BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Smartlite Pro Sleeves Refill

    Reg #: 3009142030 · FEI: 3009142030 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    HENRY SCHEIN SERVICES GMBH
    Registration Number
    3009142030
    FEI Number
    3009142030
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Am Heisterbusch 9
    City
    Gallin Mecklenburg-Western Pomerania
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191865

    Owner / Operator

    Firm Name
    HENRY SCHEIN, INC.
    Operator Number
    2411236
    Address
    135 DURYEA RD., --
    City
    Melville
    State
    NY
    Postal Code
    11747
    Country
    US
    Correspondent
    Tracey Alexander

    US Agent

    Business Name
    Henry Schein, Inc.
    Contact Name
    Tracey Alexander
    Address
    135 Duryea Road, E-355
    City
    Melville
    State
    NY
    ZIP
    11747
    Country
    US
    Email
    [email protected]
    Phone
    631 4543003

    Products

    Device Name Product Code
    Activator, Ultraviolet, For Polymerization EBZ
    Caries Detector, Laser Light, Transmission NTK

    Proprietary Names

    Smartlite Pro Sleeves Refill

    Establishment Types

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