollton
    State
    TX
    Postal Code
    75006
    Country
    US
    Correspondent
    Bruce Page

    Products

    Device Name Product Code
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    Six Month Smiles

    Establishment Types

    Repack or Relabel Medical Device