BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Nu Radiance Pit and Fissure Sealant

    Reg #: 3004967419 · FEI: 3004967419 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    NU RADIANCE, INC.
    Registration Number
    3004967419
    FEI Number
    3004967419
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    795 CORONIS WAY
    City
    Ashwaubenon
    State
    WI
    ZIP
    54304
    Country
    US

    Regulatory Submissions

    510(k) Number
    K813091

    Owner / Operator

    Firm Name
    NU RADIANCE, INC.
    Operator Number
    9069582
    Address
    795 CORONIS WAY, --*
    City
    Green Bay
    State
    WI
    Postal Code
    54304
    Country
    US
    Correspondent
    TOM - NOVAK

    Products

    Device Name Product Code
    Sealant, Pit And Fissure, And Conditioner EBC

    Proprietary Names

    Nu Radiance Pit and Fissure Sealant

    Establishment Types

    Repack or Relabel Medical Device