BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PULPDENT CORPORATION

    Reg #: 1215305 · FEI: 1215305 · Expires 2026
    View on FDA
    Products
    37
    Proprietary Names
    130
    Establishment Types
    3
    Classifications
    37

    Registration Details

    Registration Name
    PULPDENT CORPORATION
    Registration Number
    1215305
    FEI Number
    1215305
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    80 Oakland St
    City
    Watertown
    State
    MA
    ZIP
    02472
    Country
    US

    Regulatory Submissions

    510(k) Number
    K090391

    Owner / Operator

    Firm Name
    PULPDENT CORPORATION
    Operator Number
    1215305
    Address
    80 OAKLAND ST.
    City
    Watertown
    State
    MA
    Postal Code
    02472
    Country
    US
    Correspondent
    MARJORIE A COTE

    Products

    Device Name Product Code
    File, Pulp Canal, Endodontic EKS
    Material, Tooth Shade, Resin EBF
    Remover, Crown EIS
    Varnish, Cavity LBH
    Cement, Dental EMA
    Coating, Filling Material, Resin EBD
    Agent, Tooth Bonding, Resin KLE
    Needle, Dental DZM
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Crown And Bridge, Temporary, Resin EBG
    Forceps, Articulation Paper EFK
    Zinc Oxide Eugenol EMB
    Applicator, Resin KXR
    Carrier, Amalgam, Operative EKI
    Liner, Cavity, Calcium Hydroxide EJK
    Sealant, Pit And Fissure, And Conditioner EBC
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Resin, Root Canal Filling KIF
    Retainer, Matrix JEP
    Mirror, Mouth EAX
    Plugger, Root Canal, Endodontic EKR
    Material, Impression Tray, Resin EBH
    Point, Silver, Endodontic EKL
    Frame, Rubber Dam EJE
    Pliers, Operative EJY
    Device, Caries Detection LFC
    Scissors, Medical, Disposable JOK
    Paper, Articulation EFH
    Pin, Retentive And Splinting, And Accessory Instruments EBL
    Dam, Rubber EIE
    Burnisher, Operative EKJ
    Mixer, Cement, For Clinical Use JDZ
    Scaler, Periodontic EMN
    Instruments, Dental Hand DZN
    Syringe, Restorative And Impression Material EID
    Carver, Wax, Dental EIK
    Preparer, Root Canal Endodontic EKQ

    Proprietary Names

    17% SOLUTION EDTA SHOWCASE Nano-Microhybrid Composite CROWN REMOVER Embrace Varnish Chemlock Cement R-Bond Bonding Agent PolyCarb WaterSet Cement Embrace WetBond First-Coat Embrace WetBond Seal-n-Shine Embrace WetBond Restoration & PFM K Applicator tips Pressure syringe needles Sparkle Diamond Polishing Paste Tuff-Temp Provisional Glaze Tuff-Temp Provisional C & B Resin Tuff-Temp Provisional Add-On Dentin Desensitizer Fluoride Varnish DenTASTIC UNO Embrace WetBond Resin Cement Med Vi Embrace WetBond Resin Cement Low Vi Porcelain Etch Gel Porcelain Prep Kit MILLER FORCEPS, CURVED EUGENOL ZINC OXIDE Tuff-Temp Plus Provisional Veneer, Crown & Bridge Resin Pulpdent Brush tips Pulpdent Long-Handle Brush ACTIVA-SPENSER Pulpdent Brush Handle Core Forms PCA AMALGAM CARRIERS ACTIVA BioACTIVE CEMENT ACTIVA BioACTIVE BASE / LINER Seal-Rite Low Viscosity ORTHO-CHOICE BAND-RITE Forendo ACTIVA SOLO FLOWABLE LIME-LITE ENHANCED Pronto ACTIVA PRESTO Lime-Lite Enhanced Lime-Lite GlassCore GlassLute Ortho-Choice Glass Iono Band Cement GlassBase GlassLine GlassFill 'T'-Bands Fintrec Transparent Matrix Strip Fintrec Dead Soft Matrix Strip FLECTA DenTASTIC DUO Spee-Dee Build-Up Material Silane Bond Enhancer Root Canal Plugger Pulpdent Tray Adhesive OC Orthodontic Bracket Adhesive Ortho-Choice OBA EDTA, 17% SOLUTION File-Rite Prep-Rite RC Seal-Rite Procedure Kit PCA "DAM" FRAME DenTASTIC Unfilled Resin Bonding Agent CRIMPER CUTTER PLIERS Snoop Caries Detecting Dye One-Way Utility Scissors HardCore Core Build-Up Material Semi-Gel Etchant Dentin Conditioning Gel TempCanal Enhanced Pulpdent Etch Royale Dental Etching Bausch Arti-Fol Bausch Articulating Paper Double Check, 50 microns Bausch Arti-Spot Marking Liquid Bausch Arti-Fol Metallic Pulpdent Ox-Out Pulpdent Cavity Liner TempCanal Calcium Hydroxide Paste Multi-Cal Calcium Hydroxide Paste Pulpdent Paste PerfoMat SplintMat Rainbow Wedges Etch-Rite Ortho-Choice Ortho-Coat Flows-Rite Flowable Composite Embrace Esthetic Opaquers Embrace WetBond Class V Pulpdent Root Canal Sealer Powder Pulpdent Root Canal Sealer Kit Pulpdent Root Canal Sealer Liquid ACTIVA BioACTIVE RESTORATIVE ACTIVA KIDS BioACTIVE-RESTORATIVE ACTIVA BioACTIVE BULK FLOW ACTIVA KIDS BioACTIVE BULK FLOW KOOL-DAM PIC-N-STIC Mini-bowls, Non-Stick Silicone Bowls for Mixing Acrylics Mixing Wells, Disposable Flexible Scaler Etch-All 10% Phosphoric Acid Gel DenTASTIC Adhesive Primers A, B & C DenTASTIC Unfilled Resin Bonding Agents 1 & 2 DenTASTIC Adhesive System Kleer Veneer RESILUTE RESIN CEMENT Dry-Rite Drying Agent Seal-Rite Pit & Fissure Sealant Copal Varnish Glass Ionomer Varnish Embrace WetBond Pit & Fissure Seal Embrace Pit & Fissure Sealant DenTASTIC UNO-DUO ResiLute Resin Cement Universal Sha ResiLute Resin Cement Clear Shade J-POD Composite Condensing Instrument Brush tips and handles PerioCare Periodontal Dressing PRESSURE SYRINGE LAB CARVER Ortho-Choice OBA Bonding Resin Root Canal Spreader Dryer Root Canal Discs 2.5% Nitric Acid Etchant

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility