BEUDAMED
    FDA Registration Active 🇨🇳 China

    Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5

    Reg #: 3031606505 · FEI: 3031606505 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ENPUNO BIOTECHNOLOGY CO., LTD
    Registration Number
    3031606505
    FEI Number
    3031606505
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone
    City
    Changsha Hunan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K250710

    Owner / Operator

    Firm Name
    Enpuno Biotechnology Co., Ltd
    Operator Number
    10090947
    Address
    No. 201,Haiping Park Production Plant 3,No.229, Guyuan Road Changsha High-tech Development Zone
    City
    Changsha
    State
    Hunan
    Postal Code
    410205
    Country
    CN
    Correspondent
    Hao He

    US Agent

    Business Name
    Humiss Inc.
    Contact Name
    James St. Wu
    Address
    1942 Broadway St., STE 314C
    City
    Boulder
    State
    CO
    ZIP
    80302
    Country
    US
    Email
    [email protected]
    Phone
    720 7595888

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    Injectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5

    Establishment Types

    Manufacture Medical Device