Registered with FDA

Jersey Dental Supplies

Lakewood, NJ, United States. Lists 40 dental device types with FDA across 1 registered establishment.

FDA owner/operator10050503Repacker / relabelerReprocessor

Device types listed: 40
Brands and models: 200
510(k) clearances: 0as applicant
Markets registered in: 1United States
Establishments: 1United States

Devices listed with FDA

What Jersey Dental Supplies currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Dental CementEMA · Class 2	Dental cements	Lister	BIFIX QMCALIBRA CEMENTCEMENT, DENTALCOE PAK AUTO MIX, REGULAR OR HARD SETDyract Flow RestorativeEQUIAFLOWABLE COMPOSITEFUJI DUETFUJI IFUJI IX GP 26 more FUJI VII CAPSULEGC FUJI IX GP EXTRAGC FUJI LINING LC PASTE PAKGC FUJICEMGC XLC-100 CAPSULEGLASIONOMER BASE CEMENTKetac Fil Plus AplicapKETAC-CEM MAXICAPLCRMIRACLE MIX POWDER/LIQUIDNEXUS 3NEXUS RMGIRELY X CERAMIC PRIMERRELYX RMGIPRiva SilverSUGLUE-10TEMP BOND NETEMP-BOND NE 2TEMPBOND CLEAR WITH TRICLOSANTEMPBOND CLEAR-2TEMPORARY DENTAL CEMENTUNICEM HM3M Protemp Cement Temporary Dental Cement3M RESIN CEMENT3M VITREBOND LIGHT CURE GLASS IONOMER/BASE3M VITREMER TRI-CURE GLASS IONOMER SYSTEM	2016
Resin Tooth Shade MaterialEBF · Class 2	Dental composites	Lister	Admira Fusion X-BaseBEAUTIFIL FLOW PLUSBEAUTIFIL IICERASMARTCHARISMA -- MODIFIEDCOMPOSITE 168 RESTORATIVE SYSTEMCOMPOSITE AND PORCELAIN POLISHING PASTE PROD. LINEDENTAL COMPOSITE RESTORATIVEDMC COMPOSITE 2ENAMEL AND PORCELAIN ETCH PRODUCT LINE 26 more ENAMICFILTEK BULK FILL FLOWABLE RESTORATIVEFILTEK BULK FILL POSTERIOR RESTROATIVEFUJI II LC CAPSULEG-aenialGradia PlusGrandioSO x-traHELIOMOLAR(R) DENTAL RESTORATIVEHERCULITE ULTRAHERCULITE XR & XRVIPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUEMATERIAL, TOOTH SHADE, RESINMETAMORPHOSISMULTILINK AUTOMIXNEXCOMP AND META ETCHANTPOINT 4 MODIFIEDPREMISE FLOWABLE MODIFIEDREVOLUTION FORMULA 2TETRIC EVOCERAM BULK FILLTETRIC FLOWTooth Shade Resin MaterialULTRA-ETCH ENAMEL PREPARATION PRODUCT LINEVariolink EstheticVenus Diamond Flow3M DENT II SYSTEM3M LVR SYSTEM	2016
Impression MaterialELW · Class 2	Impression materials	Lister	AFFINIS; HydroXtreme; Jet Bite; President Jet light / regular body; President Plus; President Plus JetAQUASIL EASY MIX PUTTY IMPRESSION MATERIALAquasil Ultra + Smart Wetting Impression MaterialAQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIALAQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIALDIMENSION PENTA H, DIMENSION PENTA H QUICKDIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVEELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTINGEXTRUDEFLEXTIME 18 more HYDROGUM 5IMPREGUM FIMPREGUM GARANT L DUOSOFTIMPREGUM PENTAImpregum Soft; Impregum Soft Quick StepIMPRESSION COMPOUNDIMPRINT VINYL POLYSILOXANE IMPRESSION MATERIALKERR VPS IMPRESSION MATERIALMaterial, ImpressionNEOCOLLOID, ORTHOPRINTPERMLASTIC 2POSITION PENTA, POSITION PENTA QUICKPRESIDENT TRAYRegisil; Reprosil; Tray AdhesiveTake 1 AdvancedTORPICALGINVINYL POLYSILOXANE IMPRESSION MATERIALZETAPLUS SOFT	2016
Resin Tooth Bonding AgentKLE · Class 2	Bonding agents	Lister	ADHESE UNIVERSALADPER PROMPT, ADPER PROMPT L-POPAGENT, TOOTH BONDING, RESINBeautiBondCLEARFIL PHOTO BONDCLEARFIL SE BONDCLEARFIL TRI-S BOND PLUSFUTURABOND DC/SINGLE DOSEFUTURABOND M+G-BOND 12 more G-Premio BONDGLUMA COMFORT BONDGLUMA DESENSITIZER/GLUMA 3 PRIMERHELIOBONDIBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELFMONOBOND PLUSOne Coat 7 Universal; One Coat 7 Universal, One Coat 7, One Coat 7 ActivatorOPTIBOND ALL-IN-ONEPRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEMSCOTCHBOND MULTI-PURPOSE- ADHESIVESILANE PRIMER3M DENT SYSTEM	2016
Resin Temporary Crown and BridgeEBG · Class 2	Temporary crown & bridge materials	Lister	CERASMARTGC PATTERN RESININTEGRITYLUXATEMP AUTOMIXProtemp Plus; Temp XN28STRUCTUR 2TELIO CS INLAY & TELIO CS ONLAYUNIFAST LC	2016
Pit and Fissure Sealant and ConditionerEBC · Class 2	Sealants & varnishes	Lister	BEAUTISEALANTDMC COMPOSITE 2G-aenialHELIOSEALMETAMORPHOSISUltraSeal XT hydroVenus Diamond Flow3M CLINPRO SEALANT	2016
