BEUDAMED
    FDA Registration Active 🇨🇳 China

    HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD

    Reg #: 3026312357 · FEI: 3026312357 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    19
    Establishment Types
    1
    Classifications
    7

    Registration Details

    Registration Name
    HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD
    Registration Number
    3026312357
    FEI Number
    3026312357
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan
    City
    Hangzhou Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K250946

    Owner / Operator

    Firm Name
    Hangzhou SHINING3D Dental Technology Co., Ltd
    Operator Number
    10086991
    Address
    9-5-2, Tri-River Valley, Wenyan Street, Xiaoshan
    City
    Hangzhou
    State
    Zhejiang
    Postal Code
    311258
    Country
    CN

    US Agent

    Business Name
    Registrar Corp
    Contact Name
    David Lennarz
    Address
    144 Research Drive
    City
    Hampton
    State
    VA
    ZIP
    23666
    Country
    US
    Email
    [email protected]
    Phone
    757 2240177

    Products

    Device Name Product Code
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Temporary, Resin EBG
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Material, Tooth Shade, Resin EBF
    Material, Impression Tray, Resin EBH
    Positioner, Tooth, Preformed KMY
    Accessories, Implant, Dental, Endosseous NDP

    Proprietary Names

    Denture Base Resin DT20 Dura-Crown LumiCera Tray Resin TR01 Try-in Resin TN11 A1 Try-in Resin TN11 A2 Try-in Resin TN11 A3 Try-in Resin TN11 A3.5 DT01-LT; DT01-LRP ;DT01-OP ;DT01-DK CX100-A1, CX100-A2, CX100-B1, CX100-BL Try-in Resin TN11 B1; Try-in Resin TN11 B2; Try-in Resin TN11 B3; Try-in Resin TN11 BL; DM03; DM12; OD02; W20; DT01-OR; Indirect Bonding Tray Resin IBT Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) Dura-Arch Splint Soft Resin SS01; Splint Hard Resin SH01 Surgical Guide Resin SG01; Surgical Guide Resin SG PRO; Surgical Guide Resin SG02 CB11-B1 CB11-A2 CB11-A1 CB11-A3 CB11-B3 CB11-B2 CB11-A3.5

    Establishment Types

    Manufacture Medical Device