BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IPS Empress 2

    Reg #: 2244842 · FEI: 2244842 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ivoclar Vivadent Manufacturing, Inc
    Registration Number
    2244842
    FEI Number
    2244842
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    500 MEMORIAL DR.
    City
    Somerset
    State
    NJ
    ZIP
    08873
    Country
    US

    Regulatory Submissions

    510(k) Number
    K982616

    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

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    IPS Empress 2 IPS e.max Press LT IPS e.max Press IPS e.max CAD Cryst Glaze Paste Fluo IPS e.max Press HT IPS e.max Press HO

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)