BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avalon Biomed NeoMTA 2

    Reg #: 3006444232 · FEI: 3006444232 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NUSMILE, LTD
    Registration Number
    3006444232
    FEI Number
    3006444232
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    3315 W 12th St
    City
    HOUSTON
    State
    TX
    ZIP
    77008
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161239

    Owner / Operator

    Firm Name
    NUSMILE, LTD
    Operator Number
    9106343
    Address
    3315 W. 12th, --
    City
    Houston
    State
    TX
    Postal Code
    77008
    Country
    US
    Correspondent
    DIANE JOHNSON KRUEGER

    Products

    Device Name Product Code
    Resin, Root Canal Filling KIF

    Proprietary Names

    Avalon Biomed NeoMTA 2 NuSmile NeoMTA 2 NuSmile NeoMTA ES MTA 2.3.1 Zarc NeoMTA 2 Bioceramic Reparative Cement by Avalon Biomed

    Establishment Types

    Manufacture Medical Device