BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    Universal Overglaze-High Flu

    Reg #: 3011824442 · FEI: 3011824442 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DENTSPLY IH BV
    Registration Number
    3011824442
    FEI Number
    3011824442
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Piri Reisweg 23
    City
    Sevenum Limburg
    Country
    NL

    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

    US Agent

    Business Name
    DENTSPLY SIRONA INC
    Contact Name
    Dan Eagar
    Address
    13320 Ballantyne Corp Pl
    City
    Charlotte
    State
    NC
    ZIP
    28277
    Country
    US
    Email
    [email protected]
    Phone
    704 4926977

    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

    Export Device to the United States But Perform No Other Operation on Device