BEUDAMED
    FDA Registration Active 🇨🇳 China

    NiTi K Files/H Files/Reamers; Files holder; C+ Files, U Files; Microscope Files;

    Reg #: 3011554142 · FEI: 3011554142 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN DENCO MEDICAL CO., LTD.
    Registration Number
    3011554142
    FEI Number
    3011554142
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rm 3108, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist,
    City
    Shenzhen Guangdong
    Country
    CN

    Owner / Operator

    Firm Name
    SHENZHEN DENCO MEDICAL CO., LTD.
    Operator Number
    10048487
    Address
    Rm 3108, Bldg 6, Tian'an Cloud Park, Bantian Str, Longgang Dist,
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518129
    Country
    CN
    Correspondent
    Yongjun Xia

    US Agent

    Business Name
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln.,
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    File, Pulp Canal, Endodontic EKS

    Proprietary Names

    NiTi K Files/H Files/Reamers; Files holder; C+ Files, U Files; Microscope Files; NiTi Hand Use Files; Paste Carriers; Stainless Steel K Files/H Files/Reamers; PRE-SHAPER; SUPER FILES; PRO-PATH; D-FILES; PRIMARY FILES (KIDS FILES); PA-FILES; SUPER FILES II) NiTi Rotary Files (SUPER FILES III; D-SUPER FILES; D-SHAPER; PRO-FLEXI FILES; ONLY ONE FILE; W FILES; ROLL WAVE; C Plus files; PD files; Microscope File Holder; Smart files holder

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device