PULPDENT CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1215305	1215305	PULPDENT CORPORATION	1	Y	2026-01-01	80 Oakland St Watertown MA US 02472

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
29912	1269737844	K993683	PULPDENT UNO-DUO	KLE	1999-12-13
29912	1469359784	K974014	PULPDENT DENTASTIC UNO	EMA	1997-12-17
29912	1584658061	K972445	PULPDENT OX-OUT	EMA	1997-10-02
29912	1469425902	K971594	FLOW-RITE	EBF	1997-09-12
29912	1514273771	K964430	PULPDENT SNOOP	LFC	1997-01-17
29912	1292749440	K963652	PULPDENT DESENSITIZER	EBF	1996-10-11
29912	1682081986	K962747	PULPDENT ENDODONTIC POST CEMENT KIT	EMA	1996-09-30
29912	1270892265	K962383	PULPDENT RESILUTE II	EMA	1996-09-03
29912	2067539274	K961089	PULPDENT ENDOPREP II	EKL	1996-04-23
29912	1578363012	K953079	LIMELIGHT	EJK	1995-08-07
29912	1118367722	K952854	PULPDENT GLASS IONOMER CEMENTS	DYH	1995-07-14
29912	2019101954	K951270	PULPDENT GLASS IONOMER CEMENTS	EMA	1995-05-31
29912	1546866496	K946138	PULPDENT ROOT CANAL SEALER	KIF	1995-01-20
29912	1383358289	K945056	PULPDENT RESIN CEMENT	EBF	1994-12-14
29912	1877445448	K944945	PULPDENT CALCIUM HYDROXIDE PREPARATIONS	EJK	1994-11-30
29912	1836589900	K932794	PULPDENT SEAL-RITE LOW VISCOSITY	EBC	1993-09-20
29912	1045751377	K932793	PULPDENT 2.5% NITRIC ACID ETCHANT	EBF	1993-09-13
29912	1227566418	K931710	PULPDENT DENTAL BOND ENHANCER 2-B	KLE	1993-08-24
29912	1333210561	K930989	PULPDENT UNFILLED DUAL CURE BONDING RESIN	KLE	1993-04-20
29912	1821615884	K926074	PULPDENT DENTAL BOND ENCHANCER	EBF	1993-03-16
29912	1384698866	K922755	PULPDENT HARD CORE	EBF	1992-08-20
29912	1716219256	K920483	10% PHOSPHORIC ACID ETCHING GEL	EBF	1992-04-29
29912	1067536376	K911287	PULPDENT SEAL RITE	EBC	1991-06-10
29912	1223761895	K911286	PULPDENT ORTHODONTIC BRACKET ADHESIVE	DYH	1991-07-05
29912	2045000431	K911282	PULPDENT ENAMEL BONDING AGENT	KLE	1991-09-06
29912	1053139592	K911281	PULPDENT PIC N STIC	EKJ	1991-05-15
29912	1096838860	K902023	SEAL RITE PROCEDURE KIT(TM)	EBC	1990-07-13
29912	2032013681	K901051	22% POLYACRYLIC ACID GEL	EBF	1990-04-30
29912	1206380105	K901049	COPAL VARNISH	LBH	1990-05-29
29912	1205114166	K896659	SILANE	KLE	1990-02-14
29912	1952346765	K896655	9.6% HYDROFLUORIC ACID GEL	KLE	1990-02-14
29912	1401277348	K896654	DRYING AGENT	EBF	1990-02-14
29912	1192593471	K882576	ACID ETCH GEL	EBF	1988-07-15
29912	1554355255	K853447	POLYCARB WATER SET	EMA	1985-10-16
29912	1770044379	K810545	PCA PERIOCARE PERIODONTAL DRESSING	EMA	1981-03-24
29912	1102390766	K153249	Pulpdent Solo Flowable Composite with MCP	EBF	2016-04-01
29912	1184555744	K130223	RMGI FILL	EMA	2013-03-29
29912	1708217737	K123265	RMGI LOW VISCOSITY	EMA	2012-12-07
29912	1863541033	K120784	TUFF-TEMP 2.0	EBG	2012-06-08
29912	1454186604	K120003	NUCAL	EJK	2012-04-05
29912	1344991612	K112946	ACTIV VARNISH	LBH	2011-12-09
29912	1589390968	K093620	PULPDENT FLUORIDE VARNISH	LBH	2010-03-10
29912	1868282668	K090391	PULPDENT MICRO-HYBRID COMPOSITE	EBF	2009-05-11
29912	1858590071	K081810	PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL	EBG	2008-09-17
29912	1136558400	K071278	EMBRACE DUAL CURE COMPOSITE MATERIALS	EBF	2007-06-29
29912	1559912216	K052281	EMBRACE WETBOND CLEAR SEALANT	EBC	2006-02-08
29912	1595587999	K040236	PULPDENT VLC RESIN CEMENT	EMA	2004-04-20
29912	1812755402	K032953	EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT	KLE	2003-12-10
29912	1134704360	K031915	PULPDENT ETCH-RITE ROYALE	KLE	2003-08-05
29912	1314304426	K031877	EMBRACE WET-BOND RESTORATIVE MATERIAL	EBF	2003-08-01
29912	1043154620	K022734	PULPDENT CALCIUM HYDROXIDE PREPARATION	KIF	2002-10-07
29912	1769297902	K022522	PULPDENT PUTTY DAM	EIE	2002-09-26
29912	1935346697	K022492	PULPDENT SEMI-GEL ETCH	EBF	2002-10-11
29912	1417757682	K020481	PULPDENT POST CEMENT	EMA	2002-04-17
29912	1533541832	K020432	PULPDENT GLAZE	EBF	2002-04-17
29912	2067348095	K020287	DENTITION INTEGRATING MATERIAL	EBC	2002-04-12
29912	1054556080
29912	1069840318
29912	1081610021
29912	1123705582
29912	1158527622
29912	1235933786
29912	1263288084
29912	1310062201
29912	1341068982
29912	1390241208
29912	1559680326
29912	1608760887
29912	1639338101
29912	1655764309
29912	1695686561
29912	1763230328
29912	1783426368
29912	1803576847
29912	1909133318
29912	1947971646
29912	1952524644
29912	1993099176
29912	2040435616

