Dental Device Guide
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Prosthetic devices · 21 CFR 872 Subpart D

Cavity Varnish

FDA device type “Varnish, Cavity”.

FDA codeLBHClass221 CFR872.3260Pathway510(k)CategorySealants & varnishes
Companies listing it
7448 makers
Brands and models
149
510(k) clearances
14017 in five years
FDA name
Varnish, Cavity
1976: 21980: 31981: 31983: 11984: 11985: 41986: 41988: 21990: 31993: 41994: 21995: 41996: 31997: 11998: 41999: 42000: 42001: 42002: 32003: 42004: 32005: 32006: 22007: 82008: 62009: 42010: 72011: 32012: 42013: 62014: 62015: 22016: 22019: 22020: 52022: 12023: 32024: 32025: 42026: 619801990200020102020

510(k) clearances per year, 1976–2026

Companies that list LBH

74 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMakerDentin Desensitizer Agent1482026
Mediclus Co., LtdSouth KoreaMakerAny-Com Kit · Any-Com Universal Kit · Hi-Bond Universal152026
Voco GmbHGermanyMakerVOCO Profluorid L · VOCO Profluorid Varnish · VOCO Profluorid Varnish + BioMin1172026
Shofu IncJapanMakerPRG BARRIER COAT962025
GC America Inc.United StatesMakerG-aenial Injection Matrix Kit · G-aenial Universal Flo · GC Fuji Triage EP · MI Fil · +11372026
Ultradent Products, Inc.United StatesMakerConsepsis · Consepsis Scrub · Consepsis V · Consumer Opalescence Sensitivity Relief · +4952026
Kulzer, LLCUnited StatesMakerGluma Comfort Bond + Desensitizer · iBond Total Etch · Venus Bulk Flow One · Venus Diamond · +2372026
Ivoclar Vivadent, AGUnited StatesMakerAdhese 100 · Adhese Universal · Adhese Universal DC · Adhese Universal kit VivaPen · +6942026
Kuraray Noritake Dental, Inc.JapanMakerCLEARFIL SE Protect · CLEARFIL Universal Bond · CLEARFIL Universal Bond Kit · KATANA Cleaner322025
Inter-Med, Inc.United StatesMakerReminGel72026
Premier Dental Products CompanyUnited StatesMakerBond-PR · ENAMEL PRO VARNISH · TastyTooth Varnish282026
Young Innovations IncUnited StatesMakerD-Lish 5% Sodium Fluoride Varnish - Assorted · D-Lish 5% Sodium Fluoride Varnish - Fresh Melon · D-Lish 5% Sodium Fluoride Varnish - Green Apple · D-Lish 5% Sodium Fluoride Varnish - Spearmint Surprise · +6232025
Kettenbach GmbH & Co. KGGermanyMakerProfisil · Profisil Free142026
Sdi LimitedAustraliaMakerAdhesive 1 · FROG · Go · Riva Star82022
Bisco, Inc.United StatesMaker—882025
Centrix, Inc.United StatesMakerD/Sense Crystal · FluoroDose442025
Vericom Co., Ltd.South KoreaMaker—202026
Den-Mat Holdings, LLCUnited StatesMakerFluoridex Varnish · G-BLOCK · G582026
Pac-Dent Inc.United StatesMakerPromin Dental Desensitizing Gel · 341101 ProMin Tooth Desensitizing Paste Tube Kit, 25g/tube, 2 tubes/box, 10 box/case · 341102 ProMin F Tooth Desensitizing Paste with Fluoride Tube Kit, 25g/tube, 2 tubes/box, 10 box/case · 341103 ProMin F Tooth Desensitizing Paste with Fluoride Pen, 4.5 ml52022
Elevate Oral CareUnited StatesMakerFluoriMax · PapaCarie Duo32024
Keystone IndustriesUnited StatesMakerCopaliner22025
Pulpdent CorporationUnited StatesMakerCopal Varnish · Embrace Varnish · Fluoride Varnish · Glass Ionomer Varnish1072021
Scientific PharmaceuticalsUnited StatesMakerBarrier · Fluoroseal · Sci-Pharm Copal · Sci-Pharm DFV · +2732020
Tokuyama Dental CorporationJapanMakerTOKUYAMA SHIELD FORCE · TOKUYAMA SHIELD FORCE PLUS192021
Philips Medical Systems International BVNetherlandsMakerRelief ACP Oral Care Gel162010
CAO Group, Inc.United StatesMakerBlissBond · BlissEtch · LEAP Cavity Cleansing Solution132020
Colgate-Palmolive CompanyUnited StatesMakerTom's of Maine Hydroxyapatite Gentle Mint · Tom's of Maine Sensitive + Rapid Relief Toothpaste · Tom's of Maine Sensitive + Whitening Toothpaste62014