Root Canal Filling ResinKIF · Class 2	Root canal filling materials	Lister	AdsealAH PLUS ROOT CANAL SEALERApexit Root Canal SealerMETAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLINGMETAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLINGRoot Canal Filling ResinSealapex Tubes, Sealapex Bulk Package, Sealapex Xpress Dual-Barrel SyringesTubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	2016
Rebasing Repairing Relining Denture ResinEBI · Class 2	Denture resins & teeth	Lister	COE COMFORTCOE SOFTGC RELINEKOOLINER IIRESIN, DENTURE, RELINING, REPAIRING, REBASING	2017
Porcelain PowderEIH · Class 2	Dental ceramics & zirconia	Lister	ENAMICIPS E.MAX CAD/IPS E.MAX ZIRCADIPS EMPRESSIPS EMPRESS 2ULTRADENT PORCELAIN ETCH	2016
Cavity VarnishLBH · Class 2	Sealants & varnishes	Lister	ADHESE UNIVERSALG-aenialVarnish, CavityVenus Diamond FlowVOCO PROFLUORID VARNISH	2017
Oral Cavity Abrasive Polishing AgentEJR · Class 1	Polishing & prophylaxis	Lister	GC MI PASTE PLUSMI PASTENUPRO PROPHY PASTE	2016
Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2	—	Lister	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESINGC FUJI ORTHO BAND PASTE REFILL	2019
Amalgam Dental CapsuleDZS · Class 1	—	Lister	Dispersalloy CapsulesTYTIN	2017
Resin Impression Tray MaterialEBH · Class 1	Impression trays	Lister	Emiluma; ULTRADENT LC BLOCK-OUT RESINIMPREGUM F ADHESIVE	2017
Ultraviolet Activator for PolymerizationEBZ · Class 2	Curing lights	Lister	BLUEPHASE STYLEVALO Cordless; VALO Cordless Accessory(Battery Charger,Rechargeable Batteries,Light Shield,Bracket Holder,Charging Unit	2019
All Types RetractorEIG · Class 1	Dental hand instruments	Lister	OPALDAMOPTRAGATE	2018
Amalgam AlloyEJJ · Class 2	—	Lister	NEW STETIC DENTAL AMALGAM ALLOYTYTIN	2017
MercuryELY · Class 2	—	Lister	NEW STETIC DENTAL AMALGAM ALLOYTYTIN	2017
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Lister	DSI Dental Implant System3 Dynamic TiBase	2020
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Lister	DSI Dental Implant System	2025
Dental Hand InstrumentsDZN · Class 1	Dental hand instruments	Lister	Palodent	2019
Resin Filling Material CoatingEBD · Class 2	—	Lister	CAULK DYCAL LIGHT CURED	2018
Dental Air-Powered HandpieceEFB · Class 1	Dental handpieces	Lister	KAVO SPRAY	2018
Extraoral with Timer X-Ray UnitEHD · Class 2	Dental X-ray units	Lister	NOMAD PRO X-RAY SYSTEM	2019
Abrasive DiskEHJ · Class 1	Polishing & prophylaxis	Lister	—	2016
Abrasive PointEHL · Class 1	Polishing & prophylaxis	Lister	ACRYPOINT; BROWNIE; BURBUTLER ALL CERAMIC ABRASIVE KIT; BURBUTLER CADMASTER KIT; CERAMASTER; CERAMISTE; CERAMISTE SOFT;	2019
Restorative and Impression Material SyringeEID · Class 1	Dental hand instruments	Lister	Penta ElastomerSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	2019
Calcium Hydroxide Cavity LinerEJK · Class 2	—	Lister	ULTRACAL XS	2022
Root Canal Endodontic PreparerEKQ · Class 1	Endodontic files	Lister	PREPARER, ROOT CANAL ENDODONTIC	2021
Ultrasonic ScalerELC · Class 2	Ultrasonic scalers	Lister	DENTSPLY CAVITRON SPS SCALER SYSTEM	2019
Root Canal PostELR · Class 1	Root canal filling materials	Lister	POST, ROOT CANAL	2019
Preformed CrownELZ · Class 1	—	Lister	CROWN, PREFORMED	2016
Zinc Oxide EugenolEMB · Class 1	Dental cements	Lister	ZINC OXIDE EUGENOL	2017
Matrix RetainerJEP · Class 1	Dental hand instruments	Lister	Automix	2018
Dental FlossJES · Class 1	Floss & interdental cleaners	Lister	UltraPak; UltraPak Kit	2022
Carboxymethylcellulose Sodium (40-100&) Denture AdhesiveKOQ · Class 1	—	Lister	ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (40-100&)	2026
Resin ApplicatorKXR · Class 1	—	Lister	Black Mini Brush Tips; Inspiral Brush Tips; Opal Red Tips; Opal Seal Tips	2022
Digital Extraoral Source X-Ray SystemMUH · Class 2	Dental X-ray units	Lister	DEXIS SENSOR	2019
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain ReliefMZW · Class 2	—	Lister	—	2016
Dental AmalgamOIV · Class 2	—	Lister	NEW STETIC DENTAL AMALGAM ALLOY	2019

