BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Universal Overglaze-High Flu

    Reg #: 2647456 · FEI: 2647456 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DS REP B.V.
    Registration Number
    2647456
    FEI Number
    2647456
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    State Road 183, KM 20.1
    City
    Las Piedras
    State
    PR
    ZIP
    00771
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161269

    Owner / Operator

    Firm Name
    DENTSPLY SIRONA INC
    Operator Number
    2511302
    Address
    221 WEST PHILADELPHIA ST., SUITE 60W
    City
    York
    State
    PA
    Postal Code
    17401
    Country
    US

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    Universal Overglaze-High Flu Universal Stain CELTRA Duo Universal Incisal Stain Dentsply Sirona Universal Stain Celtra Ceram Dentsply Sirona Universal Stain & Overglaze Kit Universal Body Stain Dentsply Sirona Universal Body Stain Dentsply Sirona Universal Incisal Stain Dentsply Sirona Universal Overglaze Universal Overglaze Dentsply Sirona Universal Overglaze-High Flu

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)