Product Code: LBH FDA class 2 21 CFR 872.3260

Varnish, Cavity

Dental

Cavity varnish is a dental material applied to the walls and floor of a prepared tooth cavity to seal dentinal tubules, reduce postoperative sensitivity, and protect pulp tissue before placement of a restoration. It is classified as FDA Class 2, indicating moderate risk and the need for 510(k) premarket notification. The product code is LBH, regulated under 21 CFR 872.3260, in the Dental specialty. Third-party review is available for this device.

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510(k)s

138

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LBH
Device Class: FDA class 2
Regulation Number: 872.3260
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 138 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253052	Fluoride Varnish (Type A,Type C)	Jun 11, 2026	Substantially Equivalent	Nagy Oral Technology Qinhuangdao Co., Ltd.
K252073	VOCO Profluorid Varnish + BioMin	May 01, 2026	Substantially Equivalent	Voco GmbH
K261404	UltraEZ	Apr 30, 2026	Substantially Equivalent	Ultradent Products, Inc.
K260830	APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)	Mar 18, 2026	Substantially Equivalent	Sangi Co., Ltd.
K250714	FluoroDose Varnish	Nov 21, 2025	Substantially Equivalent	Centrix, Inc.
K243777	Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum)	May 27, 2025	Substantially Equivalent	Theodent, LLC
K241489	ReminGel	Jan 08, 2025	Substantially Equivalent	Inter-Med, Inc.
K241568	CrystLCare PRO Biorestorative, Fluoride-Plus	Jan 02, 2025	Substantially Equivalent	GreenMark Biomedical, Inc.
K242913	Jasmate® Toothpaste	Nov 22, 2024	Substantially Equivalent	Jasberry Healthcare Private Limited
K233768	Papacarie Duo	Jul 18, 2024	Substantially Equivalent	Elevate Oral Care
K231060	ProMin Dental Desensitizing Gel	Jun 13, 2024	Substantially Equivalent	Belport Company, Inc., Gingi-Pak
K230333	Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)	Jul 24, 2023	Substantially Equivalent	Kettenbach GmbH & Co. KG
K222891	Dental Desensitizer	May 25, 2023	Substantially Equivalent	Guangzhou Beogene Biotech Co., Ltd.
K231338	3M Clinpro Clear 2.1% Sodium Fluoride Treatment	May 10, 2023	Substantially Equivalent	3M Espe Dental Products
K220419	Apapro Desensitizer	Feb 16, 2022	Substantially Equivalent	Sangi Co., Ltd.
K200077	BioMin Restore Plus	Nov 06, 2020	Substantially Equivalent	Dr. Collins, Inc.
K200614	FiteBac Antimicrobial Cavity Cleanser	Jun 25, 2020	Substantially Equivalent	Largent Health, LLC
K192381	DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor	Feb 18, 2020	Substantially Equivalent	Scientific Pharmaceuticals
K191453	Cervitec F	Feb 11, 2020	Substantially Equivalent	Ivoclar Vivadent, AG
K190271	FiteBac Cavity Cleanser	Jan 23, 2020	Substantially Equivalent	Largent Health, LLC
K182917	FluoroCal	Nov 18, 2019	Substantially Equivalent	Bisco, Inc.
K181965	Restore Toothpaste	Jun 13, 2019	Substantially Equivalent	Dr. Collins, Inc.
K160377	V-varnish Premium	Dec 02, 2016	Substantially Equivalent	Vericom Co., Ltd.
K153334	Oral-B 5% Sodium Fluoride Varnish	May 20, 2016	Substantially Equivalent	Young Dental Manufacturing Co. 1, LLC
K151302	Clinpro Varnish	Sep 18, 2015	Substantially Equivalent	3M Company
K143155	LISTERINE Sensitivity Defense Mouthrinse	Jan 29, 2015	Substantially Equivalent	Johnson & Johnson Healthcare Products, Division of Mcneil-Pp
K140350	VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL	Dec 12, 2014	Substantially Equivalent	Preventive Technologies, Inc.
K131487	FLUOR PROTECTOR S	Oct 08, 2014	Substantially Equivalent	Ivoclar Vivadent, AG
K141422	PROFLUORO FLUORIDE VARNISH	Sep 30, 2014	Substantially Equivalent	Pac-Dent International, Inc.
K140349	STARBRIGHT 5% SODIUM FLUORIDE VARNISH	Sep 22, 2014	Substantially Equivalent	Nanova Biomaterials, Inc.