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

Also lists devices cleared under other names

Jersey Dental Supplies 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: GC America Inc. (24), Sybron Dental Specialties (24), 3M Company (18), Dentsply Intl., Inc. (17), Ivoclar Vivadent, AG (11), Ultradent Products, Inc. (9), Voco GmbH (7), Heraeus Kulzer, LLC (6).

Decided	510(k)	Device	Applicant	Device type
1 Apr 2020	K200188	DSI Dental Implant System	DSI Dental Solutions Ltd	DZE Root-Form Endosseous Implant
29 Aug 2018	K180802	Meta P&Bond	Meta Biomed Co, Ltd	KLE Resin Tooth Bonding Agent
22 Aug 2018	K181312	GrandioSO x-tra	Voco GmbH	EBF Resin Tooth Shade Material
4 May 2018	K162021	3.0 Dynamic TiBase	Talladium Espana, SL	NHA Endosseous Dental Implant Abutment
8 Mar 2018	K173500	NMF004A	GC America Inc.	EBF Resin Tooth Shade Material
29 Jun 2017	K170896	Admira Fusion x-base	Voco GmbH	EBF Resin Tooth Shade Material
6 Feb 2017	K170330	3M Protemp Cement Temporary Dental Cement	3M Company	EMA Dental Cement
27 Jul 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	Sybron Dental Specialties	KIF Root Canal Filling Resin
12 Jul 2016	K153325	Gradia Plus	GC America Inc.	EBF Resin Tooth Shade Material
6 May 2016	K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	Sybron Dental Specialties	KIF Root Canal Filling Resin
14 Apr 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	Sybron Dental Specialties	KIF Root Canal Filling Resin
4 Mar 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	Dentply International, Inc.	ELW Impression Material
9 Dec 2015	K152243	One Coat 7 Universal	Coltene/Whaledent AG	KLE Resin Tooth Bonding Agent
20 Apr 2015	K143140	G-Premio BOND	GC America Inc.	KLE Resin Tooth Bonding Agent
25 Nov 2014	K142389	Variolink Esthetic	Ivoclar Vivadent, AG	EBF Resin Tooth Shade Material
8 Oct 2014	K131487	FLUOR PROTECTOR S	Ivoclar Vivadent, AG	LBH Cavity Varnish
1 Aug 2014	K141610	FUTURABOND M+	Voco GmbH	KLE Resin Tooth Bonding Agent
8 May 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
29 Apr 2014	K140125	NEW STETIC DENTAL AMALGAM ALLOY	New Stetic, SA	OIV Dental Amalgam
14 Mar 2014	K133824	CERASMART	GC America Inc.	EBF Resin Tooth Shade Material
11 Feb 2014	K133318	ADHESE UNIVERSAL	Ivoclar Vivadent, AG	KLE Resin Tooth Bonding Agent
30 May 2013	K130869	TAKE 1 ADVANCE	Sybron Dental Specialties	ELW Impression Material
19 Feb 2013	K123595	NEXUS RMGI	Sybron Dental Specialties	EMA Dental Cement
31 Jan 2013	K123397	MULTILINK AUTOMIX	Ivoclar Vivadent, AG	EBF Resin Tooth Shade Material
13 Dec 2012	K122269	ENAMIC	Vita Zahnfabrik H. Rauter GmbH & Co. Kg.	EIH Porcelain Powder
7 Dec 2012	K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	Heraeus Kulzer, LLC	KLE Resin Tooth Bonding Agent
29 Aug 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE	Ivoclar Vivadent, AG	EBF Resin Tooth Shade Material
