BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prime-Dent Parafil

    Reg #: 1424442 · FEI: 3002811563 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    1

    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
    K001108

    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

    Proprietary Names

    Prime-Dent Parafil Prime-Dent Parafil Separator Prime-Dent Parafil Modeler Prime-Dent Parafil LAB Prime-Dent Visible Light Cure Hybrid Composite Prime-Dent Citric Acid Prime-Dent Visible Light Cure Composite Restorative Material Prime-Dent Etchant Liquid Prime-Dent Visible Light Cure Nano-Hybrid Composite Prime-Dent Porcelain Repair Kit Prime-Dent Parafil Gingiva Prime-Dent Parafil Stains Prime-Dent Parafil Modifier Prime-Dent Visible Light Cure Flowable Composite Prime-Dent Self Etch Bonding Agent Prime-Dent Visible Light Cure Micro-Hybrid Composite Prime-Dent Porcelain Etchant Gel Prime-Dent Etchant Gel Prime-Dent Parafil Primer Prime-Dent Silane Bond Enhancer Prime-Dent Light Cure One Step Dentin/Enamel Bonding Adhesive Prime-Dent Surface Sealant Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive

    Establishment Types

    Manufacture Medical Device