Varnish, Cavity
FDA product code LBH · Class II (moderate risk) · 21 CFR 872.3260 · Dental
139510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Pulpdent Corp. 10
- Scientific Pharmaceuticals, Inc. 9
- Ultradent Products, Inc. 9
- Dentsply Intl. 6
- Novamin Technology, Inc. 6
- Centrix, Inc. 5
- Ivoclar Vivadent, Inc. 4
- Dental Dimensions Supply Co. 3
- CAO Group, Inc. 3
- Voco GmbH 3
- Sylphar N.V. 2
- Dentsply International, Inc. 2
- Harry J. Bosworth Co. 2
- Colgate Palmolive Company 2
- Sci-Pharm, Inc. 2
- Ivoclar North America, Inc. 2
- 3M Espe Dental Products 2
- Pharmascience, Inc. 2
- 3M Company 2
- Pascal Co., Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | Kettenbach GmbH & Co. KG | 09/03/2026SE |
| K253052 | Fluoride Varnish (Type A,Type C)LBH · Traditional | Nagy Oral Technology Qinhuangdao Co., Ltd. | 06/11/2026SE |
| K252073 | VOCO Profluorid Varnish + BioMinLBH · Traditional | Voco GmbH | 05/01/2026SE |
| K261404 | UltraEZLBH · Special | Ultradent Products, Inc. | 04/30/2026SE |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)LBH · Traditional | Sangi Co., Ltd. | 03/18/2026SE |
| K250714 | FluoroDose VarnishLBH · Traditional | Centrix, Inc. | 11/21/2025SE |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3%…LBH · Traditional | Theodent, LLC | 05/27/2025SE |
| K241489 | ReminGelLBH · Traditional | Inter-Med, Inc. | 01/08/2025SE |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-PlusLBH · Traditional | GreenMark Biomedical, Inc. | 01/02/2025SE |
| K242913 | Jasmate® ToothpasteLBH · Traditional | Jasberry Healthcare Private Limited | 11/22/2024SE |
| K233768 | Papacarie DuoLBH · Traditional | Elevate Oral Care | 07/18/2024SE |
| K231060 | ProMin Dental Desensitizing GelLBH · Traditional | Belport Company, Inc., Gingi-Pak | 06/13/2024SE |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…LBH · Traditional | Kettenbach GmbH & Co. KG | 07/24/2023SE |
| K222891 | Dental DesensitizerLBH · Traditional | Guangzhou Beogene Biotech Co., Ltd. | 05/25/2023SE |
| K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride TreatmentLBH · Traditional | 3M Espe Dental Products | 05/10/2023SE |
| K220419 | Apapro DesensitizerLBH · Traditional | Sangi Co., Ltd. | 02/16/2022SE |
| K200077 | BioMin Restore PlusLBH · Traditional | Dr. Collins, Inc. | 11/06/2020SE |
| K200614 | FiteBac Antimicrobial Cavity CleanserLBH · Traditional | Largent Health, LLC | 06/25/2020SE |
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum…LBH · Traditional | Scientific Pharmaceuticals | 02/18/2020SE |
| K191453 | Cervitec FLBH · Traditional | Ivoclar Vivadent, AG | 02/11/2020SE |
| K190271 | FiteBac Cavity CleanserLBH · Traditional | Largent Health, LLC | 01/23/2020SE |
| K182917 | FluoroCalLBH · Traditional | Bisco, Inc. | 11/18/2019SE |
| K181965 | Restore ToothpasteLBH · Traditional | Dr. Collins, Inc. | 06/13/2019SE |
| K160377 | V-varnish PremiumLBH · Traditional | Vericom Co., Ltd. | 12/02/2016SE |
| K153334 | Oral-B 5% Sodium Fluoride VarnishLBH · Traditional | Young Dental Manufacturing Co. 1, LLC | 05/20/2016SE |
| K151302 | Clinpro VarnishLBH · Traditional | 3M Company | 09/18/2015SE |
| K143155 | LISTERINE Sensitivity Defense MouthrinseLBH · Traditional | Johnson & Johnson Healthcare Products, Division… | 01/29/2015SE |
| K140350 | Vella 5% Sodium Fluoride Varnish with Nufluor and XylitolLBH · Traditional | Preventive Technologies, Inc. | 12/12/2014SE |
| K131487 | Fluor Protector SLBH · Traditional | Ivoclar Vivadent, AG | 10/08/2014SE |
| K141422 | Profluoro Fluoride VarnishLBH · Traditional | Pac-Dent International, Inc. | 09/30/2014SE |
| K140349 | Starbright 5% Sodium Fluoride VarnishLBH · Traditional | Nanova Biomaterials, Inc. | 09/22/2014SE |
| K140481 | Colgate Desensitizing Mouthrinse, Colgate Sensitive Pro-Relief MouthwashLBH · Traditional | Colgate-Palmolive Company | 06/05/2014SE |
| K132426 | Sylphar Remesense Sensitivity Relief StripsLBH · Traditional | Sylphar N.V. | 02/14/2014SE |
| K132109 | EnamelastLBH · Traditional | Ultradent Products Inc. / Oratech, LLC | 11/01/2013SE |
| K124025 | Alpha-Pro White VarnishLBH · Traditional | Dental Technologies, Inc. | 09/18/2013SE |