19 Mar 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	3M Espe Dental Products	EBF Resin Tooth Shade Material
14 Oct 2011	K111980	CLEARFIL TRI-S BOND PLUS	Kuraray America, Inc.	KLE Resin Tooth Bonding Agent
14 Oct 2011	K111958	TETRIC EVOCERAM BULK FILL	Ivoclar Vivadent, AG	EBF Resin Tooth Shade Material
23 Sep 2011	K112517	ULTRASEAL XT HYDRO	Ultradent Products, Inc.	EBC Pit and Fissure Sealant and Conditioner
16 Sep 2011	K111782	BEAUTISEALANT	Shofu Inc	EBC Pit and Fissure Sealant and Conditioner
29 Aug 2011	K110756	BLUEPHASE STYLE	Ivoclar Vivadent, AG	EBZ Ultraviolet Activator for Polymerization
3 Jun 2011	K110508	SUGLUE-10	3M Espe AG	EMA Dental Cement
19 May 2011	K110302	ADHESIVE EXL-759	3M Espe AG	KLE Resin Tooth Bonding Agent
28 Apr 2011	K110582	VALO CORDLESS	Ultradent Products, Inc.	EBZ Ultraviolet Activator for Polymerization
5 Apr 2011	K110378	IMPRESSION COMPOUND	Sybron Dental Specialties	ELW Impression Material
14 Feb 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY	Ivoclar Vivadent, AG	EBG Resin Temporary Crown and Bridge
20 Jan 2011	K103351	DMC COMPOSITE 2	Sybron Dental Specialties	EBF Resin Tooth Shade Material
23 Aug 2010	K101603	BEAUTIFIL FLOW PLUS	Shofu Inc	EBF Resin Tooth Shade Material
22 Jun 2010	K100908	UNICEM HM	3M Espe AG Dental Products	EMA Dental Cement
12 May 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	3M Company	EBF Resin Tooth Shade Material
27 Jan 2010	K093484	PREMISE FLOWABLE MODIFIED	Sybron Dental Specialties	EBF Resin Tooth Shade Material
3 Sep 2009	K091635	VENUS DIAMOND FLOW	Heraeus Kulzer, LLC	EBF Resin Tooth Shade Material
22 Jul 2009	K091388	GCUC-505	GC America Inc.	EBF Resin Tooth Shade Material
17 Jun 2009	K091106	EQUIA	GC America Inc.	EMA Dental Cement
4 Jun 2009	K091019	SPEEDCEM	Ivoclar Vivadent, AG	EMA Dental Cement
28 May 2009	K090458	DEXIS SENSOR	Dexis, LLC	MUH Digital Extraoral Source X-Ray System
21 May 2009	K091023	METAMORPHOSIS	Sybron Dental Specialties	EBF Resin Tooth Shade Material
11 May 2009	K090826	MONOBOND PLUS	Ivoclar Vivadent, AG	KLE Resin Tooth Bonding Agent
17 Dec 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	3M Company	EBF Resin Tooth Shade Material
11 Dec 2008	K082671	HERCULITE ULTRA	Sybron Dental Specialties	EBF Resin Tooth Shade Material
11 Dec 2008	K082744	BEAUTIBOND	Shofu Inc	KLE Resin Tooth Bonding Agent
24 Jul 2008	K080814	VOCO PROFLUORID VARNISH	Voco GmbH	LBH Cavity Varnish
23 Jun 2008	K081664	NOMAD PRO X-RAY SYSTEM	Aribex	EHD Extraoral with Timer X-Ray Unit
7 Apr 2008	K080305	NEXCOMP AND META ETCHANT	Meta Biomed Co, Ltd	EBF Resin Tooth Shade Material
26 Mar 2008	K080514	PECD-01 AND PECD QUICK-01	3M Espe AG Dental Products	ELW Impression Material
29 Jan 2008	K073209	MAXCEM 2	Sybron Dental Specialties	MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering for Pain Relief
