BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Z800MWL

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NSK AMERICA CORP.
    Registration Number
    1422375
    FEI Number
    1000139790
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1800 Global Parkway
    City
    Hoffman Est
    State
    IL
    ZIP
    60192
    Country
    US

    Regulatory Submissions

    510(k) Number
    K113655

    Owner / Operator

    Firm Name
    NAKANISHI INC.
    Operator Number
    8030216
    Address
    1800 Global Pkwy
    City
    Hoffman Est
    State
    IL
    Postal Code
    60192
    Country
    US
    Correspondent
    Satoru Ikeda

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB

    Proprietary Names

    Z800MWL Ti-Max X700 Ti-Max X Turbine Z900KL Ti-Max X600WLED Ti-Max X600L Z800L Ti-Max X500WLED Ti-Max X500L Ti-Max X600WHL Z800STL Z800WHL Ti-Max X500SL Z900L Z800WL Ti-Max X700KL Z900WHL Z900MWL NL9000 Ti-Max X700L Ti-Max X500KL Z800KL Ti-Max Z Turbine Z900WL Ti-Max X600 Ti-Max X600BLED Z900STL Ti-Max X600SL Ti-Max X700SL Ti-Max X600KL

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device