BEUDAMED
    FDA Registration Active 🇨🇳 China

    LuxCreo Dental Night Guard Resin

    Reg #: 3021024355 · FEI: 3021024355 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NINGBO SEZEN TECHNOLOGY CO., LTD.
    Registration Number
    3021024355
    FEI Number
    3021024355
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2F, 13th Building, 518 Xinmei Road, Yinzhou District,
    City
    Ningbo Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K230592

    Owner / Operator

    Firm Name
    Ningbo Sezen Technology Co., Ltd.
    Operator Number
    10087624
    Address
    2F, 13th Building, 518 Xinmei Road, Yinzhou District,
    City
    Ningbo
    State
    Zhejiang
    Postal Code
    315000
    Country
    CN
    Correspondent
    Hanyu Xiang

    US Agent

    Business Name
    LuxCreo Inc.
    Contact Name
    Mike Yang
    Address
    350 W. Ontario Street Suite 700 Chicago,lL.60654
    City
    Chicago
    State
    IL
    ZIP
    60654
    Country
    US
    Email
    [email protected]
    Phone
    650 3360888

    Products

    Device Name Product Code
    Positioner, Tooth, Preformed KMY
    Mouthguard, Prescription MQC

    Proprietary Names

    LuxCreo Dental Night Guard Resin

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)