BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NuSmile BioCem

    Reg #: 3006444232 · FEI: 3006444232 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    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
    K123265

    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
    Liner, Cavity, Calcium Hydroxide EJK
    Cement, Dental EMA

    Proprietary Names

    NuSmile BioCem

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility