Manufacturer registered with FDA

Pulpdent Corporation

Watertown, MA, United States. Lists 35 dental device types with FDA across 1 registered establishment, and holds 107 510(k) clearances as applicant.

FDA owner/operator1215305ManufacturerRepacker / relabelerSpecification developer

Device types listed: 35
Brands and models: 134
510(k) clearances: 1071990–2021
Markets registered in: 13342 registrations outside the US
Establishments: 1United States

510(k) clearances per year, 1990–2026

Registered in 13 markets

Where regulators' registries name Pulpdent Corporation as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Pulpdent Corporation	107 clearances	1990–2021	Below
Canada	Health Canada	Registration holder	PULPDENT CORPORATION	146	2002–2026	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Pulpdent Corporation	51	—	Pure Global AI
Taiwan	TFDA	Manufacturer	PULPDENT CORPORATIONPulpdent Corporation	26	2006–2019	Pure Global AI
Costa Rica	Ministerio de Salud	Manufacturer	Pulpdent Corporation	25	—	Pure Global AI
Australia	TGA	Manufacturer	Pulpdent Corporation	24	2003–2022	Pure Global AI
South Korea	MFDS	Manufacturer	PulpDent CorporationPULPDENT CORPORATION · Pulpdent Corporation · +2	23	1999–2011	Pure Global AI
European Union	EUDAMED	Manufacturer	Pulpdent Corporation	14	—	Pure Global AI
United Kingdom	MHRA	Manufacturer	Pulpdent Corporation	13	—	Pure Global AI
Brazil	ANVISA	Manufacturer	PULPDENT CORPORATION	12	2026–2026	Pure Global AI
China	NMPA	Registration holder	美国派丽登公司Pulpdent Corporation	6	—	Pure Global AI
Israel	AMAR	Manufacturer	Pulpdent Corporation	1	—	Pure Global AI
Philippines	FDA Philippines	Manufacturer	Pulpdent Corp.	1	2022–2022	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Pulpdent Corporation currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Maker	ACTIVA PRESTOACTIVA SOLO FLOWABLEDenTASTIC DUODentin Conditioning GelDentin DesensitizerDry-Rite Drying AgentEmbrace Esthetic OpaquersEmbrace WetBond Class VEmbrace WetBond First-CoatEmbrace WetBond Seal-n-Shine 11 more Etch-All 10% Phosphoric Acid GelEtch-RiteFlows-Rite Flowable CompositeHardCore Core Build-Up MaterialLIME-LITE ENHANCEDProntoRESILUTE RESIN CEMENTSemi-Gel EtchantSHOWCASE Nano-Microhybrid CompositeSpee-Dee Build-Up Material2.5% Nitric Acid Etchant	2008
Dental CementEMA · Class 2	Dental cements	Maker	ACTIVA BioACTIVE BASE / LINERACTIVA BioACTIVE BULK FLOWACTIVA BioACTIVE CEMENTACTIVA BioACTIVE RESTORATIVEACTIVA KIDS BioACTIVE BULK FLOWACTIVA KIDS BioACTIVE-RESTORATIVEChemlock CementDenTASTIC UNOEmbrace WetBond Resin Cement Low ViEmbrace WetBond Resin Cement Med Vi 14 more GlassBaseGlassCoreGlassFillGlassLineGlassLuteKleer VeneerOrtho-Choice Glass Iono Band CementPerioCare Periodontal DressingPolyCarb WaterSet CementPulpdent Ox-OutR-Bond Bonding AgentResiLute Resin Cement Clear ShadeResiLute Resin Cement Universal ShaSpee-Dee Build-Up Material	2008
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Maker	DenTASTIC Adhesive Primers A, B & CDenTASTIC Adhesive SystemDenTASTIC Unfilled Resin Bonding AgentDenTASTIC Unfilled Resin Bonding Agents 1 & 2DenTASTIC UNO-DUOEmbrace WetBond First-CoatEmbrace WetBond Restoration & PFM KEmbrace WetBond Seal-n-ShineOrtho-Choice OBA Bonding ResinPorcelain Etch Gel 3 more Porcelain Prep KitPulpdent Etch Royale Dental EtchingSilane Bond Enhancer	2008
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Maker	Embrace Pit & Fissure SealantEmbrace WetBond Pit & Fissure SealOrtho-Choice Ortho-CoatSeal-Rite Low ViscositySeal-Rite Pit & Fissure SealantSeal-Rite Procedure Kit	2008
