BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Clarity

    Reg #: 2020467 · FEI: 2020467 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    3M UNITEK Corporation
    Registration Number
    2020467
    FEI Number
    2020467
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2724 SOUTH PECK RD.
    City
    MONROVIA
    State
    CA
    ZIP
    91016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K944286

    Owner / Operator

    Firm Name
    3M COMPANY
    Operator Number
    2110898
    Address
    3M Center, 2510 Conway Avenue, Bldg. 275-5W-06
    City
    Saint Paul
    State
    MN
    Postal Code
    55144
    Country
    US
    Correspondent
    JEFFERY J SCHORR

    Products

    Device Name Product Code
    Bracket, Plastic, Orthodontic DYW

    Proprietary Names

    Clarity Unitek Gemini Clear

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198