BEUDAMED
    FDA Registration Active 🇺🇸 United States

    S-Max M500L

    Reg #: 1422375 · FEI: 1000139790 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    92
    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
    K962543

    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

    S-Max M500L M600LG M4 S-Max M500BL PAE-SU B2 PHATELUS 45 TU N-45S MC2-MU M600LG B2 PAE-TU M4 S-Max M500SL N-45T N-75T PANA-MAX SU M4 S-Max M600SL S-Max M600K PAE-M B2 MC-E SU B2/ PAP-SU M4 Ti-Max A700L NL-75M AW300L PANA-MAX TU M4 S-Max M600KL N-75M S-Max M500 AW450L SU ML-XT MU Ti-Max AK600L S-Max M600 Ti-Max A500 S-Max M600WLED AS450L SU PTL-MS Ti-Max A500L PANA-MAX TU B2 S-Max M500KL PA2000 SU M4 PAE-SU M AW455L TU Ti-Max A700 MC2-EMU B2 Ti-Max A600 ML-XT TU AT450 M4 AB450L SU MC-QD TU MLXT-TU S-Max M600WL Ti-Max A600L S-Max pico WHL MC2-SU S-Max M600L Ti-MaxNL-95W T(BRA) Ti-Max AK700L S-Max pico MWL S-Max M600BL PAP-MU B2 PAE-S M4 PAP-MU 5H MC-E TU B2/3 AS455L TU PAE-M M4 PHATELUS 45 SU PANA AIR E M PAP-SU 5H ALPHA AIR HANDPIECE, ULTRA-PUSH, AL PAE-TU B2 MLXT-SU PANA-MAX SU B2 PE-MS S-Max M600BLED MLXT-MU PAE-S B2 S-Max M500K PAP-MU M4 MC-QD SU NL-75T CH45-QD N-75S PAP-SU B2 S-Max M500WL AK400L AT450 B2 PAE-T B2 A450L PAE-T M4 AK450L SU S-Max pico STL PAE-MU B2 M500LG B2 Ti-MaxNL-95W M(BRA) AK455L TU

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198