BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BruxZir Block, GD 20mm Z - 5/pk

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    88
    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
    K060104

    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 Block, GD 20mm Z - 5/pk BruxZir Block, GD 20mm OSZ, 5 pk BruxZir Block, GD 25mm Standard - 1/pk Bruxzir Liquid, D2 BruxZir Block, GD 25mm OSZ, 1pk BruxZir Block, GD 25mm OSZ, 4 pk Bruxzir Liquid Bulk, C1 Bruxzir Liquid, D3 BruxZir Block, GD 22mm ZZ Bruxzir Liquid Bulk, B3 Bruxzir Liquid Bulk, D3 Bruxzir Liquid, B4 Bruxzir Liquid Bulk, D4 BruxZir Block, GD 15mm Z - 5/pk BruxZir Block, GD 12mm Z - 1/pk BruxZir Block, GD 10mm ZZ BruxZir Block, GD 15mm R - 5/pk BruxZir Block, GD 15mm D - 1/pk Bruxzir Liquid, B2 Bruxzir Liquid Bulk, A3.5 BruxZir Block, GD 15mm L BruxZir Block, GD 20mm D - 5/pk Bruxzir Liquid Bulk, A1 BruxZir Block, GD 12mm Z - 5/pk BruxZir Block, GD 10mm ZZ - Notch - 5/pk BruxZir Block, GD 10mm ZZ - Notch BruxZir Block, GD 25mm R BruxZir Block, GD 25mm D - 4/pk BruxZir Block, GD 15mm Standard - 1/pk Bruxzir Liquid, C4 BruxZir Block, GD 15mm R - 1/pk BruxZir Block, GD 14mm ZZ - Notch Bruxzir Liquid Bulk, B2 BruxZir Block, GD 20mm R - 1/pk BruxZir Block, GD 12mm Standard - 5/pk BruxZir Block, GD 20mm R - 5/pk Bruxzir Liquid Bulk, B1 BruxZir Block, GD 14mm Nash Sales - 5/pk Bruxzir Liquid, A1 BruxZir Block, GD 20mm D - 1/pk BruxZir Block, GD 18mm ZZ Bruxzir Liquid, D4 BruxZir Block, GD 15mm Z - 1/pk BruxZir Block, GD 30mm Standard -1/pk Bruxzir Liquid, B1 Bruxzir Liquid, A3.5 BruxZir Block, GD 20mm OSZ, 1pk BruxZir Block, GD 22mm ZZ - Notch 5 pk BruxZir Block, GD 30mm Standard - 1/pk Bruxzir Liquid, C1 Bruxzir Liquid Bulk, D2 Bruxzir Liquid, A4 BruxZir Block, GD 12mm D - 1/pk BruxZir Block, GD 25mm Z - 1/pk Bruxzir Liquid, A3 BruxZir Block, GD 20mm Z - 1/pk Bruxzir Liquid, A2 BruxZir Block, GD 12mm D - 5/pk Bruxzir Liquid Bulk, A2 Bruxzir Liquid Bulk, C2 BruxZir Block, GD 18mm ZZ - Notch - 5/pk BruxZir Coloring Liquids Kit BruxZir Block, GD 25mm Z - 4/pk BruxZir Block, GD 12mm R - 5/pk Bruxzir Liquid Bulk, B4 BruxZir Block, GD 14mm ZZ Bruxzir Liquid, C2 BruxZir Block, GD 25mm R - 4/pk BruxZir Block, GD 18mm ZZ - Notch BruxZir Block, GD 14mm ZZ - Notch - 5/pk Bruxzir Liquid Bulk, C3 Bruxzir Liquid Bulk, A4 BruxZir Block, GD 30mm Standard - 4/pk BruxZir Block, GD 15mm Standard - 5/pk BruxZir Block, GD 20mm Standard - 1/pk BruxZir Block, GD 12mm R - 1/pk Bruxzir Liquid Bulk, C4 BruxZir Block, GD 30mm Z - 1/PK BruxZir Block, GD 25mm D - 1/pk BruxZir Block, GD 20mm Standard - 5/pk BruxZir Block, GD 30mm D - 4/pk Bruxzir Liquid, C3 BruxZir Block, GD 15mm D - 5/pk Bruxzir Liquid, B3 Bruxzir Liquid Bulk, A3 BruxZir Block, GD 30mm Z - 4/PK BruxZir Block, GD 25mm Standard - 4/pk BruxZir Block, GD 22mm ZZ - Notch 1 pk

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device