BEUDAMED
    FDA Registration Active 🇺🇸 United States

    X-SG65L

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    1
    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
    K970953

    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, Rotary Bone Cutting KMW

    Proprietary Names

    X-SG65L SG256TL55 STR SGT2-E X-SG65 SGR-E SGO-1 X-DSG20 Ti-SG65L SGO-5 SGO-4 Ti-SG25L SGO-E SGM-ER32i SGO2-E E-TYPE SPEED REDUCER CONTRA ANGLE SGP-E20RI SGO-6 SGP-E64RI SGM-E20RI SGMS-ER20i SGQ-ER20h SGP-E32RI SGM-E10RI SGM-E256RI SGR2-E SGM-ER256i SGM-E16RI SGM-ER16i SGP-E16RI SGM-ER20i Ti-SG20L X-DSG20h SGO-2 SGM-ER64i SGP-E256RI SGP-E10RI Ti-SG20 X-DSG20Lh SGO-3 X-DSG20L SGT-E

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198