BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BruxZir™ TintEFX Coloring Liquid - G3

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    PRISMATIK DENTALCRAFT, INC.
    Registration Number
    3011649314
    FEI Number
    3011649314
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    ZIP
    92612
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231347

    Owner / Operator

    Firm Name
    PRISMATIK DENTALCRAFT, INC.
    Operator Number
    10043585
    Address
    2144 Michelson Drive
    City
    Irvine
    State
    CA
    Postal Code
    92612
    Country
    US
    Correspondent
    Michelle Gallup

    Products

    Device Name Product Code
    Powder, Porcelain EIH

    Proprietary Names

    BruxZir™ TintEFX Coloring Liquid - G3 BruxZir™ TintEFX Coloring Liquid - Yellow BruxZir™ TintEFX Coloring Liquid - G00 BruxZir™ TintEFX Coloring Liquid - G1 BruxZir™ TintEFX Coloring Liquid - Brown BruxZir™ TintEFX Coloring Liquid - Pink BruxZir™ TintEFX Coloring Liquid - G4 BruxZir™ TintEFX Coloring Liquid - Grey BruxZir™ TintEFX Coloring Liquid - Blue BruxZir™ TintEFX Coloring Liquid - Green BruxZir™ TintEFX Coloring Liquid - G5 BruxZir™ TintEFX Coloring Liquid - Orange BruxZir™ TintEFX Coloring Liquid - G0 BruxZir™ TintEFX Coloring Liquid - Purple

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device