BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    HyGenie

    Reg #: 9614686 · FEI: 3003340029 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
    Registration Number
    9614686
    FEI Number
    3003340029
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    59-2 MINAMI-CHO
    City
    ITABASHI-KU Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K073652

    Owner / Operator

    Firm Name
    NAKAMURA DENTAL HANDPIECE MFG. CO., LTD.
    Operator Number
    9010791
    Address
    59-2 MINAMI-CHO, ITABASHI-KU
    City
    TOKYO
    State
    JP-13
    Postal Code
    173-0027
    Country
    JP
    Correspondent
    SHINICHI - NAKAMURA

    US Agent

    Business Name
    HEAD DENTAL CORPORATION
    Contact Name
    Shinichi Ito
    Address
    17972 Sky Park Circle, Suite J
    City
    Irvine
    State
    CA
    ZIP
    92614
    Country
    US
    Email
    [email protected]
    Phone
    949 4740176

    Products

    Device Name Product Code
    Handpiece, Air-Powered, Dental EFB
    Handpiece, Contra- And Right-Angle Attachment, Dental EGS

    Proprietary Names

    HyGenie ProphyPro Prophy Sport Quality Plus ACCLEAN Xpro ND

    Establishment Types

    Manufacture Medical Device