BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surgic Pro OPT(230V)

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    2
    Classifications
    3

    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
    K173905

    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, Contra- And Right-Angle Attachment, Dental EGS
    Controller, Foot, Handpiece And Cord EBW
    Handpiece, Rotary Bone Cutting KMW

    Proprietary Names

    Surgic Pro OPT(230V) X-SG20L Surgic Pro OPT(120V) Surgic Pro+ OPT(120V) SGL70M SG20 SG70M FC-78 Surgic Pro NON-OPT(120V)

    Establishment Types

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