Nanova Biomaterials IncUnited StatesMakerNovaBright 5% NaF Varnish · StarBright 5% NaF Varnish52018
Preventive Technologies, Inc.United StatesMakerVELLA 5% Sodium Fluoride Varnish with NUFLUOR and XYLITOL32014
Advantage Dental Products, Inc.United StatesMakerHemaseal & Cide · Hemaseal & Cide Unidose31999
Dental Technologies, Inc.United StatesMakerAlpha-Dent Cavity Varnish & Sealant · Alpha-Pro White Varnish22013
Temrex Corp.United StatesMakerCOPALITE22012
Medical Products Laboratories, Inc.United StatesMaker—22004
Chx Technologies, Inc.CanadaMakerPREVORA STAGE 212002
B.J.M. Laboratories LtdIsraelMakerBond-PR Universal Adhesive · UNI-Q-Bond Universal Bonding Agent——
Pascal InternationalUnited StatesMakerFluorilaq · Fluorilaq Squeeze · Fluorilaq Unit Dose——
Identa Dental Material GmbHGermanyMakerIDENTA Fluoride-containing Desensitizing Varnish——
Solventum US LLCUnited StatesMaker———
Cordica Medical (Formally Team Technologies, Inc)United StatesMaker———
medmix Deutschland GmbHGermanyMakerIBOND TOTAL ETCH——
O&S Dental IncUnited StatesMaker———
ConamcoUnited StatesMakerMedental——
Cetylite Industries, Inc.United StatesMakerVarnal · Zarosen——
F & A laboratorio Farmaceutico LtdaBrazilMakerPapaCarie Duo——
Voyant Beauty IncCanadaMakerLISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH MOUTHWASH · LISTERINE SENSITIVITY ZERO ALCOHOL MOUTH RINSE——
Cumberland Biotherapeutics, LLC.United StatesMakerDentoClude F——
Kenvue Brands LLCUnited StatesMakerListerine——
Silgan UnicepUnited StatesMakerTherma-Trol——
Cosmedent, Inc.United StatesRepacker / relabelerDesensitizer272024
NuSmile, Ltd.United StatesManufacturerNuSmile NuNamel Varnish22026
Medental Intl.United StatesRepacker / relabelerMedental71999
Dharma Research, Inc.United StatesContract manufacturerADS Fluoride Varnish · Citrine Fluoride Varnish · Sherbet Fluoride Varnish12015
DMG America, L.L.C.United StatesContract manufacturerVarnish, Cavity - Kolorz12013
Jersey Dental SuppliesUnited StatesRepacker / relabelerADHESE UNIVERSAL · G-aenial · Varnish, Cavity · Venus Diamond Flow · +1——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerdental varnish · tooth bond · Universal Flow · Varnish——
Patterson Companies, Inc.United StatesForeign exporterBraval Sodium Fluoride Varnish · G-aenial Injection Matrix Kit; G-aenial Universal Flo; MI Fil——
Soher Med LimitedHong Kong SAR ChinaForeign exporterdental bond · dental bonding · Flow · Tooth bond · +1——
SPS/Crosstex InternationalUnited StatesManufacturerSparkle V Varnish——
CARGUS International Inc.United StatesRepacker / relabeler———
AMD Medicom IncCanadaForeign exporterMedicom Duraflor Halo Varnish · Medicom Duraflor Varnish——
Viarden Lab LLCUnited StatesManufacturer for exportC-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTEC——
Dentonics IncUnited StatesRepacker / relabelerMaster-Dent——
NU Radiance, Inc.United StatesRepacker / relabelerNu Shield——
Sanicure BVNetherlandsForeign exporter———
Zapalign LLCUnited StatesRepacker / relabeler———
Summit Packaging Solutions LLCUnited StatesRepacker / relabelercavity Varnish——
HEXA DentalUnited StatesContract manufacturer———
Menasha Packaging Co. LLCUnited StatesRepacker / relabelerVarnish, Cavity——
Oral BiotechUnited StatesRepacker / relabelerCariFree Fluoride Varnish——
3D Dental Designs and Development LLCUnited StatesContract manufacturer———
The Atlanta Dental supply CompanyUnited StatesRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Zircon Plus LimitedIsraelForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