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Maker	ACTIVA BioACTIVE BASE / LINERACTIVA BioACTIVE CEMENTLime-LiteMulti-Cal Calcium Hydroxide PastePulpdent Cavity LinerPulpdent PasteTempCanal Calcium Hydroxide PasteTempCanal Enhanced	2008
Cavity VarnishLBH · Class 2	Sealants & varnishes	Maker	Copal VarnishEmbrace VarnishFluoride VarnishGlass Ionomer Varnish	2009
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Maker	OC Orthodontic Bracket AdhesiveORTHO-CHOICE BAND-RITEOrtho-Choice OBA	2008
Resin Filling Material CoatingEBD · Class 2	—	Maker	Embrace WetBond First-CoatEmbrace WetBond Seal-n-ShineOrtho-Choice Ortho-Coat	2008
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Maker	Tuff-Temp Plus Provisional Veneer, Crown & Bridge ResinTuff-Temp Provisional Add-OnTuff-Temp Provisional C & B ResinTuff-Temp Provisional Glaze	2010
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Maker	ForendoPulpdent Root Canal Sealer KitPulpdent Root Canal Sealer LiquidPulpdent Root Canal Sealer Powder	2008
Dental NeedleDZM · Class 1	Dental needles & syringes	Maker	Applicator tipsPressure syringe needles	1989
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Maker	Brush tips and handlesJ-POD Composite Condensing Instrument	1987
Mouth MirrorEAX · Class 1	Dental hand instruments	Maker	FLECTA	2002
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Maker	Pulpdent Tray Adhesive	2023
Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1	—	Lister	PerfoMatRainbow WedgesSplintMat	2011
Articulation PaperEFH · Class 1	—	Lister	Bausch Arti-FolBausch Arti-Fol MetallicBausch Arti-Spot Marking LiquidBausch Articulating PaperDouble Check, 50 microns	1989
Articulation Paper ForcepsEFK · Class 1	Dental hand instruments	Lister	MILLER FORCEPS, CURVED	1989
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Maker	PRESSURE SYRINGE	2005
Rubber DamEIE · Class 1	Rubber dam systems	Maker	KOOL-DAM	2005
Dental Wax CarverEIK · Class 1	Dental hand instruments	Lister	LAB CARVER	1977
Crown RemoverEIS · Class 1	Dental hand instruments	Lister	CROWN REMOVER	1977
Rubber Dam FrameEJE · Class 1	Rubber dam systems	Maker	PCA "DAM" FRAME	1977
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Maker	Sparkle Diamond Polishing Paste	1989
Operative PliersEJY · Class 1	Dental hand instruments	Maker	CRIMPER CUTTER PLIERS	1977
Operative Amalgam CarrierEKI · Class 1	Dental hand instruments	Maker	PCA AMALGAM CARRIERS	1977
Operative BurnisherEKJ · Class 1	Dental hand instruments	Maker	PIC-N-STIC	2005
Endodontic Silver PointEKL · Class 1	—	Maker	EDTA, 17% SOLUTIONFile-RitePrep-Rite RC	2011
Root Canal Endodontic PreparerEKQ · Class 1	Endodontic files	Maker	Root Canal DiscsRoot Canal Spreader Dryer	1989
Endodontic Root Canal PluggerEKR · Class 1	Dental hand instruments	Lister	Root Canal Plugger	1989
Endodontic Pulp Canal FileEKS · Class 1	Endodontic files	Maker	EDTA17% SOLUTION	1996
Zinc Oxide EugenolEMB · Class 1	Dental cements	Lister	EUGENOLZINC OXIDE	1977
Periodontic ScalerEMN · Class 1	Dental hand instruments	Lister	Flexible Scaler	1987
Matrix RetainerJEP · Class 1	Dental hand instruments	Maker	Fintrec Dead Soft Matrix StripFintrec Transparent Matrix Strip'T'-Bands	1977
Resin ApplicatorKXR · Class 1	—	Maker	ACTIVA-SPENSERCore FormsPulpdent Brush HandlePulpdent Brush tipsPulpdent Long-Handle Brush	2015
Caries Detection DeviceLFC · Class 2	Caries detection devices	Maker	Snoop Caries Detecting Dye	2011

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Pulpdent Corporation as the applicant.

