BEUDAMED
    FDA Registration Active 🇨🇳 China

    SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD.

    Reg #: 3015342395 · FEI: 3015342395 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    SHANGHAI SMARTEE DENTI-TECHNOLOGY CO., LTD.
    Registration Number
    3015342395
    FEI Number
    3015342395
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K223454

    Owner / Operator

    Firm Name
    Shanghai Smartee Denti-Technology Co., Ltd.
    Operator Number
    10060314
    Address
    2nd Floor, No.27& Room 201, 203, 204, 205, No.32 and No.34, Lane 565, Shengxia Road, China (Shanghai) pilot free trade zone
    City
    Shanghai
    State
    CN-NOTA
    Postal Code
    201210
    Country
    CN
    Correspondent
    Junfeng Yao

    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
    Positioner, Tooth, Preformed KMY
    Aligner, Sequential NXC
    Band, Material, Orthodontic DYO
    Indirect Bonding Tray QJJ
    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations NOF

    Proprietary Names

    POSITIONER, TOOTH, PREFORMED, Clear Retainer (YCL-A-R, YCL-C-R), REF04 ClearCorrect System Retainer Custom-made Invisible Aligners Dental Sheet REF06 ClearCorrect System Engager Template Byte Aligner System REF03 ClearCorrect System Aligners(Multi-layer) AS 260a; Intraoral Scanners, AS 100, AS 200E, NeoScan 1000, AS 260, NeoScan 2000, K EYE, K EYE blue X, i ScanPro; Owandy ios; Owandy ios Wireless; ST 200E

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device