K140481	COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH	Jun 05, 2014	Substantially Equivalent	Colgate-Palmolive Company
K132426	SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS	Feb 14, 2014	Substantially Equivalent	Sylphar N.V.
K132109	ENAMELAST	Nov 01, 2013	Substantially Equivalent	Ultradent Products Inc. / Oratech, LLC
K124025	ALPHA-PRO WHITE VARNISH	Sep 18, 2013	Substantially Equivalent	Dental Technologies, Inc.
K131376	SMARTCOAT 2.5% NAF VARNISH	Aug 27, 2013	Substantially Equivalent	Elevate Oral Care
K123653	SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)	Jun 03, 2013	Substantially Equivalent	Bisco, Inc.
K122908	PRG BARRIER COAT	Apr 26, 2013	Substantially Equivalent	Shofu Dental Corporation
K122708	REMESENSE FOR SENSITIVE TEETH	Jan 14, 2013	Substantially Equivalent	Sylphar N.V.
K122331	CAVITY VARNISH	Oct 15, 2012	Substantially Equivalent	Dentsply International, Inc.
K120176	SENZZZZZ AWAY	Jul 25, 2012	Substantially Equivalent	Centrix, Inc.
K120109	SUPER SEAL TOOTH DESENSITIZER	Mar 07, 2012	Substantially Equivalent	Phoenix Dental, Inc.
K113146	PCXX VARNISH	Jan 23, 2012	Substantially Equivalent	Ross Healthcare, Inc.
K112946	ACTIV VARNISH	Dec 09, 2011	Substantially Equivalent	Pulpdent Corporation
K103461	COLGATE DESENSITIZING DENTAL CREAM	Sep 13, 2011	Substantially Equivalent	Colgate-Palmolive Co.
K103160	NUPRO MODEL 13016901	Jan 06, 2011	Substantially Equivalent	CAO Group, Inc.
K102808	MI VARNISH	Dec 22, 2010	Substantially Equivalent	GC America, Inc.
K100172	TOKUYAMA SHIELD FORCE	Oct 21, 2010	Substantially Equivalent	Tokuyama Dental Corporation
K100540	ASCENT F-COAT MODEL: 006-00097	Sep 23, 2010	Substantially Equivalent	CAO Group, Inc.
K100503	PULPDENT COPAL VARNISH WITH FLUORIDE	May 12, 2010	Substantially Equivalent	Pulpdent Corporation
K093620	PULPDENT FLUORIDE VARNISH	Mar 10, 2010	Substantially Equivalent	Pulpdent Corporation
K092141	VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH	Mar 10, 2010	Substantially Equivalent	3M Espe Dental Products
K093575	GLUMA DESENSITIZER POWER GEL	Mar 05, 2010	Substantially Equivalent	Heraeus Kulzer, LLC
K090519	VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247	Apr 15, 2009	Substantially Equivalent	3M Company
K082594	REMESENSE	Mar 19, 2009	Substantially Equivalent	Remedent NV
K090597	FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH	Mar 16, 2009	Substantially Equivalent	Pascal Co., Inc.
K083036	VOCO PROFLUORID L	Jan 12, 2009	Substantially Equivalent	Voco GmbH
K082198	DURASHIELD PLUS	Oct 29, 2008	Substantially Equivalent	Dentsply Intl., Inc.
K082071	ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT	Oct 02, 2008	Substantially Equivalent	Adpharma, Inc.
K080814	VOCO PROFLUORID VARNISH	Jul 24, 2008	Substantially Equivalent	Voco GmbH
K080228	ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH	Mar 27, 2008	Substantially Equivalent	Novamin Technology, Inc.
K073061	THE PROXIVENT KIT	Feb 29, 2008	Substantially Equivalent	Coll Partners , Ltd.
K080249	FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505	Feb 08, 2008	Substantially Equivalent	Ultradent Products, Inc.
K073117	DENTIN DESENSITIZER AGENT	Dec 19, 2007	Substantially Equivalent	Dentsply Intl., Inc.
K072342	SULTAN TOOTH ROOT DESENSITIZER	Oct 03, 2007	Substantially Equivalent	Dentsply International, Inc.
K072338	CERVITEC PLUS	Sep 21, 2007	Substantially Equivalent	Ivoclar Vivadent, Inc.
K061438	ULTRAEZ DESENSITIZING GEL	Jun 12, 2007	Substantially Equivalent	Ultradent Products, Inc.
