BEUDAMED
    FDA Registration Active 🇨🇳 China

    Integrated Endo System (Meet Endo-II)

    Reg #: 3008590661 · FEI: 3008590661 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    DENJOY DENTAL CO., LTD
    Registration Number
    3008590661
    FEI Number
    3008590661
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road,
    City
    Changsha city Hunan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K242317

    Owner / Operator

    Firm Name
    DENJOY DENTAL CO., LTD
    Operator Number
    10034843
    Address
    F4, A4 Bld, Lugu Medical Device Park, No. 229 Guyuan Road
    City
    Changsha city
    State
    Hunan
    Postal Code
    410205
    Country
    CN
    Correspondent
    Sheng Zhong

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX
    Scaler, Ultrasonic ELC
    Plugger, Root Canal, Endodontic EKR

    Proprietary Names

    Integrated Endo System (Meet Endo-II)

    Establishment Types

    Manufacture Medical Device