Decided	510(k)	Device	Device type
22 Sep 2021	K210045	ACTIVA PRESTO PACK	EBF Resin Tooth Shade Material
17 Jan 2018	K173020	OBA-MCP, Orthodontic Bracket Adhesive with MCP	DYH Resin Bracket and Tooth Conditioner Adhesive
5 Jan 2018	K172169	Pulpdent (Activa) Pit and Fissure Sealant with MCP	EBC Pit and Fissure Sealant and Conditioner
1 Apr 2016	K153249	Pulpdent Solo Flowable Composite with MCP	EBF Resin Tooth Shade Material
29 Mar 2013	K130223	RMGI FILL	EMA Dental Cement
7 Dec 2012	K123265	RMGI LOW VISCOSITY	EMA Dental Cement
8 Jun 2012	K120784	TUFF-TEMP 2.0	EBG Resin Temporary Crown and Bridge
5 Apr 2012	K120003	NUCAL	EJK Calcium Hydroxide Cavity Liner
30 Mar 2012	K120213	ETCH-RITE SUPREME	KLE Resin Tooth Bonding Agent
21 Mar 2012	K113818	EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL	EBC Pit and Fissure Sealant and Conditioner
5 Mar 2012	K113711	LIME-LITE II	EJK Calcium Hydroxide Cavity Liner
2 Mar 2012	K113617	SPEE-DEE PATCH	EBF Resin Tooth Shade Material
9 Dec 2011	K112946	ACTIV VARNISH	LBH Cavity Varnish
12 May 2010	K100503	PULPDENT COPAL VARNISH WITH FLUORIDE	LBH Cavity Varnish
10 Mar 2010	K093620	PULPDENT FLUORIDE VARNISH	LBH Cavity Varnish
11 May 2009	K090391	PULPDENT MICRO-HYBRID COMPOSITE	EBF Resin Tooth Shade Material
17 Sep 2008	K081810	PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL	EBG Resin Temporary Crown and Bridge
29 Jun 2007	K071278	EMBRACE DUAL CURE COMPOSITE MATERIALS	EBF Resin Tooth Shade Material
8 Feb 2006	K052281	EMBRACE WETBOND CLEAR SEALANT	EBC Pit and Fissure Sealant and Conditioner
20 Apr 2004	K040236	PULPDENT VLC RESIN CEMENT	EMA Dental Cement
10 Dec 2003	K032953	EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT	KLE Resin Tooth Bonding Agent
5 Aug 2003	K031915	PULPDENT ETCH-RITE ROYALE	KLE Resin Tooth Bonding Agent
1 Aug 2003	K031877	EMBRACE WET-BOND RESTORATIVE MATERIAL	EBF Resin Tooth Shade Material
12 Mar 2003	K030036	TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT	DYH Resin Bracket and Tooth Conditioner Adhesive
11 Oct 2002	K022492	PULPDENT SEMI-GEL ETCH	EBF Resin Tooth Shade Material
7 Oct 2002	K022734	PULPDENT CALCIUM HYDROXIDE PREPARATION	KIF Root Canal Filling Resin
26 Sep 2002	K022522	PULPDENT PUTTY DAM	EIE Rubber Dam
16 May 2002	K020514	PULPDENT GLAZE II	KLE Resin Tooth Bonding Agent
17 Apr 2002	K020481	PULPDENT POST CEMENT	EMA Dental Cement
17 Apr 2002	K020432	PULPDENT GLAZE	EBF Resin Tooth Shade Material
12 Apr 2002	K020287	DENTITION INTEGRATING MATERIAL	EBC Pit and Fissure Sealant and Conditioner
14 Mar 2002	K014138	PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT	DYH Resin Bracket and Tooth Conditioner Adhesive
14 Mar 2002	K014133	PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE	DYH Resin Bracket and Tooth Conditioner Adhesive
28 Feb 2002	K020115	PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM	DYH Resin Bracket and Tooth Conditioner Adhesive
27 Feb 2002	K014059	PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE	DYH Resin Bracket and Tooth Conditioner Adhesive
12 Dec 2001	K013411	PULPDENT CAVITY PREPARATION IV	LBH Cavity Varnish
2 Mar 2000	K994180	PULPDENT CAVITY PREPARATION III	LBH Cavity Varnish