23 Jan 2008	K073173	SELF-ADHESIVE RESIN CEMENT	Dentsply Interntional	EMA Dental Cement
9 Jan 2008	K073296	TEMPXN28	3M Espe AG Dental Products	EBG Resin Temporary Crown and Bridge
15 Aug 2007	K071742	BEAUTIFIL II	Shofu Inc	EBF Resin Tooth Shade Material
7 Jun 2007	K070723	FUTURABOND DC/SINGLE DOSE	Voco GmbH	KLE Resin Tooth Bonding Agent
12 Apr 2007	K070854	GC MI PASTE PLUS	GC America Inc.	EJR Oral Cavity Abrasive Polishing Agent
29 Mar 2007	K070698	COE COMFORT	GC America Inc.	EBI Rebasing Repairing Relining Denture Resin
29 Mar 2007	K070697	COE SOFT	GC America Inc.	EBI Rebasing Repairing Relining Denture Resin
26 Feb 2007	K070319	GC FUJI IX GP EXTRA	GC America Inc.	EMA Dental Cement
19 Oct 2006	K062519	NEXUS 3	Sybron Dental Specialties	EMA Dental Cement
14 Jul 2006	K061535	GC XLC-100 CAPSULE	GC America Inc.	EMA Dental Cement
2 May 2006	K060894	BIFIX QM	Voco GmbH	EMA Dental Cement
24 Apr 2006	K060684	ADPER PROMPT, ADPER PROMPT L-POP	3M Espe AG Dental Products	KLE Resin Tooth Bonding Agent
28 Mar 2006	K060469	OPTIBOND ALL-IN-ONE	Sybron Dental Specialties	KLE Resin Tooth Bonding Agent
3 Feb 2006	K053565	TEMPBOND CLEAR WITH TRICLOSAN	Sybron Dental Specialties	EMA Dental Cement
14 Oct 2005	K051705	IPS E.MAX CAD/IPS E.MAX ZIRCAD	Ivoclar Vivadent, AG	EIH Porcelain Powder
27 Sep 2005	K052235	LCR	3M Company	EMA Dental Cement
15 Jul 2005	K051424	HYDROGUM 5	Dentsply Sirona, Inc.	ELW Impression Material
15 Apr 2005	K050604	KERR VPS IMPRESSION MATERIAL	Sybron Dental Specialties	ELW Impression Material
15 Dec 2004	K043131	TORPICALGIN	Dentsply Sirona, Inc.	ELW Impression Material
7 Dec 2004	K042452	RIVA SILVER	Southern Dental Industries, Inc.	EMA Dental Cement
24 Nov 2004	K042769	ADSEAL ROOT CANAL SEALER	Meta Biomed Co, Ltd	KIF Root Canal Filling Resin
20 Oct 2004	K042200	MI PASTE	GC America Inc.	EJR Oral Cavity Abrasive Polishing Agent
18 Oct 2004	K041272	DYRACT CEM PLUS CEMENT	Dentsply Intl., Inc.	EMA Dental Cement
29 Jun 2004	K041471	G-BOND	GC America Inc.	KLE Resin Tooth Bonding Agent
16 Jun 2004	K040906	CALIBRA CEMENT	Dentsply Intl., Inc.	EMA Dental Cement
8 Oct 2003	K032605	METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING	Meta Biomed Co, Ltd	KIF Root Canal Filling Resin
7 Oct 2003	K032603	METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING	Meta Biomed Co, Ltd	KIF Root Canal Filling Resin
18 Dec 2002	K024041	ZETAPLUS SOFT	Dentsply Sirona, Inc.	ELW Impression Material
2 Aug 2002	K022476	RELYX RMGIP	3M Company	EMA Dental Cement
26 Jun 2002	K012308	KAVO QUATTROCARE	Kavo America	EFB Dental Air-Powered Handpiece
13 May 2002	K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	Dentsply Intl., Inc.	ELW Impression Material
10 May 2002	K021413	AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL	Dentsply Intl., Inc.	ELW Impression Material
28 Feb 2002	K020117	GC FUJI LINING LC PASTE PAK	GC America Inc.	EMA Dental Cement
