BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Obsidian Press 3-Pack C126 C1

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    131
    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
    K100781

    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

    Obsidian Press 3-Pack C126 C1 Obsidian Press GD 5-Pack C123 D2 Obsidian Milling Block 5-Pack D2 Obsidian Press 3-Pack C126 A2 Obsidian Milling Block GD 5-Pack W14 No Mandrel B2 Obsidian Milling Block GD 5-Pack A3.5 Obsidian Milling Blocks Variety Pack Obsidian Press GD 5-Pack C123 B3 Obsidian Milling Block GD 5-Pack C2 Obsidian Milling Block 5-Pack W14 C-Mandrel B1 Obsidian Press GD 3-Pack C126 BL1 Obsidian Press 3-Pack C158 D3 Obsidian Milling Block GD 5-Pack BL1 Obsidian Press GD 3-Pack C158 BL1 Obsidian Press 5-Pack C123 A3.5 Obsidian Milling Block 5-Pack BL1 Obsidian Press 3-Pack C126 A3 Obsidian Milling Block GD 5-Pack A1 Obsidian Milling Block GD 5-Pack A2 Obsidian Milling Block 5-Pack W14 C-Mandrel C2 Obsidian Milling Block GD 5-Pack W14 No Mandrel D3 Obsidian Press GD 3-Pack C126 B2 Obsidian Press 3-Pack C158 A3.5 Obsidian Press GD 5-Pack C123 D3 Obsidian Press GD 3-Pack C126 A1 Obsidian Press GD 3-Pack C158 A3 Obsidian Milling Block GD 5-Pack C1 Obsidian Press GD 5-Pack C123 C1 Obsidian Press 5-Pack C123 C1 Obsidian Milling Block GD 5-Pack W14 No Mandrel A1 Obsidian Press GD 3-Pack C126 BL4 Obsidian Press 3-Pack C126 BL1 Obsidian Press 5-Pack C123 C3 Obsidian Press GD 3-Pack C158 C2 Obsidian Milling Block GD 5-Pack W14 No Mandrel B3 Obsidian Press GD 3-Pack C158 B1 Obsidian Milling Block GD 5-Pack W14 No Mandrel A3 Obsidian Milling Block 5-Pack W14 C-Mandrel BL4 Obsidian Press GD 3-Pack C158 C1 Obsidian Milling Block 5-Pack C2 Obsidian Press 5-Pack C123 A3 Obsidian Press 3-Pack C158 B2 Obsidian Milling Block GD 5-Pack BL4 Obsidian Press GD 5-Pack C123 BL1 Obsidian Milling Block 5-Pack B3 Obsidian Milling Block 5-Pack W14 C-Mandrel B3 Obsidian Press GD 5-Pack C123 A1 Obsidian Milling Block 5-Pack B1 Obsidian Press 3-Pack C158 BL1 Obsidian Press GD 3-Pack C126 C1 Obsidian Milling Block 5-Pack BL4 Obsidian Press 5-Pack C123 A1 Obsidian Press 3-Pack C126 A1 Obsidian Press GD 5-Pack C123 B2 Obsidian Press GD 3-Pack C158 A1 Obsidian Milling Block GD 5-Pack W14 No Mandrel C3 Obsidian Milling Block 5-Pack C1 Obsidian Milling Block 5-Pack W14 C-Mandrel A1 Obsidian Press GD 3-Pack C126 B1 Obsidian Milling Block GD 5-Pack B2 Obsidian Milling Block GD 5-Pack B3 Obsidian Milling Block 5-Pack B2 Obsidian Milling Block GD 5-Pack W14 No Mandrel C2 Obsidian Press GD 5-Pack C123 B1 Obsidian Press GD 5-Pack C123 C2 Obsidian Press 3-Pack C126 A3.5 Obsidian Milling Block 5-Pack W14 C-Mandrel D2 Obsidian Press GD 3-Pack C126 C3 Obsidian Press GD 3-Pack C158 BL4 Obsidian Press 3-Pack C126 B3 Obsidian Press GD 5-Pack C123 A3.5 Obsidian Milling Block 5-Pack A3 Obsidian Press GD 3-Pack C126 D2 Obsidian Milling Block GD 5-Pack C3 Obsidian Press GD 3-Pack C158 D3 Obsidian Press 3-Pack C158 B3 Obsidian Milling Block A2 (Single Pack) Cerec Sample Obsidian Milling Block 5-Pack W14 C-Mandrel B2 Obsidian Milling Block 5-Pack W14 C-Mandrel BL1 Obsidian Press 5-Pack C123 BL4 Obsidian Press GD 3-Pack C158 A2 Obsidian Milling Block GD 5-Pack W14 No Mandrel A3.5 Obsidian Press 3-Pack C158 A1 Obsidian Press GD 5-Pack C123 A2 Obsidian Press GD 3-Pack C158 C3 Obsidian Milling Block 5-Pack D3 Obsidian Press GD 5-Pack C123 C3 Obsidian Press GD 3-Pack C158 A3.5 Obsidian Milling Block 5-Pack A1 Obsidian Press 3-Pack C158 A2 Obsidian Milling Block GD 5-Pack W14 No Mandrel B1 Obsidian Press 3-Pack C158 A3 Obsidian Press GD 3-Pack C126 B3 Obsidian Milling Block GD 5-Pack D3 Obsidian Milling Blocks Trial Kit Obsidian Press GD 3-Pack C158 B3 Obsidian Press GD 5-Pack C123 A3 Obsidian Press 3-Pack C158 B1 Obsidian Milling Block GD 5-Pack W14 No Mandrel BL4 Obsidian Press GD 3-Pack C126 C2 Obsidian Milling Block GD 5-Pack W14 No Mandrel D2 Obsidian Press GD 3-Pack C158 D2 Obsidian Press 5-Pack C123 D2 Obsidian Press 3-Pack C158 C2 Obsidian Press GD 5-Pack C123 BL4 Obsidian Press 5-Pack C123 D3 Obsidian Milling Block GD 5-Pack W14 No Mandrel BL1 Obsidian Press 5-Pack C123 C2 Obsidian Milling Block GD 5-Pack A3 Obsidian Milling Block 5-Pack C3 Obsidian Milling Block 5-Pack W14 C-Mandrel A2 Obsidian Milling Block GD 5-Pack W14 No Mandrel A2 Obsidian Milling Block 5-Pack W14 C-Mandrel A3.5 Obsidian Milling Block GD 5-Pack D2 Obsidian Milling Block 5-Pack W14 C-Mandrel A3 Obsidian Press 5-Pack C123 A2 Obsidian Press GD 3-Pack C126 A3.5 Obsidian Press GD 3-Pack C126 A2 Obsidian Press GD 3-Pack C158 B2 Obsidian Milling Block 5-Pack A3.5 Obsidian Press 3-Pack C158 BL4 Obsidian Press GD 3-Pack C126 D3 Obsidian Press GD 3-Pack C126 A3 Obsidian 1 A2 Single Sample on C-Mandrel in Tooth Box Obsidian Press 3-Pack C158 D2 Obsidian Press 3-Pack C158 C3 Obsidian Milling Block GD 5-Pack W14 No Mandrel C1 Obsidian Milling Block GD 5-Pack B1 Obsidian Press 5-Pack C123 BL1 Obsidian Milling Block 5-Pack A2 Obsidian Press 3-Pack C158 C1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device