BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Avalon Biomed NeoPUTTY

    Reg #: 3006444232 · FEI: 3006444232 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    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
    K181917

    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 NeoPUTTY Avalon Biomed NeoSEALER Flo NuSmile NeoPUTTY Zarc NeoSEALER Flo Bioceramic Root Canal Sealer by Avalon Biomed Avalon Biomed NeoSEALER EZFlo Zarc NeoPUTTY Bioceramic Reparative Cement by Avalon Biomed

    Establishment Types

    Manufacture Medical Device