BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Impressa/Sure™

    Reg #: 2126683 · FEI: 2126683 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMERICAN ORTHODONTICS
    Registration Number
    2126683
    FEI Number
    2126683
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3524 Washington Ave
    City
    SHEBOYGAN
    State
    WI
    ZIP
    53081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K963205

    Owner / Operator

    Firm Name
    AMERICAN ORTHODONTICS
    Operator Number
    2126683
    Address
    3524 Washington Avenue, --
    City
    Sheboygan
    State
    WI
    Postal Code
    53081
    Country
    US

    Products

    Device Name Product Code
    Material, Impression ELW

    Proprietary Names

    Impressa/Sure™

    Establishment Types

    Repack or Relabel Medical Device