BEUDAMED
    FDA Registration Active 🇨🇳 China

    Dental Electrical Motor iRoot Pro

    Reg #: 3017618678 · FEI: 3017618678 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD
    Registration Number
    3017618678
    FEI Number
    3017618678
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NO.9 Changyang road, West Taihu Science Techology Industrial Park
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191276

    Owner / Operator

    Firm Name
    ChangZhou BoMedent Medical Technology Co., Ltd
    Operator Number
    10078266
    Address
    NO.9 Changyang road, West Taihu Science Techology Industrial Park
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213100
    Country
    CN

    US Agent

    Business Name
    MEDRIGHT TECH INC
    Contact Name
    Jessie Yao
    Address
    6302 FORT HAMILTON PARKWAY, 1R
    City
    Brooklyn
    State
    NY
    ZIP
    11219
    Country
    US
    Email
    [email protected]
    Phone
    718 2169957

    Products

    Device Name Product Code
    Handpiece, Direct Drive, Ac-Powered EKX
    Locator, Root Apex LQY

    Proprietary Names

    Dental Electrical Motor iRoot Pro

    Establishment Types

    Manufacture Medical Device