BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ClassOne Safety Release Modules

    Reg #: 2081322 · FEI: 2081322 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO ORGANIZERS, INC.
    Registration Number
    2081322
    FEI Number
    2081322
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1822 ASTON AVE
    City
    CARLSBAD
    State
    CA
    ZIP
    92008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K961754

    Owner / Operator

    Firm Name
    ORTHO ORGANIZERS , INC.
    Operator Number
    2081322
    Address
    1822 Aston Avenue, --
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Nicole - Rajek

    Products

    Device Name Product Code
    Headgear, Extraoral, Orthodontic DZB

    Proprietary Names

    ClassOne Safety Release Modules Masel Safety Release Modules Multi-Adjustable Facemask

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device