Data / Medical devices / United States / Jersey Dental Supplies

Jersey Dental Supplies: FDA-registered device maker in Lakewood, NJ, United States, 195 510(k) clearances and 1 PMA approval

Name: Jersey Dental Supplies FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jersey Dental Supplies is registered with the FDA (registration 3012187973) in Lakewood, NJ, United States. It lists 52 device types. The FDA files 195 510(k) clearances and 1 PMA approval under its listings, the newest dated April 10, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012187973
Address: 1095 Towbin Ave, Lakewood, NJ, United States, 08701
Owner or operator: Jersey Dental Supplies (10050503)
Roles: Repackager or relabeler, Reprocessor
First device listed: July 21, 2016
Registered through: 2026
Brand names listed: 3 Dynamic TiBase, 3M CLINPRO SEALANT, 3M DENT II SYSTEM, 3M DENT SYSTEM, 3M LVR SYSTEM, 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95, 3M Protemp Cement Temporary Dental Cement, 3M RESIN CEMENT and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Repackager or relabeler	accessdata.fda.gov
Activator, Ultraviolet, For Polymerization	EBZ	2	Repackager or relabeler	accessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, Resin	DYH	2	Repackager or relabeler	accessdata.fda.gov
Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&)	KOQ	1	Repackager or relabeler	accessdata.fda.gov
Agent, Absorbable Hemostatic, Collagen Based	LMF	3	Repackager or relabeler	accessdata.fda.gov
Agent, Polishing, Abrasive, Oral Cavity	EJR	1	Repackager or relabeler	accessdata.fda.gov
Agent, Tooth Bonding, Resin	KLE	2	Repackager or relabeler	accessdata.fda.gov
Alloy, Amalgam	EJJ	2	Repackager or relabeler	accessdata.fda.gov
Applicator, Resin	KXR	1	Repackager or relabeler	accessdata.fda.gov
Bandage, Liquid	KMF	1	Repackager or relabeler	accessdata.fda.gov
Capsule, Dental, Amalgam	DZS	1	Repackager or relabeler	accessdata.fda.gov
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	2	Repackager or relabeler	accessdata.fda.gov
Cement, Dental	EMA	2	Repackager or relabeler, Reprocessor	accessdata.fda.gov
Cleanser, Root Canal	KJJ	U	Repackager or relabeler	accessdata.fda.gov
Coating, Filling Material, Resin	EBD	2	Repackager or relabeler	accessdata.fda.gov
Cord, Retraction	MVL	U	Repackager or relabeler	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Crown, Preformed	ELZ	1	Repackager or relabeler	accessdata.fda.gov
Dental Amalgam	OIV	2	Repackager or relabeler	accessdata.fda.gov
Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief	MZW	2	Repackager or relabeler	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Repackager or relabeler	accessdata.fda.gov
Disk, Abrasive	EHJ	1	Repackager or relabeler	accessdata.fda.gov
Film, Radiographic	IWZ	1	Repackager or relabeler	accessdata.fda.gov
Floss, Dental	JES	1	Repackager or relabeler	accessdata.fda.gov
Handpiece, Air-Powered, Dental	EFB	1	Repackager or relabeler	accessdata.fda.gov
Implant, Endosseous, Root-Form	DZE	2	Repackager or relabeler	accessdata.fda.gov
Instruments, Dental Hand	DZN	1	Repackager or relabeler	accessdata.fda.gov
Liner, Cavity, Calcium Hydroxide	EJK	2	Repackager or relabeler	accessdata.fda.gov
Mask, Oxygen	BYG	1	Repackager or relabeler	accessdata.fda.gov
Mask, Surgical	FXX	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression	ELW	2	Repackager or relabeler	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Repackager or relabeler	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Repackager or relabeler	accessdata.fda.gov
Mercury	ELY	2	Repackager or relabeler	accessdata.fda.gov
Point, Abrasive	EHL	1	Repackager or relabeler	accessdata.fda.gov
Post, Root Canal	ELR	1	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Repackager or relabeler	accessdata.fda.gov
Preparer, Root Canal Endodontic	EKQ	1	Repackager or relabeler	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Repackager or relabeler	accessdata.fda.gov
