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    FDA Registration Active 🇺🇸 United States

    BruxZir® Radiant - White 16mm - GD

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    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
    K240574

    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® Radiant - White 16mm - GD BruxZir® Radiant - 300 16mm - GD BruxZir® Radiant - 300 14mm - GD BruxZir® Radiant - 200 20mm - GD BruxZir® Radiant - 400 16mm - GD BruxZir® Radiant - 400 14mm - GD BruxZir® Radiant - White 22mm - GD BruxZir® Radiant - 200 16mm - GD BruxZir® Radiant - White 20mm - GD BruxZir® Radiant - Brite 16mm - GD BruxZir® Radiant - 200 14mm - GD BruxZir® Radiant - 400 20mm - GD BruxZir® Radiant - 400 22mm - GD BruxZir® Radiant - 300 20mm - GD BruxZir® Radiant - Brite 14mm - GD BruxZir® Radiant - 100 20mm - GD BruxZir® Radiant - 200 22mm - GD BruxZir® Radiant - Brite 22mm - GD BruxZir® Radiant - 100 22mm - GD BruxZir® Radiant - 100 16mm - GD BruxZir® Radiant - 100 14mm - GD BruxZir® Radiant - White 14mm - GD BruxZir® Radiant - Brite 20mm - GD BruxZir® Radiant - 300 22mm - GD

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198