BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prime-Dent Chemical Cure Composite Restorative Material

    Reg #: 1424442 · FEI: 3002811563 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    PRIME DENTAL MANUFACTURING, INC.
    Registration Number
    1424442
    FEI Number
    3002811563
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4555 W Addison St
    City
    CHICAGO
    State
    IL
    ZIP
    60641
    Country
    US

    Regulatory Submissions

    510(k) Number
    K994224

    Owner / Operator

    Firm Name
    PRIME DENTAL MANUFACTURING, INC.
    Operator Number
    9039081
    Address
    4555 WEST ADDISON STREET, --
    City
    Chicago
    State
    IL
    Postal Code
    60641
    Country
    US
    Correspondent
    Pedro - Segura

    Products

    Device Name Product Code
    Material, Tooth Shade, Resin EBF
    Agent, Tooth Bonding, Resin KLE

    Proprietary Names

    Prime-Dent Chemical Cure Composite Restorative Material Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive

    Establishment Types

    Manufacture Medical Device