BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CAD/CAM PlanMill Starter Kit

    Reg #: 2244842 · FEI: 2244842 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    16
    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
    K051705

    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

    CAD/CAM PlanMill Starter Kit IPS e.max CAD for Planmill IPS e.max CAD MT IPS e.max CAD for InLab IPS e.max CAD LT IPS e.max ZirCAD for Inlab IPS e.max CAD HT IPS e.max CAD Impulse CAD/CAM Chairside for CEREC Starter Kit CAD/CAM CS for PlanMill Starter Kit CAD/CAM CS for CEREC Starter Kit IPS e.max CAD CEREC IPS e.max ZirCAD for PlanMill IPS e.max CAD IPS e.max ZirCAD CAD/CAM CEREC Starter Kit

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)