Resin, Root Canal Filling	KIF	2	Repackager or relabeler	accessdata.fda.gov
Retainer, Matrix	JEP	1	Repackager or relabeler	accessdata.fda.gov
Retractor, All Types	EIG	1	Repackager or relabeler	accessdata.fda.gov
Scaler, Ultrasonic	ELC	2	Repackager or relabeler	accessdata.fda.gov
Sealant, Pit And Fissure, And Conditioner	EBC	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Syringe, Restorative And Impression Material	EID	1	Repackager or relabeler	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Repackager or relabeler	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Repackager or relabeler	accessdata.fda.gov
Varnish, Cavity	LBH	2	Repackager or relabeler	accessdata.fda.gov
Zinc Oxide Eugenol	EMB	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 195.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 10, 2026	K252506	BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
July 3, 2025	K243207	BD Vacutainer® Eclipse Blood Collection Needle	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
April 1, 2020	K200188	DSI Dental Implant System	DZE	Substantially Equivalent	Dsi Dental Solutions, Ltd.	accessdata.fda.gov
March 20, 2019	K183399	BD Nexiva Closed IV Catheter System	FOZ	Substantially Equivalent	Becton Dickinson Infusion Therapy Systems, Inc.	accessdata.fda.gov
August 29, 2018	K180802	Meta P&Bond	KLE	Substantially Equivalent	Meta Biomed Co., Ltd.	accessdata.fda.gov
August 22, 2018	K181312	GrandioSO x-tra	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
May 4, 2018	K162021	3.0 Dynamic TiBase	NHA	Substantially Equivalent	Talladium Espana, SL	accessdata.fda.gov
March 8, 2018	K173500	NMF004A	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 29, 2017	K170896	Admira Fusion x-base	EBF	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
February 6, 2017	K170330	3M Protemp Cement Temporary Dental Cement	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
July 27, 2016	K153067	Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
July 12, 2016	K153325	Gradia Plus	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 6, 2016	K152956	Pulp Canal Sealer, Pulp Canal Sealer EWT	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
April 14, 2016	K152959	Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes	KIF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
March 4, 2016	K152861	Aquasil Ultra + Smart Wetting Impression Material	ELW	Substantially Equivalent	Dentply International, Inc.	accessdata.fda.gov
December 9, 2015	K152243	One Coat 7 Universal	KLE	Substantially Equivalent	Coltene/Whaledent AG	accessdata.fda.gov
April 20, 2015	K143140	G-Premio BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
November 25, 2014	K142389	Variolink Esthetic	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
October 8, 2014	K131487	FLUOR PROTECTOR S	LBH	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
August 1, 2014	K141610	FUTURABOND M+	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
May 8, 2014	K141081	FILTEK BULK FILL POSTERIOR RESTROATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
April 29, 2014	K140125	NEW STETIC DENTAL AMALGAM ALLOY	OIV	Substantially Equivalent	New Stetic	accessdata.fda.gov
March 14, 2014	K133824	CERASMART	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 11, 2014	K133318	ADHESE UNIVERSAL	KLE	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
May 30, 2013	K130869	TAKE 1 ADVANCE	ELW	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
February 19, 2013	K123595	NEXUS RMGI	EMA	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
February 5, 2013	K123215	VISCOSTAT CLEAR	MVL	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
January 31, 2013	K123397	MULTILINK AUTOMIX	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
December 13, 2012	K122269	ENAMIC	EIH	Substantially Equivalent	Vita Zahnfabrik H.Rauter GmbH & Co.	accessdata.fda.gov