K070070	ASCENT DENTAL CLEANSER	May 25, 2007	Substantially Equivalent	CAO Group, Inc.
K071267	PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN	May 18, 2007	Substantially Equivalent	Novamin Technology, Inc.
K070289	ACQUASEAL BENZ	May 04, 2007	Substantially Equivalent	Acquamed Technologies, Inc.
K062176	RELIEF ACP ORAL CARE GEL	Jan 10, 2007	Substantially Equivalent	Discus Dental, Inc.
K062683	ENAMEL PRO VARNISH	Nov 21, 2006	Substantially Equivalent	Premier Dental Products Co.
K061359	DENSHIELD TREATMENT FOR SENSITIVE TEETH	Oct 18, 2006	Substantially Equivalent	Novamin Technology, Inc.
K052263	MULTIPLE (TOOTH DESENSITIZER)	Dec 16, 2005	Substantially Equivalent	Cosmedent, Inc.
K051750	FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502	Sep 19, 2005	Substantially Equivalent	Ultradent Products, Inc.
K050486	PROTECT TOOTH DESENSITIZER	Jun 07, 2005	Substantially Equivalent	Sunstar Butler
K040858	ORALIEF THERAPY FOR SENSITIVE TEETH	Sep 02, 2004	Substantially Equivalent	Novamin Technology, Inc.
K040473	ORAVIVE TOOTH REVITALIZING PASTE	Mar 10, 2004	Substantially Equivalent	Novamin Technology, Inc.
K040098	VARNISHAMERICA	Feb 04, 2004	Substantially Equivalent	Medical Products Laboratories, Inc.
K033295	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	Oct 28, 2003	Substantially Equivalent	Novamin Technology, Inc.
K030922	VIVASENS	Oct 17, 2003	Substantially Equivalent	Ivoclar Vivadent, Inc.
K031932	FLUORIDE VARNISH	Sep 15, 2003	Substantially Equivalent	Dentsply Intl.
K030488	FLUORILAQ	May 02, 2003	Substantially Equivalent	Pascal Co., Inc.
K023671	AQUEOUS ACRYLIC DISPERSION 28% W/W	Nov 25, 2002	Substantially Equivalent	Chx Technologies, Inc.
K021131	CHLORAPREP	Sep 26, 2002	Substantially Equivalent	Centrix, Inc.
K021805	SEAL & PROTECT PROTECTIVE SEALANT	Aug 19, 2002	Substantially Equivalent	Dentsply Intl.
K013411	PULPDENT CAVITY PREPARATION IV	Dec 12, 2001	Substantially Equivalent	Pulpdent Corp.
K010957	QUELL DESENSITIZER	Jun 25, 2001	Substantially Equivalent	Jeneric/Pentron, Inc.
K010255	CAVITY VARNISH	Apr 20, 2001	Substantially Equivalent	Rite-Dent Manufacturing Corp.
K003482	PROCLUDE-SENSITIVE	Feb 01, 2001	Substantially Equivalent	Ortek Therapeutics, Inc.
K002581	DURAGARD SODIUM FLUORIDE VARNISH	Oct 20, 2000	Substantially Equivalent	Sultan Dental Products, Ltd.
K994180	PULPDENT CAVITY PREPARATION III	Mar 02, 2000	Substantially Equivalent	Pulpdent Corp.
K994181	PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE	Feb 29, 2000	Substantially Equivalent	Pulpdent Corp.
K994182	PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE	Feb 23, 2000	Substantially Equivalent	Pulpdent Corp.
K992822	SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE	Nov 17, 1999	Substantially Equivalent	Dentsply Intl.
K990779	HEMASEAL & CIDE	Nov 17, 1999	Substantially Equivalent	Advantage Dental Products, Inc.
K992629	D/SENSE II (GREEN-OR) DENTIN DESENSITIZER	Oct 22, 1999	Substantially Equivalent	Centrix, Inc.
K982915	SCI-PHARM DFV VARNISH	Feb 12, 1999	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K983305	SCI-PHARM DESENSITIZING VARNISH	Dec 17, 1998	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K981972	GREEN-OR DENTIN DESENSITIZER	Dec 07, 1998	Substantially Equivalent	Centrix, Inc.
K974202	PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS	Mar 19, 1998	Substantially Equivalent	Pulpdent Corp.
K974398	PULPDENT CAVITY VARNISH	Feb 18, 1998	Substantially Equivalent	Pulpdent Corp.