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
EBF	16	2016-04-01
EMA	11	2013-03-29
KLE	8	2003-12-10
EBC	5	2006-02-08
EJK	3	2012-04-05
LBH	3	2011-12-09
EBG	2	2012-06-08
KIF	2	2002-10-07
DYH	2	1995-07-14
EIE	1	2002-09-26
LFC	1	1997-01-17
EKL	1	1996-04-23
EKJ	1	1991-05-15

GUDID#

DENTIN CONDITIONING GEL - 22% POLYACRYLIC ACIDKIT: 4 x 1.2 mL syringes + 8 pre-bent needles
PULPDENT CORPORATION
2016-07-21
ETCH-ALL™ - Dental Etching Gel - 10% PHOSPHORIC ACIDKIT: 4 x 1.2 mL syringes + 8 pre-bent applicator tips
PULPDENT CORPORATION
2016-09-01
ETCH-ALL™ Dental Etching Gel - 5 mL syringe 10% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH ROYALE™ DENTAL ETCHING GEL - KIT: 4 x 1.2 mL syringes + 20 pre-bent applicator tips37% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH ROYALE™ DENTAL ETCHING GEL - Bulk Pack: 1.2 mL syringes, pkg. of 24, no tips37% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH ROYALE™ DENTAL ETCHING GEL - Jumbo Kit: 2 x 25 mL syringes gel (64 gm), 5 x 3 mL empty syringes, 50 applicator tips37% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
Etch Royale - Dental Etching Gel 37% Phosphoric AcidJumbo Refill: 2x25mL (69gm) syringes
PULPDENT CORPORATION
2016-09-01
ETCH ROYALE™ DENTAL ETCHING GEL - 6 mL (8.3 gm) syringe37% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH-RITE™ DENTAL ETCHING GEL - 12 mL (16.6 gm) syringe38% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH-RITE™ DENTAL ETCHING GEL - 12 gm (8.7mL) syringe38% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCHANT - SEMI-GEL, 35% PHOSPHORIC ACID18 gm bottle
PULPDENT CORPORATION
2016-09-01
ETCH-RITE™ DENTAL ETCHING GEL - Bulk Pack 1.2 mL syringes - pkg. of 24 - no tips38% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH-RITE™ DENTAL ETCHING GEL - Jumbo Kit: 2x25 mL syringes gel (69 gm), 5 x 3 mL empty syringes, 50 tips38% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH-RITE™ DENTAL ETCHING GEL - Jumbo Refill: 2x25 mL (69 gm) syringe38 Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ETCH-RITE™ DENTAL ETCHING GEL - 6 mL (8.3 gm) syringe38% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH-RITE™ DENTAL ETCHING GEL - KIT: 4 x 1.2 mL syringes + 8 pre-bent applicator tips 38% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH-RITE™ DENTAL ETCHING GEL - Twin Pack: 2 x 3 mL syringes + 25 applicator tips 38% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH ROYALE SAMPLE - 0.6 mL syringe + mixing tips
PULPDENT CORPORATION
