BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Camouflage Universal Enamel, Shade D4, 4g Syringe

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    59
    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
    K133850

    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
    Material, Tooth Shade, Resin EBF

    Proprietary Names

    Camouflage Universal Enamel, Shade D4, 4g Syringe Camouflage Universal Enamel Sample, Shade A2, 1g Syringe Camouflage Universal Incisal, 4g Syringe Camouflage Flowable Enamel, Bleach, 20 0.2g Capsules Camouflage Universal Dentin, Shade B1, 4g Syringe Camouflage Universal Enamel, Shade C3, 20 0.2g Capsules Camouflage Flowable Enamel, Shade C4, 4g Syringe Camouflage Flowable Dentin, Shade A2, 20 0.2g Capsules Camouflage Flowable Enamel, Shade C4, 20 0.2g Capsules Camouflage Universal Enamel Sample, Shade A2, 3 0.2g Capsules Camouflage Universal Enamel, Shade D4, 20 0.2g Capsules Camouflage Flowable Enamel, Shade B1, 20 0.2g Capsules Camouflage Universal Enamel, Bleach, 4g Syringe Camouflage Flowable Enamel, Shade A2, 20 0.2g Capsules Camouflage Universal Dentin, Shade A3, 4g Syringe Camouflage Flowable Enamel, Shade A1, 4g Syringe Camouflage Flowable Enamel, Shade A4, 4g Syringe Camouflage Universal Enamel, Shade B4, 4g Syringe Camouflage Universal Enamel, Shade C1, 20 0.2g Capsules Camouflage Universal Enamel, Shade D3, 4g Syringe Camouflage Universal Enamel, Shade D3, 20 0.2g Capsules Camouflage Universal Enamel, Shade B2, 4g Syringe Camouflage Universal Enamel, Shade B3, 20 0.2g Capsules Camouflage Universal Enamel, Shade C2, 20 0.2g Capsules Camouflage Universal Enamel, Shade B1, 20 0.2g Capsules Camouflage Universal Enamel, Shade B1, 4g Syringe Camouflage Universal Enamel, Shade B3, 4g Syringe Camouflage Flowable Enamel, Shade A3, 20 0.2g Capsules Camouflage Universal Dentin, Shade B1, 20 0.2g Capsules Camouflage Universal Enamel, Shade D2, 20 0.2g Capsules Camouflage Universal Dentin, Shade A2, 20 0.2g Capsules Camouflage Flowable Dentin, Shade A2, 4g Syringe Camouflage Universal Enamel, Shade C1, 4g Syringe Camouflage Universal Enamel, Shade C4, 20 0.2g Capsules Camouflage Universal Enamel, Shade C3, 4g Syringe Camouflage Flowable Enamel, Shade A4, 20 0.2g Capsules Camouflage Universal Enamel, Shade C4, 4g Syringe Camouflage Flowable Enamel, Shade A3, 4g Syringe Camouflage Universal Enamel, Shade A3.5, 4g Syringe Camouflage Universal Dentin, Shade A3, 20 0.2g Capsules Camouflage Universal Dentin, Shade A2, 4g Syringe Camouflage Universal Enamel, Shade B2, 20 0.2g Capsules Camouflage Universal Enamel, Shade A3.5, 20 0.2g Capsules Camouflage Flowable Enamel, Shade A3.5, 4g Syringe Camouflage Universal Enamel, Bleach, 20 0.2g Capsules Camouflage Universal Enamel, Shade D2, 4g Syringe Camouflage Universal Enamel, Shade A2, 20 0.2g Capsules Camouflage Universal Enamel, Shade A4, 20 0.2g Capsules Camouflage Universal Incisal, 20 0.2g Capsules Camouflage Universal Enamel, Shade C2, 4g Syringe Camouflage Flowable Enamel, Bleach , 4g Syringe Camouflage Flowable Enamel, Shade B1, 4g Syringe Camouflage Flowable Enamel, Shade A2, 4g Syringe Camouflage Universal Enamel Sample, Shade A2, 5 0.2g Capsules Camouflage Universal Enamel, Shade B4, 20 0.2g Capsules Camouflage Universal Enamel, Shade A3, 20 0.2g Capsules Camouflage Flowable Enamel, Shade A1, 20 0.2g Capsules Camouflage Universal Enamel, Shade A4, 4g Syringe Camouflage Flowable Enamel, Shade A3.5, 20 0.2g Capsules

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device