K973919	CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)	Dec 16, 1997	Substantially Equivalent	Medental Intl.
K963979	ULTRADENT UNIVERSAL DENTIN SEALANT	Dec 12, 1996	Substantially Equivalent	Ultradent Products, Inc.
K961893	DURAFLOR	Aug 14, 1996	Substantially Equivalent	Pharmascience, Inc.
K955521	ALPHA-DENT COPAL CAVITY VARNISH	Jan 24, 1996	Substantially Equivalent	Wallace A. Erickson & Co.
K953168	ULTRACID F DISINFECTING SOLUTION	Sep 08, 1995	Substantially Equivalent	Ultradent Products, Inc.
K953167	ULTRACID DISINFECTING SOLOUTION	Sep 08, 1995	Substantially Equivalent	Ultradent Products, Inc.
K945794	DURAPHAT	Jul 26, 1995	Substantially Equivalent	Inpharma
K946032	FLUOR PROTECTOR	Mar 07, 1995	Substantially Equivalent	Ivoclar North America, Inc.
K944934	POLYURETHANE SOLUTION 29% W/W	Dec 09, 1994	Substantially Equivalent	Knowell Therapeutic Technologies,Inc.
K933505	BOSWORTH COPALIONER	Jan 07, 1994	Substantially Equivalent	Harry J. Bosworth Co.
K925375	CONSEPSIS SCRUB	Jul 22, 1993	Substantially Equivalent	Ultradent Products, Inc.
K924982	CONSEPSIS(TM)	Jul 08, 1993	Substantially Equivalent	Ultradent Products, Inc.
K931096	DURAFLOR	May 27, 1993	Substantially Equivalent	Pharmascience, Inc.
K924827	MICRODOSE POTASSIUM OXYLATE	Mar 05, 1993	Substantially Equivalent	Unicep
K901915	DENTIN PROTECTOR	Jun 27, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K901049	COPAL VARNISH	May 29, 1990	Substantially Equivalent	Pulpdent Corp.
K900946	UNIVERSUM	May 25, 1990	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K880741	ESPE VARNISH	Jul 01, 1988	Substantially Equivalent	Espe GmbH (Us)
K881026	CONTAC, A DENTIN SEALANT	Jun 01, 1988	Substantially Equivalent	Harry J. Bosworth Co.
K864051	TUBULICID RED LABEL	Dec 10, 1986	Substantially Equivalent	Dental Dimensions Supply Co.
K864052	TUBULITEC PRIMER	Dec 05, 1986	Substantially Equivalent	Dental Dimensions Supply Co.
K864050	TUBULICID BLUE LABEL	Dec 05, 1986	Substantially Equivalent	Dental Dimensions Supply Co.
K860633	FLUOROSEAL, DENTIN SEALER AND CAVITY LINER	Apr 11, 1986	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K852755	UNIVAR UNIVERSAL DENTIN VARNISH	Sep 23, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K852756	TELEDYNE GETZ BARRIER-DENTIN SEALER	Jul 31, 1985	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K851052	TUBULITEC PRIMER	Jul 31, 1985	Substantially Equivalent	Dental Therapeutics AB
K851030	TEMREX-DENTIN VARNISH	Jun 20, 1985	Substantially Equivalent	Temrex Corp.
K833701	ACA THYROXINE ANALYTICAL TEST PACK	Jan 13, 1984	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K832497	CAVITY CLEANSER	Oct 04, 1983	Substantially Equivalent	Den-Mat Corp.
K812550	BEAUCAV	Sep 25, 1981	Substantially Equivalent	Sci-Pharm, Inc.
K812548	COBEAU	Sep 25, 1981	Substantially Equivalent	Sci-Pharm, Inc.
K810913	CAVITY VARNISH	Sep 21, 1981	Substantially Equivalent	Dentsply Intl.
K802926	SCI-PHARM UNIVERSAL CAVITY VARNISH	Dec 19, 1980	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K801047	PLY LESIVE	May 20, 1980	Substantially Equivalent	May-Pell Chemical Development Co.
K800438	DENTAL CAVITY VARNISH, CONCENTRATED	Mar 12, 1980	Substantially Equivalent	Scientific Pharmaceuticals, Inc.
K760982	DENTAL VARNISH	Nov 15, 1976	Substantially Equivalent	Adp Intl., Inc.
K760660	HYDROL	Sep 27, 1976	Substantially Equivalent	Septodont, Inc.