BEUDAMED
    FDA Registration Active 🇺🇸 United States

    341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml

    Reg #: 2086043 · FEI: 3000719964 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PAC-DENT INC.
    Registration Number
    2086043
    FEI Number
    3000719964
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    670 Endeavor Circle
    City
    Brea
    State
    CA
    ZIP
    92821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231060

    Owner / Operator

    Firm Name
    Pac-Dent Inc.
    Operator Number
    10056434
    Address
    670 Endeavor Cir
    City
    Brea
    State
    CA
    Postal Code
    92821
    Country
    US
    Correspondent
    Tom Peng

    Products

    Device Name Product Code
    Varnish, Cavity LBH
    Agent, Polishing, Abrasive, Oral Cavity EJR

    Proprietary Names

    341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml 341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case Promin Dental Desensitizing Gel 341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case

    Establishment Types

    Manufacture Medical Device