BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OrthoFlex Composite Eyelet

    Reg #: 1056191 · FEI: 1000132261 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ORTHO TECHNOLOGY, Inc
    Registration Number
    1056191
    FEI Number
    1000132261
    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
    K973776

    Owner / Operator

    Firm Name
    ORTHO TECHNOLOGY, Inc
    Operator Number
    9008664
    Address
    1822 Aston Ave
    City
    Carlsbad
    State
    CA
    Postal Code
    92008
    Country
    US
    Correspondent
    Nicole - Rajek

    Products

    Device Name Product Code
    Bracket, Plastic, Orthodontic DYW

    Proprietary Names

    OrthoFlex Composite Eyelet OrthoFlex Composite Buttons Orthoflex Composite Brackets Bite-Builder

    Establishment Types

    Repack or Relabel Medical Device