27 Oct 2026K262775AquaVance Clear Fluoride TreatmentThe Belport Company, Inc. DBA Gingi-Pak
3 Sep 2026K262243Profisil FreeKettenbach GmbH & Co. KG
11 Jun 2026K253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.
1 May 2026K252073VOCO Profluorid Varnish + BioMinVoco GmbH
30 Apr 2026K261404UltraEZUltradent Products, Inc.
18 Mar 2026K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.
21 Nov 2025K250714FluoroDose VarnishCentrix, Inc.
27 May 2025K243777Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)Theodent, LLC
8 Jan 2025K241489ReminGelInter-Med, Inc.
2 Jan 2025K241568CrystLCare™ PRO Biorestorative, Fluoride-PlusGreenMark Biomedical Inc.
22 Nov 2024K242913Jasmate® ToothpasteJasberry Healthcare Private Limited
18 Jul 2024K233768Papacarie DuoElevate Oral Care
13 Jun 2024K231060ProMin Dental Desensitizing GelBelport Company, Inc., Gingi-Pak
24 Jul 2023K230333Profisil 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)Kettenbach GmbH & Co. KG
25 May 2023K222891Dental DesensitizerGuangzhou Beogene Biotech Co., Ltd.
10 May 2023K2313383M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment3M Espe Dental Products
16 Feb 2022K220419Apapro DesensitizerSangi Co., Ltd.
6 Nov 2020K200077BioMin Restore PlusDr. Collins, Inc.
25 Jun 2020K200614FiteBac Antimicrobial Cavity CleanserLargent Health, LLC
18 Feb 2020K192381DFV 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 FlavorScientific Pharmaceuticals
11 Feb 2020K191453Cervitec FIvoclar Vivadent, AG
23 Jan 2020K190271FiteBac Cavity CleanserLargent Health, LLC
18 Nov 2019K182917FluoroCalBisco, Inc.
13 Jun 2019K181965Restore ToothpasteDr. Collins, Inc.
2 Dec 2016K160377V-varnish PremiumVericom Co., Ltd.
20 May 2016K153334Oral-B 5% Sodium Fluoride VarnishYoung Innovations Inc
18 Sep 2015K151302Clinpro Varnish3M Company
29 Jan 2015K143155LISTERINE Sensitivity Defense MouthrinseJohnson & Johnson Healthcare Products, Division of Mcneil-Pp
12 Dec 2014K140350VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOLPreventive Technologies, Inc.
8 Oct 2014K131487FLUOR PROTECTOR SIvoclar Vivadent, AG
30 Sep 2014K141422PROFLUORO FLUORIDE VARNISHPac-Dent International, Inc.
22 Sep 2014K140349STARBRIGHT 5% SODIUM FLUORIDE VARNISHNanova Biomaterials Inc
5 Jun 2014K140481COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASHColgate-Palmolive Company
14 Feb 2014K132426SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPSSylphar N.V.
1 Nov 2013K132109ENAMELASTUltradent Products Inc. / Oratech, LLC
18 Sep 2013K124025ALPHA-PRO WHITE VARNISHDental Technologies, Inc.
27 Aug 2013K131376SMARTCOAT 2.5% NAF VARNISHElevate Oral Care
3 Jun 2013K123653SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)Bisco, Inc.
26 Apr 2013K122908PRG BARRIER COATShofu Inc
14 Jan 2013K122708REMESENSE FOR SENSITIVE TEETHSylphar N.V.
15 Oct 2012K122331CAVITY VARNISHDentsply International, Inc.
25 Jul 2012K120176SENZZZZZ AWAYCentrix, Inc.
7 Mar 2012K120109SUPER SEAL TOOTH DESENSITIZERPhoenix Dental, Inc.
23 Jan 2012K113146PCXX VARNISHRoss Healthcare, Inc.
9 Dec 2011K112946ACTIV VARNISHPulpdent Corporation
13 Sep 2011K103461COLGATE DESENSITIZING DENTAL CREAMColgate-Palmolive Company