18 Jan 2002	K013510	POINT 4 MODIFIED	Sybron Dental Specialties	EBF Resin Tooth Shade Material
16 Jan 2002	K013647	REVOLUTION FORMULA 2	Sybron Dental Specialties	EBF Resin Tooth Shade Material
29 Oct 2001	K013198	FUJI VII CAPSULE	GC America Inc.	EMA Dental Cement
10 Sep 2001	K012442	MODIFICATION TO CLEARFIL SE BOND	Kuraray Medical, Inc.	KLE Resin Tooth Bonding Agent
4 Sep 2001	K012432	MODIFICATION TO CLEARFIL PHOTO BOND	Kuraray Medical, Inc.	KLE Resin Tooth Bonding Agent
4 Jan 2001	K003658	TEMP-BOND NE 2	Sybron Dental Specialties	EMA Dental Cement
28 Sep 2000	K002452	3M RELY X VENEER CEMENT TRY-IN PASTER	3M Company	EMA Dental Cement
10 Aug 2000	K001655	PERMLASTIC 2	Sybron Dental Specialties	ELW Impression Material
17 Jul 2000	K001730	GC FUJICEM	GC America Inc.	EMA Dental Cement
5 Apr 2000	K000629	FLEXTIME	Heraeus Kulzer, LLC	ELW Impression Material
30 Mar 2000	K000591	DIMENSION PENTA H, DIMENSION PENTA H QUICK	Espe Dental AG	ELW Impression Material
27 Jan 2000	K994190	IMPREGUM GARANT L DUOSOFT	Espe Dental AG	ELW Impression Material
11 Jan 2000	K993973	FUJI II LC CAPSULE	GC America Inc.	EBF Resin Tooth Shade Material
13 Dec 1999	K993783	TETRIC FLOW	Ivoclar North America, Inc.	EBF Resin Tooth Shade Material
14 Oct 1999	K992985	GLUMA COMFORT BOND	Heraeus Kulzer, LLC	KLE Resin Tooth Bonding Agent
8 Oct 1999	K992326	3M CLINPRO SEALANT	3M Company	EBC Pit and Fissure Sealant and Conditioner
8 Sep 1999	K992897	IMPREGUM PENTA	Espe Dental AG	ELW Impression Material
8 Sep 1999	K992895	IMPREGUM F	Espe Dental AG	ELW Impression Material
9 Aug 1999	K991961	3M LVR SYSTEM	3M Company	EBF Resin Tooth Shade Material
8 Mar 1999	K990498	OPTIBOND SOLO PLUS	Sybron Dental Specialties	KLE Resin Tooth Bonding Agent
4 Feb 1999	K984505	MIRACLE MIX POWDER/LIQUID	GC America Inc.	EMA Dental Cement
13 Jan 1999	K984387	R-30 AESTHETIC RESTORATIVE	Dentsply Intl., Inc.	EBF Resin Tooth Shade Material
19 Oct 1998	K982695	GC RELINE	GC America Inc.	EBI Rebasing Repairing Relining Denture Resin
8 Oct 1998	K982590	TEMPBOND CLEAR-2	Sybron Dental Specialties	EMA Dental Cement
21 Sep 1998	K982394	PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM	Dentsply Intl., Inc.	KLE Resin Tooth Bonding Agent
8 Sep 1998	K982616	IPS EMPRESS 2	Ivoclar North America, Inc.	EIH Porcelain Powder
24 Aug 1998	K982461	GLASIONOMER CEMENT CX PLUS	Shofu Inc	EMA Dental Cement
9 Aug 1998	K981647	3M DENT II SYSTEM	3M Company	EBF Resin Tooth Shade Material
10 Jul 1998	K981965	FLOWABLE COMPOSITE	Dentsply Intl., Inc.	EMA Dental Cement

Showing the 120 most recent of 184.

Registered establishments

Establishment	Location	What it does
JERSEY DENTAL SUPPLIESFDA reg. 3012187973	Lakewood, NJ, United States	Repacker / relabeler, Reprocessor

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10050503). 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.