December 7, 2012	K123278	IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF	KLE	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
August 29, 2012	K121230	IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE	EBF	Substantially Equivalent	Ivoclar Vivadent, AG	accessdata.fda.gov
March 19, 2012	K120453	FILTEK BULK FILL FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Espe Dental Products	accessdata.fda.gov
October 14, 2011	K111980	CLEARFIL TRI-S BOND PLUS	KLE	Substantially Equivalent	Kuraray America, Inc.	accessdata.fda.gov
October 14, 2011	K111958	TETRIC EVOCERAM BULK FILL	EBF	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
September 23, 2011	K112517	ULTRASEAL XT HYDRO	EBC	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
September 16, 2011	K111782	BEAUTISEALANT	EBC	Substantially Equivalent	Shofu Dental Corporation	accessdata.fda.gov
August 29, 2011	K110756	BLUEPHASE STYLE	EBZ	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
June 3, 2011	K110508	SUGLUE-10	EMA	Substantially Equivalent	3M Espe AG	accessdata.fda.gov
May 19, 2011	K110302	ADHESIVE EXL-759	KLE	Substantially Equivalent	3M Espe AG	accessdata.fda.gov
April 28, 2011	K110582	VALO CORDLESS	EBZ	Substantially Equivalent	Ultradent Products, Inc.	accessdata.fda.gov
April 5, 2011	K110378	IMPRESSION COMPOUND	ELW	Substantially Equivalent	Spofadental	accessdata.fda.gov
February 14, 2011	K103379	TELIO CS INLAY & TELIO CS ONLAY	EBG	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
January 20, 2011	K103351	DMC COMPOSITE 2	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
August 23, 2010	K101603	BEAUTIFIL FLOW PLUS	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
June 22, 2010	K100908	UNICEM HM	EMA	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
May 12, 2010	K100235	FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
February 19, 2010	K093721	COSP2	MVL	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
January 27, 2010	K093484	PREMISE FLOWABLE MODIFIED	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
September 3, 2009	K091635	VENUS DIAMOND FLOW	EBF	Substantially Equivalent	Heraeus Kulzer, LLC	accessdata.fda.gov
July 22, 2009	K091388	GCUC-505	EBF	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 17, 2009	K091106	EQUIA	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 4, 2009	K091019	SPEEDCEM	EMA	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
May 28, 2009	K090458	DEXIS SENSOR	MUH	Substantially Equivalent	Dexis, LLC	accessdata.fda.gov
May 21, 2009	K091023	METAMORPHOSIS	EBF	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
May 11, 2009	K090826	MONOBOND PLUS	KLE	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
December 17, 2008	K083610	FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE	EBF	Substantially Equivalent	3M Company	accessdata.fda.gov
December 11, 2008	K082744	BEAUTIBOND	KLE	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
December 11, 2008	K082671	HERCULITE ULTRA	EBF	Substantially Equivalent	Sybron Dental Specialties	accessdata.fda.gov
July 24, 2008	K080814	VOCO PROFLUORID VARNISH	LBH	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
June 23, 2008	K081664	NOMAD PRO X-RAY SYSTEM	EHD	Substantially Equivalent	Aribex, Inc.	accessdata.fda.gov
April 7, 2008	K080305	NEXCOMP AND META ETCHANT	EBF	Substantially Equivalent	Meta Biomed Co., Ltd.	accessdata.fda.gov
March 26, 2008	K080514	PECD-01 AND PECD QUICK-01	ELW	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
January 29, 2008	K073209	MAXCEM 2	MZW	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
January 23, 2008	K073173	SELF-ADHESIVE RESIN CEMENT	EMA	Substantially Equivalent	Dentsply Interntional	accessdata.fda.gov
January 9, 2008	K073296	TEMPXN28	EBG	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
August 15, 2007	K071742	BEAUTIFIL II	EBF	Substantially Equivalent	Shofu Dental Corp.	accessdata.fda.gov