29 Feb 2000	K994181	PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE	LBH Cavity Varnish
23 Feb 2000	K994182	PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE	LBH Cavity Varnish
13 Dec 1999	K993683	PULPDENT UNO-DUO	KLE Resin Tooth Bonding Agent
19 Mar 1998	K974202	PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS	LBH Cavity Varnish
18 Feb 1998	K974398	PULPDENT CAVITY VARNISH	LBH Cavity Varnish
17 Dec 1997	K974014	PULPDENT DENTASTIC UNO	EMA Dental Cement
2 Oct 1997	K972445	PULPDENT OX-OUT	EMA Dental Cement
12 Sep 1997	K971594	FLOW-RITE	EBF Resin Tooth Shade Material
17 Jan 1997	K964430	PULPDENT SNOOP	LFC Caries Detection Device
12 Nov 1996	K963921	PULPDENT SEAL-RITE UDMA	EBC Pit and Fissure Sealant and Conditioner
11 Oct 1996	K963652	PULPDENT DESENSITIZER	EBF Resin Tooth Shade Material
30 Sep 1996	K962747	PULPDENT ENDODONTIC POST CEMENT KIT	EMA Dental Cement
3 Sep 1996	K962383	PULPDENT RESILUTE II	EMA Dental Cement
23 Apr 1996	K961089	PULPDENT ENDOPREP II	EKL Endodontic Silver Point
1 Dec 1995	K955017	PULPDENT RESILUTE	EMA Dental Cement
25 Aug 1995	K953301	DENTASTIC ONE-STEP	EMA Dental Cement
25 Aug 1995	K953272	PULPDENT DENTASTIC II	EMA Dental Cement
25 Aug 1995	K953217	PULPDENT TOUCHDOWN	DYH Resin Bracket and Tooth Conditioner Adhesive
7 Aug 1995	K953079	LIMELIGHT	EJK Calcium Hydroxide Cavity Liner
19 Jul 1995	K952960	PULPDENT POST CEMENT	EMA Dental Cement
14 Jul 1995	K952854	PULPDENT GLASS IONOMER CEMENTS	DYH Resin Bracket and Tooth Conditioner Adhesive
31 May 1995	K951270	PULPDENT GLASS IONOMER CEMENTS	EMA Dental Cement
26 Jan 1995	K946137	PULPDENT PERIODONTAL DRESSINGS	EMA Dental Cement
20 Jan 1995	K946138	PULPDENT ROOT CANAL SEALER	KIF Root Canal Filling Resin
20 Jan 1995	K940368	CANAL KING (THIN) CANAL KING (THICK)	KIF Root Canal Filling Resin
17 Jan 1995	K945378	PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT	EBC Pit and Fissure Sealant and Conditioner
15 Dec 1994	K945173	PULPDENT HARDSHELL	EBF Resin Tooth Shade Material
14 Dec 1994	K945113	PULPDENT CERVICAL RESTORATIVE	EBF Resin Tooth Shade Material
14 Dec 1994	K945112	PULPDENT DUAL CURE UNFILLED BONDING RESIN	KLE Resin Tooth Bonding Agent
14 Dec 1994	K945058	PULPDENT MICROFILLED ANTERIOR COMPOSITE	EBF Resin Tooth Shade Material
14 Dec 1994	K945057	PULPDENT HYBRID ANTERIOR COMPOSITE	EBF Resin Tooth Shade Material
14 Dec 1994	K945056	PULPDENT RESIN CEMENT	EBF Resin Tooth Shade Material
14 Dec 1994	K945018	PULPDENT HARD DENTAL POSTERIOR FILLING MATERIAL	EBF Resin Tooth Shade Material
30 Nov 1994	K944945	PULPDENT CALCIUM HYDROXIDE PREPARATIONS	EJK Calcium Hydroxide Cavity Liner
20 Sep 1993	K932794	PULPDENT SEAL-RITE LOW VISCOSITY	EBC Pit and Fissure Sealant and Conditioner
20 Sep 1993	K932791	PULPDENT EDTA PREPARATIONS	KIF Root Canal Filling Resin
13 Sep 1993	K932793	PULPDENT 2.5% NITRIC ACID ETCHANT	EBF Resin Tooth Shade Material
9 Sep 1993	K932792	PULPDENT MALEIC ACID ETCHANTS	EBF Resin Tooth Shade Material
24 Aug 1993	K931710	PULPDENT DENTAL BOND ENHANCER 2-B	KLE Resin Tooth Bonding Agent
20 Apr 1993	K930989	PULPDENT UNFILLED DUAL CURE BONDING RESIN	KLE Resin Tooth Bonding Agent
16 Mar 1993	K926074	PULPDENT DENTAL BOND ENCHANCER	EBF Resin Tooth Shade Material
