BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Obsidian Milling Block GD 5-Pack W14 No Mandrel D3

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    64
    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
    K141788

    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 Milling Block GD 5-Pack W14 No Mandrel D3 Obsidian Milling Block 5-Pack W14 TS150 A1 Obsidian Milling Block 5-Pack W14 TS150 D3 Obsidian Milling Blocks Variety Pack Obsidian Paste Stain Violet, 3g Obsidian Milling Block 5-Pack W14 TS150 D2 Obsidian Milling Block A2 (Single Pack) Cerec Sample Obsidian Milling Block GD 5-Pack W14 No Mandrel C2 Obsidian Milling Block GD 5-Pack W14 TS150 C3 Obsidian Milling Block 5-Pack W14 TS150 A2 Obsidian Paste Stain C, 3g Obsidian Paste Stain Yellow, 3g Obsidian Milling Block 5-Pack W14 TS150 C3 Obsidian Milling Block 5-Pack W14 TS150 C2 Obsidian Milling Block GD 5-Pack W14 TS150 A3.5 Obsidian Paste Stain Black, 3g Obsidian Paste Stain White, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel A3 Obsidian Paste Stain D, 3g Obsidian Milling Block 5-Pack W14 TS150 A3.5 Obsidian Milling Block GD 5-Pack W14 No Mandrel B3 Obsidian Paste Stain Pink, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel BL1 Obsidian Milling Block 5-Pack W14 TS150 B3 Obsidian Milling Block GD 5-Pack W14 No Mandrel A3.5 Obsidian Milling Block GD 5-Pack W14 TS150 C1 Obsidian Milling Block 5-Pack W14 TS150 B1 Obsidian Milling Block 5-Pack W14 TS150 B2 Obsidian Glaze Liquid, 15ml Obsidian Milling Blocks Trial Kit Obsidian Paste Stain Blue, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel D2 Obsidian 1 A2 Single Sample on C-Mandrel in Tooth Box Obsidian Milling Block GD 5-Pack W14 TS150 A1 Obsidian Paste Stain Green, 3g Obsidian Paste Stain Ocher, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel B2 Obsidian Milling Block GD 5-Pack W14 No Mandrel A1 Obsidian Milling Block GD 5-Pack W14 TS150 B1 Obsidian Paste Stain Brown, 3g Obsidian Milling Block 5-Pack W14 TS150 BL4 Obsidian Milling Block GD 5-Pack W14 TS150 A3 Obsidian Milling Block GD 5-Pack W14 TS150 C2 Obsidian Milling Block 5-Pack W14 TS150 C1 Obsidian Milling Block GD 5-Pack W14 TS150 A2 Obsidian Milling Block GD 5-Pack W14 TS150 D3 Obsidian Paste Stain Gray, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel BL4 Obsidian Milling Block GD 5-Pack W14 TS150 BL4 Obsidian Milling Block GD 5-Pack W14 No Mandrel C1 Obsidian Milling Block GD 5-Pack W14 TS150 B2 Obsidian Paste Stain A, 3g Obsidian Paste Stain B, 3g Obsidian Milling Block GD 5-Pack W14 No Mandrel C3 Obsidian Milling Block GD 5-Pack W14 TS150 B3 Obsidian Milling Block GD 5-Pack W14 TS150 D2 Obsidian Milling Block 5-Pack W14 TS150 BL1 Obsidian Paste Stain Orange, 3g Obsidian Milling Block 5-Pack W14 TS150 A3 Obsidian Fluorescent Low Glaze Powder, 5g Obsidian Milling Block GD 5-Pack W14 No Mandrel A2 Obsidian Milling Block GD 5-Pack W14 No Mandrel B1 Obsidian Stain and Glaze Starter Kit Obsidian Milling Block GD 5-Pack W14 TS150 BL1

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device