BEUDAMED
    FDA Registration Active 🇱🇮 Liechtenstein

    IPS Empress Direct Effect

    Reg #: 9612352 · FEI: 3002808636 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    IVOCLAR VIVADENT AG
    Registration Number
    9612352
    FEI Number
    3002808636
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BENDERERSTRASSE 2
    City
    SCHAAN
    Country
    LI

    Regulatory Submissions

    510(k) Number
    K103528

    Owner / Operator

    Firm Name
    IVOCLAR VIVADENT
    Operator Number
    8010208
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    Postal Code
    14228
    Country
    US
    Correspondent
    Dana Glina

    US Agent

    Business Name
    Ivoclar Vivadent
    Contact Name
    Anderjeet Gulati
    Address
    175 Pineview Dr.
    City
    Amherst
    State
    NY
    ZIP
    14228
    Country
    US
    Email
    [email protected]
    Phone
    716 2642046

    Products

    Device Name Product Code
    Sealant, Pit And Fissure, And Conditioner EBC
    Coating, Filling Material, Resin EBD
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    IPS Empress Direct Effect

    Establishment Types

    Manufacture Medical Device