BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    IPS e.max Ceram Glaze Spray

    Reg #: 3003310824 · FEI: 3003310824 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    10
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ivoclar Vivadent Manufacturing GmbH
    Registration Number
    3003310824
    FEI Number
    3003310824
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Via Gustav Flora 32
    City
    NATURNO (BZ) Bolzano
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K012174

    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
    Powder, Porcelain EIH

    Proprietary Names

    IPS e.max Ceram Glaze Spray IPS e.max Ceram Selection IPS e.max Ceram IPS Empress Staining IPS e.max Ceram Power IPS e.max CAD Crystall Shades IPS e.max CAD Crystall Stains IPS e.max CAD Crystall Glaze Spray IPS e.max CAD Crystall Glaze Paste IPS e.max Ceram Intro Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)