BEUDAMED
    FDA Registration Active 🇦🇹 Austria

    Bluephase M8

    Reg #: 1000493628 · FEI: 1000493628 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    IVOCLAR VIVADENT Manufacturing GmbH
    Registration Number
    1000493628
    FEI Number
    1000493628
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    BREMSCHLSTRASSE 16
    City
    BURS Vorarlberg
    Country
    AT

    Regulatory Submissions

    510(k) Number
    K110756

    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
    Activator, Ultraviolet, For Polymerization EBZ

    Proprietary Names

    Bluephase M8 Bluephase G4 bluephase Style Bluephase G4 100 Bluephase EasyCure

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)