6 Jan 2011K103160NUPRO MODEL 13016901CAO Group, Inc.
22 Dec 2010K102808MI VARNISHGC America Inc.
21 Oct 2010K100172TOKUYAMA SHIELD FORCETokuyama Dental Corporation
23 Sep 2010K100540ASCENT F-COAT MODEL: 006-00097CAO Group, Inc.
12 May 2010K100503PULPDENT COPAL VARNISH WITH FLUORIDEPulpdent Corporation
10 Mar 2010K093620PULPDENT FLUORIDE VARNISHPulpdent Corporation
10 Mar 2010K092141VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH3M Espe Dental Products
5 Mar 2010K093575GLUMA DESENSITIZER POWER GELHeraeus Kulzer, LLC
15 Apr 2009K090519VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 122473M Company
19 Mar 2009K082594REMESENSERemedent NV
16 Mar 2009K090597FLUORILAQ SODIUM FLUORIDE CAVITY VARNISHPascal Co., Inc.
12 Jan 2009K083036VOCO PROFLUORID LVoco GmbH
29 Oct 2008K082198DURASHIELD PLUSDentsply Intl., Inc.
2 Oct 2008K082071ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENTAdpharma, Inc.
24 Jul 2008K080814VOCO PROFLUORID VARNISHVoco GmbH
27 Mar 2008K080228ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETHNovamin Technology, Inc.
29 Feb 2008K073061THE PROXIVENT KITColl Partners , Ltd.
8 Feb 2008K080249FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505Ultradent Products, Inc.
19 Dec 2007K073117DENTIN DESENSITIZER AGENTDentsply Intl., Inc.
3 Oct 2007K072342SULTAN TOOTH ROOT DESENSITIZERDentsply International, Inc.
21 Sep 2007K072338CERVITEC PLUSIvoclar Vivadent, AG
12 Jun 2007K061438ULTRAEZ DESENSITIZING GELUltradent Products, Inc.
25 May 2007K070070ASCENT DENTAL CLEANSERCAO Group, Inc.
18 May 2007K071267PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMINNovamin Technology, Inc.
4 May 2007K070289ACQUASEAL BENZAcquamed Technologies, Inc.
10 Jan 2007K062176RELIEF ACP ORAL CARE GELPhilips Medical Systems International BV
21 Nov 2006K062683ENAMEL PRO VARNISHPremier Dental Products Company
18 Oct 2006K061359DENSHIELD TREATMENT FOR SENSITIVE TEETHNovamin Technology, Inc.
16 Dec 2005K052263MULTIPLE (TOOTH DESENSITIZER)Cosmedent, Inc.
19 Sep 2005K051750FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502Ultradent Products, Inc.
7 Jun 2005K050486PROTECT TOOTH DESENSITIZERSunstar Butler
2 Sep 2004K040858ORALIEF THERAPY FOR SENSITIVE TEETHNovamin Technology, Inc.
10 Mar 2004K040473ORAVIVE TOOTH REVITALIZING PASTENovamin Technology, Inc.
4 Feb 2004K040098VARNISHAMERICAMedical Products Laboratories, Inc.
28 Oct 2003K033295BUTLER NUCARE ROOT CONDITIONER WITH NOVAMINNovamin Technology, Inc.
17 Oct 2003K030922VIVASENSIvoclar Vivadent, AG
15 Sep 2003K031932FLUORIDE VARNISHDentsply Intl., Inc.
2 May 2003K030488FLUORILAQPascal Co., Inc.
25 Nov 2002K023671AQUEOUS ACRYLIC DISPERSION 28% W/WChx Technologies, Inc.
26 Sep 2002K021131CHLORAPREPCentrix, Inc.
19 Aug 2002K021805SEAL & PROTECT PROTECTIVE SEALANTDentsply Intl., Inc.
12 Dec 2001K013411PULPDENT CAVITY PREPARATION IVPulpdent Corporation
25 Jun 2001K010957QUELL DESENSITIZERJeneric/Pentron, Inc.
20 Apr 2001K010255CAVITY VARNISHRite-Dent Manufacturing Corp.
1 Feb 2001K003482PROCLUDE-SENSITIVEOrtek Therapeutics, Inc.
20 Oct 2000K002581DURAGARD SODIUM FLUORIDE VARNISHSultan Dental Products, Ltd.
2 Mar 2000K994180PULPDENT CAVITY PREPARATION IIIPulpdent Corporation
