BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PRIME DENTAL MANUFACTURING, INC.

    Reg #: 1424442 · FEI: 3002811563 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    73
    Establishment Types
    2
    Classifications
    15

    Registration Details

    Registration Name
    PRIME DENTAL MANUFACTURING, INC.
    Registration Number
    1424442
    FEI Number
    3002811563
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4555 W Addison St
    City
    CHICAGO
    State
    IL
    ZIP
    60641
    Country
    US

    Regulatory Submissions

    510(k) Number
    K021524

    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
    Dam, Rubber EIE
    Material, Tooth Shade, Resin EBF
    Cement, Dental EMA
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Wax, Dental, Intraoral EGD
    Instrument, Ligature Tucking, Orthodontic ECP
    External Cleaning Solution PME
    Sealant, Pit And Fissure, And Conditioner EBC
    Crown, Preformed ELZ
    Agent, Tooth Bonding, Resin KLE
    Preparer, Root Canal Endodontic EKQ
    Material, Impression Tray, Resin EBH
    Accessories, Implant, Dental, Endosseous NDP
    Zinc Oxide Eugenol EMB
    Protector, Dental BRW

    Proprietary Names

    Prime Blend Ultra Light Cure Soft Dental Dam Dental Dam Prime-Dent Hema Desensitizer Prime-Dent Temporary Cement Prime-Dent Automix Dual Cure Luting Cement Prime-Dent Dual Cure Luting Cement Prime-Dent Non Eugenol Temporary Cement Prime-Dent Visible Light Cure Luting Cement Prime-Dent Glass Ionomer Light Cured Restorative Prime-Dent Glass Ionomer Restorative Prime-Dent Glass Ionomer Cement Prime-Paste APIG Pressure Indicating Gel Prime-Dent Megaset Prime-Dent Visible Light Cure Orthodontic Adhesive Prime-Dent One Step Orthodontic Adhesive Prime-Dent Dual Cure Glass Ionomer Band Cement Prime-Dent Light Cure Glass Ionomer Band Cement Prime-Dent Visible Chemical Cure Pit and Fissure Top Chain - Continues Top Cahin - Long Top Sticks Top Sticks - Minis Top Chain - Minis Prime-Dent White Fluoride Varnish Prime-Dent Visible Light Cure Pit and Fissure Prime-Dent Light Cure Core Build Up Material Prime-Core Prime-Dent Chemical Core Build Up Material Prime-Dent Automix Dual Cure Core Build Up Material Prime-Crown Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive Prime-Dent Chemical Cure Composite Restorative Material Prime-Dent Root Canal Filling Material RC-CREAM Prime-Dent Tray Adhesive Prime-Dent Alginate Flavoring Prime-Dent Porcelain Repair Kit Prime-Dent Parafil Prime-Dent Parafil Separator Prime-Dent Parafil Modifier Prime-Dent Parafil Stains Prime-Dent Silane Bond Enhancer Prime-Dent Parafil Gingiva Prime-Dent Surface Sealant Prime-Dent Parafil LAB Prime-Dent Etchant Gel Prime-Dent Porcelain Etchant Gel Prime-Dent Light Cure One Step Dentin/Enamel Bonding Adhesive Prime-Dent Light Cure Dentin/Enamel Bonding Adhesive Prime-Dent Parafil Modeler Prime-Dent Citric Acid Prime-Dent Self Etch Bonding Agent Prime-Dent Parafil Primer Prime-Dent Visible Light Cure Composite Restorative Material Prime-Dent Etchant Liquid Prime-Dent Visible Light Cure Micro-Hybrid Composite Prime-Dent Visible Light Cure Nano-Hybrid Composite Prime-Dent Visible Light Cure Hybrid Composite Prime-Dent Visible Light Cure Flowable Composite Prime-Dent Brush Holder Prime-Dent Mixing Tips Prime-Dent Long Brushes Prime-Dent Short Shank Brushes Prime-Crown Mixing Tips Prime-Dent Luer Lock Dispensing Needle Tips Prime-Dent Mixing Spatulas Prime-Dent Mixing Pads Prime Dent Zinc Oxide Eugenol Reinforced Cement Prime Dent Zinc Oxide Eugenol Cement Prime Dent Zinc Phosphate Cement Prime Gel

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)