BEUDAMED
    FDA Registration Active 🇨🇳 China

    Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML

    Reg #: 3009643402 · FEI: 3009643402 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BLOOMDEN BIOCERAMICS (HUNAN) CO.,LTD.
    Registration Number
    3009643402
    FEI Number
    3009643402
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone
    City
    Changsha Hunan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K212765

    Owner / Operator

    Firm Name
    Bloomden Bioceramics (HuNan) Co.,Ltd.
    Operator Number
    10083450
    Address
    No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley, Linyu Rd, Dongfanghong Street, Hi-tech Development Zone
    City
    Changsha
    State
    Hunan
    Postal Code
    410000
    Country
    CN
    Correspondent
    Shengyong Liao

    US Agent

    Business Name
    Shenzhen Joyantech Consulting Co., Ltd.
    Contact Name
    Thomas Tang
    Address
    25 Hopewell Drive Stony Brook, NY 11790, USA
    City
    Stony Brook
    State
    NY
    ZIP
    11790
    Country
    US
    Email
    [email protected]
    Phone
    631 7511103

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-C

    Establishment Types

    Manufacture Medical Device