29 Feb 2000K994181PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDEPulpdent Corporation
23 Feb 2000K994182PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDEPulpdent Corporation
17 Nov 1999K992822SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINEDentsply Intl., Inc.
17 Nov 1999K990779HEMASEAL & CIDEAdvantage Dental Products, Inc.
22 Oct 1999K992629D/SENSE II (GREEN-OR) DENTIN DESENSITIZERCentrix, Inc.
12 Feb 1999K982915SCI-PHARM DFV VARNISHScientific Pharmaceuticals
17 Dec 1998K983305SCI-PHARM DESENSITIZING VARNISHScientific Pharmaceuticals
7 Dec 1998K981972GREEN-OR DENTIN DESENSITIZERCentrix, Inc.
19 Mar 1998K974202PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUSPulpdent Corporation
18 Feb 1998K974398PULPDENT CAVITY VARNISHPulpdent Corporation
16 Dec 1997K973919CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)Medental Intl.
12 Dec 1996K963979ULTRADENT UNIVERSAL DENTIN SEALANTUltradent Products, Inc.
14 Aug 1996K961893DURAFLORPharmascience, Inc.
24 Jan 1996K955521ALPHA-DENT COPAL CAVITY VARNISHWallace A. Erickson & Co.
8 Sep 1995K953168ULTRACID F DISINFECTING SOLUTIONUltradent Products, Inc.
8 Sep 1995K953167ULTRACID DISINFECTING SOLOUTIONUltradent Products, Inc.
26 Jul 1995K945794DURAPHATInpharma
7 Mar 1995K946032FLUOR PROTECTORIvoclar North America, Inc.
9 Dec 1994K944934POLYURETHANE SOLUTION 29% W/WKnowell Therapeutic Technologies,Inc.
7 Jan 1994K933505BOSWORTH COPALIONERHarry J. Bosworth Co.
22 Jul 1993K925375CONSEPSIS SCRUBUltradent Products, Inc.
8 Jul 1993K924982CONSEPSIS(TM)Ultradent Products, Inc.
27 May 1993K931096DURAFLORPharmascience, Inc.
5 Mar 1993K924827MICRODOSE POTASSIUM OXYLATEUnicep
27 Jun 1990K901915DENTIN PROTECTORIvoclar North America, Inc.
29 May 1990K901049COPAL VARNISHPulpdent Corporation
25 May 1990K900946UNIVERSUMScientific Pharmaceuticals
1 Jul 1988K880741ESPE VARNISHEspe GmbH (Us)
1 Jun 1988K881026CONTAC, A DENTIN SEALANTHarry J. Bosworth Co.
10 Dec 1986K864051TUBULICID RED LABELDental Dimensions Supply Co.
5 Dec 1986K864052TUBULITEC PRIMERDental Dimensions Supply Co.
5 Dec 1986K864050TUBULICID BLUE LABELDental Dimensions Supply Co.
11 Apr 1986K860633FLUOROSEAL, DENTIN SEALER AND CAVITY LINERScientific Pharmaceuticals
23 Sep 1985K852755UNIVAR UNIVERSAL DENTIN VARNISHScientific Pharmaceuticals
31 Jul 1985K852756TELEDYNE GETZ BARRIER-DENTIN SEALERScientific Pharmaceuticals
31 Jul 1985K851052TUBULITEC PRIMERDental Therapeutics AB
20 Jun 1985K851030TEMREX-DENTIN VARNISHTemrex Corp.
13 Jan 1984K833701ACA THYROXINE ANALYTICAL TEST PACKE.I. Dupont DE Nemours & Co., Inc.
4 Oct 1983K832497CAVITY CLEANSERDen-Mat Corp.
25 Sep 1981K812550BEAUCAVSci-Pharm, Inc.
25 Sep 1981K812548COBEAUSci-Pharm, Inc.
21 Sep 1981K810913CAVITY VARNISHDentsply Intl., Inc.
19 Dec 1980K802926SCI-PHARM UNIVERSAL CAVITY VARNISHScientific Pharmaceuticals
20 May 1980K801047PLY LESIVEMay-Pell Chemical Development Co.
12 Mar 1980K800438DENTAL CAVITY VARNISH, CONCENTRATEDScientific Pharmaceuticals
15 Nov 1976K760982DENTAL VARNISHAdp Intl., Inc.
27 Sep 1976K760660HYDROLSeptodont

Official records: FDA product classification for LBH · 21 CFR 872.3260.

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