BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Glidewell™ 3DP Denture Teeth Resin Shade C2

    Reg #: 3011649314 · FEI: 3011649314 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    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

    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
    Additively Manufactured, Preformed, Resin Denture Tooth PZY

    Proprietary Names

    Glidewell™ 3DP Denture Teeth Resin Shade C2 Glidewell™ 3DP Denture Teeth Resin Shade C1 Glidewell™ 3DP Denture Teeth Resin Shade A3 Glidewell™ 3DP Denture Teeth Resin Shade C4 Glidewell™ 3DP Denture Teeth Resin Shade B3 Glidewell™ 3DP Denture Teeth Resin Shade A1 Glidewell™ 3DP Denture Teeth Resin Shade C3 Glidewell™ 3DP Denture Teeth Resin Shade D3 Glidewell™ 3DP Denture Teeth Resin Shade A2 Glidewell™ 3DP Denture Teeth Resin Shade B2 Glidewell™ 3DP Denture Teeth Resin Shade A4 Glidewell™ 3DP Denture Teeth Resin Shade A3.5 Glidewell™ 3DP Denture Teeth Resin Shade BL1 Glidewell™ 3DP Denture Teeth Resin Shade B1 Glidewell™ 3DP Denture Teeth Resin Shade D2

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device