PULPDENT CORPORATION

FDA Device Registration & Listing · Watertown, MA, US · Registration 1215305

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1215305
FEI Number
1215305
Entity Name
PULPDENT CORPORATION
City/State/Country
Watertown, MA, US
Establishment Address
80 Oakland St, Watertown, MA 02472, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PULPDENT CORPORATION (Owner Number: 1215305)
Owner / Operator Contact Address
80 OAKLAND ST., Watertown, MA 02472, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K920483
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EKS File, Pulp Canal, Endodontic Dental Class 1 872.4565 1996-08-21
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-08-26
EIS Remover, Crown Dental Class 1 872.4565 1977-12-19
LBH Varnish, Cavity Dental Class 2 872.3260 2012-07-20
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2008-01-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
DZM Needle, Dental Dental Class 1 872.4730 1989-02-16
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 1989-02-16
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2010-02-08
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-05-10
LBH Varnish, Cavity Dental Class 2 872.3260 2011-05-10
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
EFK Forceps, Articulation Paper Dental Class 1 872.4565 1989-02-16
EMB Zinc Oxide Eugenol Dental Class 1 872.3275 1977-12-19
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2013-06-19
KXR Applicator, Resin Dental Class 1 872.3140 2015-01-08
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 1977-12-19
EMA Cement, Dental Dental Class 2 872.3275 2013-07-23
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2013-07-23
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-01-16
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-01-22
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2008-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2016-11-29
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2008-01-22
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
JEP Retainer, Matrix Dental Class 1 872.4565 1977-12-19
EAX Mirror, Mouth Dental Class 1 872.4565 2002-01-15
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-05-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2009-05-06
EMA Cement, Dental Dental Class 2 872.3275 2009-05-06
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 1989-02-16
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2023-09-19
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2008-01-16
EKL Point, Silver, Endodontic Dental Class 1 872.3840 2011-05-10
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2008-01-16
EJE Frame, Rubber Dam Dental Class 1 872.6300 1977-12-19
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2012-10-24
EJY Pliers, Operative Dental Class 1 872.4565 1977-12-19
LFC Device, Caries Detection Dental Class 2 872.1740 2011-05-10
JOK Scissors, Medical, Disposable General Hospital Class 1 880.6820 1989-02-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2011-05-10
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2016-06-22
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2008-01-16
EFH Paper, Articulation Dental Class 1 872.6140 1989-02-15
EMA Cement, Dental Dental Class 2 872.3275 2008-01-16
EJK Liner, Cavity, Calcium Hydroxide Dental Class 2 872.3250 2008-01-16
EBL Pin, Retentive And Splinting, And Accessory Instruments Dental Class 1 872.3740 2011-07-27
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2010-10-19
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2009-05-06
EBC Sealant, Pit And Fissure, And Conditioner Dental Class 2 872.3765 2009-05-06
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16
KIF Resin, Root Canal Filling Dental Class 2 872.3820 2008-01-16
EMA Cement, Dental Dental Class 2 872.3275 2013-07-23
EIE Dam, Rubber Dental Class 1 872.6300 2005-12-28
EKJ Burnisher, Operative Dental Class 1 872.4565 2005-12-28
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2012-04-11
EMN Scaler, Periodontic Dental Class 1 872.4565 1987-08-04
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2008-01-16

Official Correspondent

MARJORIE COTE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PULPDENT CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K864976 Endo Technic Corp. SOLUSET CALCIUM DEMINERALIZING SOLUTION 1987-02-27
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01
K153476 Kuraray Noritake Dental, Inc. KATANA AVENCIA Block 2016-08-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1215305. Last updated year: 2026. Please use registration number 1215305 when referencing this establishment in official correspondence.
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