June 7, 2007	K070723	FUTURABOND DC/SINGLE DOSE	KLE	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 12, 2007	K070854	GC MI PASTE PLUS	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070698	COE COMFORT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
March 29, 2007	K070697	COE SOFT	EBI	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
February 26, 2007	K070319	GC FUJI IX GP EXTRA	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 19, 2006	K062519	NEXUS 3	EMA	Substantially Equivalent	Kerr Corporation	accessdata.fda.gov
July 14, 2006	K061535	GC XLC-100 CAPSULE	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
May 2, 2006	K060894	BIFIX QM	EMA	Substantially Equivalent	Voco GmbH	accessdata.fda.gov
April 24, 2006	K060684	ADPER PROMPT, ADPER PROMPT L-POP	KLE	Substantially Equivalent	3M Espe AG Dental Products	accessdata.fda.gov
March 28, 2006	K060469	OPTIBOND ALL-IN-ONE	KLE	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
February 3, 2006	K053565	TEMPBOND CLEAR WITH TRICLOSAN	EMA	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
October 14, 2005	K051705	IPS E.MAX CAD/IPS E.MAX ZIRCAD	EIH	Substantially Equivalent	Ivoclar Vivadent, Inc.	accessdata.fda.gov
September 27, 2005	K052235	LCR	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
July 15, 2005	K051424	HYDROGUM 5	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
May 12, 2005	K050600	MINILOC SAFETY INFUSION SET	FPA	Substantially Equivalent	Specialized Health Products, Intl.	accessdata.fda.gov
April 15, 2005	K050604	KERR VPS IMPRESSION MATERIAL	ELW	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
December 15, 2004	K043131	TORPICALGIN	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
December 7, 2004	K042452	RIVA SILVER	EMA	Substantially Equivalent	Southern Dental Industries, Inc.	accessdata.fda.gov
November 24, 2004	K042769	ADSEAL ROOT CANAL SEALER	KIF	Substantially Equivalent	Meta Biomed Co., Ltd.	accessdata.fda.gov
October 20, 2004	K042200	MI PASTE	EJR	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
October 18, 2004	K041272	DYRACT CEM PLUS CEMENT	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
June 29, 2004	K041471	G-BOND	KLE	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
June 16, 2004	K040906	CALIBRA CEMENT	EMA	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
October 8, 2003	K032605	METAPASTE CALCIUM HYDROXIDE WITH BARIUM SULFATE TEMPORARY ROOT CANAL FILLING	KIF	Substantially Equivalent	Meta Biomed Co., Ltd.	accessdata.fda.gov
October 7, 2003	K032603	METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING	KIF	Substantially Equivalent	Meta Biomed Co., Ltd.	accessdata.fda.gov
May 8, 2003	K030573	BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341	JKA	Substantially Equivalent	Bd Vacutainer Systems Preanalyical Solutions	accessdata.fda.gov
December 18, 2002	K024041	ZETAPLUS SOFT	ELW	Substantially Equivalent	Zhermack S.P.A.	accessdata.fda.gov
August 2, 2002	K022476	RELYX RMGIP	EMA	Substantially Equivalent	3M Company	accessdata.fda.gov
June 26, 2002	K012308	KAVO QUATTROCARE	EFB	Substantially Equivalent	Kavo America	accessdata.fda.gov
May 13, 2002	K021416	AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
May 10, 2002	K021413	AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL	ELW	Substantially Equivalent	Dentsply Intl.	accessdata.fda.gov
February 28, 2002	K020117	GC FUJI LINING LC PASTE PAK	EMA	Substantially Equivalent	GC America, Inc.	accessdata.fda.gov
January 18, 2002	K013510	POINT 4 MODIFIED	EBF	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov
January 16, 2002	K013647	REVOLUTION FORMULA 2	EBF	Substantially Equivalent	Sybron Dental Specialties, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
September 30, 1999	P990004	SURGIFOAM ABSORBABLE GELATIN SPONGE, USP	LMF	79	September 18, 2026	accessdata.fda.gov

Compare with other makers

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.