BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EX-203C B2

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    20
    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
    K962542

    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

    EX-203C B2 FX204 M4 EX-203 B2 PTL-950 EX-203C M4 EX-103 M4 IS-205 B2/3 IS-205 M4 FX205 M4 EX-203 M4 PTL-SDN(W/O FIBER) PTL-CD PTL-CR iProphy Air PTL-950Ti Ti205L FX205 B2 EX-204 M4 EX-117 AIR MOTOR HANDPIECE TN-102

    Establishment Types

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