BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Ti-Max X450 M4

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    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
    K112024

    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

    Ti-Max X450 M4 Ti-Max X450STL Ti-Max X450MWL Ti-Max X450WLED Ti-Max X450KL Ti-Max X450WHL Ti-Max X450 Ti-Max X450 5H Ti-Max X450L

    Establishment Types

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