20 Aug 1992	K922755	PULPDENT HARD CORE	EBF Resin Tooth Shade Material
29 Apr 1992	K920485	PUPLDENT ETCH N PREP	EBF Resin Tooth Shade Material
29 Apr 1992	K920483	10% PHOSPHORIC ACID ETCHING GEL	EBF Resin Tooth Shade Material
28 Apr 1992	K920484	2.5% NITRIC ACID ETCHING GEL	EBF Resin Tooth Shade Material
28 Apr 1992	K920482	14% HYDROFLUORIC ACID ETCHING GEL	EBF Resin Tooth Shade Material
28 Apr 1992	K920460	4% ACIDULATED PHOSPHATE FLUORIDE ETCHING GEL	ELL Porcelain Teeth
9 Oct 1991	K911285	PULPDENT POLYAMIDE DENTIN LINER	EME Surgical Biopsy Punch
6 Sep 1991	K911282	PULPDENT ENAMEL BONDING AGENT	KLE Resin Tooth Bonding Agent
5 Jul 1991	K911286	PULPDENT ORTHODONTIC BRACKET ADHESIVE	DYH Resin Bracket and Tooth Conditioner Adhesive
10 Jun 1991	K911287	PULPDENT SEAL RITE	EBC Pit and Fissure Sealant and Conditioner
30 May 1991	K911284	PULPDENT DIAMOND POLISH	EJR Oral Cavity Abrasive Polishing Agent
15 May 1991	K911281	PULPDENT PIC N STIC	EKJ Operative Burnisher
20 Jul 1990	K902022	SEAL RITE(TM)	EBC Pit and Fissure Sealant and Conditioner
13 Jul 1990	K902023	SEAL RITE PROCEDURE KIT(TM)	EBC Pit and Fissure Sealant and Conditioner
29 May 1990	K901049	COPAL VARNISH	LBH Cavity Varnish
7 May 1990	K901053	MIRROR SHIELD	EKJ Operative Burnisher
30 Apr 1990	K901051	22% POLYACRYLIC ACID GEL	EBF Resin Tooth Shade Material
19 Apr 1990	K901050	NO-STICK COMPOSITE INSTRUMENT DIP	EBD Resin Filling Material Coating
16 Apr 1990	K901052	PULPDENT OIL FREE SURFACE PREPARATION PASTE	EJR Oral Cavity Abrasive Polishing Agent
14 Feb 1990	K896663	ENDO-PREP	EKM Gutta-Percha
14 Feb 1990	K896662	AIR BLOCK	EBF Resin Tooth Shade Material
14 Feb 1990	K896661	KEN'S PROPHY GEL - REGULAR	EJR Oral Cavity Abrasive Polishing Agent
14 Feb 1990	K896659	SILANE	KLE Resin Tooth Bonding Agent
14 Feb 1990	K896658	DENTIN DISCLOSING GEL AND GEL REMOVER	EBF Resin Tooth Shade Material
14 Feb 1990	K896657	ROOT CANAL SEALER, MODIFIED GROSSMANS' FORMULA	KIF Root Canal Filling Resin
14 Feb 1990	K896656	ROOT CANAL SEALER, GROOSMANS' FORMULA BISMUTH	KIF Root Canal Filling Resin
14 Feb 1990	K896655	9.6% HYDROFLUORIC ACID GEL	KLE Resin Tooth Bonding Agent
14 Feb 1990	K896654	DRYING AGENT	EBF Resin Tooth Shade Material
14 Feb 1990	K896653	SEPARATING MEDIUM (POLYVINYL ALCOHOL)	EBF Resin Tooth Shade Material

Some of these clearances are listed with FDA today by another company: Dentsply Sirona, Inc. (5), NuSmile, Ltd. (1), Shofu Inc (1), Centrix, Inc. (1), ITENA Clinical (1).

Also lists devices cleared under other names

Pulpdent Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Pulpdent Corp. of America (3).

Decided	510(k)	Device	Applicant	Device type
15 Jul 1988	K882576	ACID ETCH GEL	Pulpdent Corp. of America	EBF Resin Tooth Shade Material
16 Oct 1985	K853447	POLYCARB WATER SET	Pulpdent Corp. of America	EMA Dental Cement
24 Mar 1981	K810545	PCA PERIOCARE PERIODONTAL DRESSING	Pulpdent Corp. of America	EMA Dental Cement

Registered establishments

Establishment	Location	What it does
PULPDENT CORPORATIONFDA reg. 1215305	Watertown, MA, United States	Manufacturer, Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 1215305). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.