2018-08-10
ETCH RITE SAMPLE - 0.6 mL syringe + mixing tips
PULPDENT CORPORATION
2018-08-10
ETCH-RITE™ DENTAL ETCHING GEL - Clinic Pack: 1.2 mL syringe package of 144 - no applicator tips38% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
Etch Rite - Etch Rite phosphoric acid etchant; 3 x 3mL syringes + 40 25gauge bent needle tips.
PULPDENT CORPORATION
2021-05-17
ETCH-ALL™ Dental Etching Gel - 6 mL syringe10% Phosphoric Acid
PULPDENT CORPORATION
2016-07-28
ETCH ROYALE™ DENTAL ETCHING GEL - 12 gm (8.7 mL) syringe37% Phosphoric Acid
PULPDENT CORPORATION
2016-08-11
ACTIVA™ BioACTIVE Bulk Flow - 2 x 3 mL / 5 gm syringes + 20 Automix tips, Universal Shade
PULPDENT CORPORATION
2025-05-12
ACTIVA™ Kids BioACTIVE Bulk Flow - 2 + 3 mL / 5 gm syringes + 20 Automix tips, Universal Shade
PULPDENT CORPORATION
2025-05-12
Applicator Tips - Automix Tips, clear, with bendable 19-gauge metal cannula - Pkg of 20
PULPDENT CORPORATION
2024-12-03
Applicator Tips - Automix Tips, clear, with bendable 19-gauge metal cannula - Pkg of 20
PULPDENT CORPORATION
2024-12-03
ACTIVA™ BioACTIVE Bulk Flow - 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample
PULPDENT CORPORATION
2024-12-02
ACTIVA™ Kids BioACTIVE Bulk Flow - 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample
PULPDENT CORPORATION
2024-12-02
ACTIVA™ BioACTIVE Bulk Flow - 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)
PULPDENT CORPORATION
2024-12-02
ACTIVA™ Kids BioACTIVE Bulk Flow - 1 x 3mL / 5gm syringe + 10 Automix tips, opaque white shade
PULPDENT CORPORATION
2024-12-02
ACTIVA™ Kids BioACTIVE Bulk Flow - 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)
PULPDENT CORPORATION
2024-12-02
Endo Ruler - Endo Ruler - Plastic
PULPDENT CORPORATION
2021-09-23
DENTASTIC UNO SAMPLE - Adhesive, dentine, applicator brush
PULPDENT CORPORATION
2018-08-10
DenTASTIC® - Refill Kit - 6 ML EACH DENTASTIC ADHESIVE PRIMER PARTS A,B,C6 ML EACH UNFILLED RESIN BONDING AGENT PARTS 1 AND 25 ML ETCH ALL, 10% PHOSPHORIC ACID ETCH GEL
PULPDENT CORPORATION
2016-07-21
Wedges - Fintrec transparent (pkg. of 250). Silver coated, Daisy wheel package
PULPDENT CORPORATION
2021-09-21
Wedges - Starter Kit - box of 400, 4 assorted colors
PULPDENT CORPORATION
2021-09-21
Wedges - REFILL – bag of 100, Blue=12mm
PULPDENT CORPORATION
2021-09-21
Wedges - REFILL – bag of 100, Green=13mm
PULPDENT CORPORATION
2021-09-21
Wedges - REFILL – bag of 100, White=17mm
PULPDENT CORPORATION
2021-09-21

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