| K131376 | Smartcoat 2.5% Naf VarnishLBH · Traditional | Elevate Oral Care | 08/27/2013SE |
| K123653 | Seal Block Pro (Not Finalized), Seal Block OTC (Not Finalized)LBH · Traditional | Bisco, Inc. | 06/03/2013SE |
| K122908 | PRG Barrier CoatLBH · Traditional | Shofu Dental Corporation | 04/26/2013SE |
| K122708 | Remesense for Sensitive TeethLBH · Traditional | Sylphar N.V. | 01/14/2013SE |
| K122331 | Cavity VarnishLBH · Traditional | Dentsply International, Inc. | 10/15/2012SE |
| K120176 | Senzzzzz AwayLBH · Traditional | Centrix, Inc. | 07/25/2012SE |
| K120109 | Super Seal Tooth DesensitizerLBH · Traditional | Phoenix Dental, Inc. | 03/07/2012SE |
| K113146 | PCXX VarnishLBH · Abbreviated | Ross Healthcare, Inc. | 01/23/2012SE |
| K112946 | Activ VarnishLBH · Traditional | Pulpdent Corporation | 12/09/2011SE |
| K103461 | Colgate Desensitizing Dental CreamLBH · Traditional | Colgate-Palmolive Co. | 09/13/2011SE |
| K103160 | Nupro Model 13016901LBH · Traditional | CAO Group, Inc. | 01/06/2011SE |
| K102808 | Mi VarnishLBH · Traditional | GC America, Inc. | 12/22/2010SE |
| K100172 | Tokuyama Shield ForceLBH · Traditional | Tokuyama Dental Corporation | 10/21/2010SE |
| K100540 | Ascent F-Coat Model: 006-00097LBH · Traditional | CAO Group, Inc. | 09/23/2010SE |
| K100503 | Pulpdent Copal Varnish with FluorideLBH · Traditional | Pulpdent Corporation | 05/12/2010SE |
| K093620 | Pulpdent Fluoride VarnishLBH · Traditional | Pulpdent Corporation | 03/10/2010SE |
| K092141 | Vanish Varnish, 5% Sodium Fluoride White VarnishLBH · Traditional | 3M Espe Dental Products | 03/10/2010SE |
| K093575 | Gluma Desensitizer Power GelLBH · Traditional | Heraeus Kulzer, LLC | 03/05/2010SE |
| K090519 | Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride…LBH · Special | 3M Company | 04/15/2009SE |
| K082594 | RemesenseLBH · Traditional | Remedent NV | 03/19/2009SE |
| K090597 | Fluorilaq Sodium Fluoride Cavity VarnishLBH · Special | Pascal Co., Inc. | 03/16/2009SE |
| K083036 | Voco Profluorid LLBH · Traditional | Voco GmbH | 01/12/2009SE |
| K082198 | Durashield PlusLBH · Traditional | Dentsply Intl., Inc. | 10/29/2008SE |
| K082071 | Adpharma Occlude and Occlude F Dentin Tubule AgentLBH · Traditional | Adpharma, Inc. | 10/02/2008SE |
| K080814 | Voco Profluorid VarnishLBH · Traditional | Voco GmbH | 07/24/2008SE |
| K080228 | Oralief OTC Toothpaste for Sensitive TeethLBH · Traditional | Novamin Technology, Inc. | 03/27/2008SE |
| K073061 | The Proxivent KitLBH · Traditional | Coll Partners , Ltd. | 02/29/2008SE |
| K080249 | Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505LBH · Special | Ultradent Products, Inc. | 02/08/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | Dentsply Intl., Inc. | 12/19/2007SE |
| K072342 | Sultan Tooth Root DesensitizerLBH · Traditional | Dentsply International, Inc. | 10/03/2007SE |
| K072338 | Cervitec PlusLBH · Traditional | Ivoclar Vivadent, Inc. | 09/21/2007SE |
| K061438 | Ultraez Desensitizing GelLBH · Traditional | Ultradent Products, Inc. | 06/12/2007SE |
| K070070 | Ascent Dental CleanserLBH · Traditional | CAO Group, Inc. | 05/25/2007SE |
| K071267 | Periosrp Tooth Root Conditioner with NovaminLBH · Special | Novamin Technology, Inc. | 05/18/2007SE |
| K070289 | Acquaseal BenzLBH · Traditional | Acquamed Technologies, Inc. | 05/04/2007SE |
| K062176 | Relief Acp Oral Care GelLBH · Traditional | Discus Dental, Inc. | 01/10/2007SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | Premier Dental Products Co. | 11/21/2006SE |
| K061359 | Denshield Treatment for Sensitive TeethLBH · Traditional | Novamin Technology, Inc. | 10/18/2006SE |
| K052263 | Multiple (Tooth Desensitizer)LBH · Traditional | Cosmedent, Inc. | 12/16/2005SE |
| K051750 | Flor-Opal Varnish, Models Up 4500/ Up 4501/ Up 4502LBH · Traditional | Ultradent Products, Inc. | 09/19/2005SE |
| K050486 | Protect Tooth DesensitizerLBH · Traditional | Sunstar Butler | 06/07/2005SE |
| K040858 | Oralief Therapy for Sensitive TeethLBH · Traditional | Novamin Technology, Inc. | 09/02/2004SE |
| K040473 | Oravive Tooth Revitalizing PasteLBH · Traditional | Novamin Technology, Inc. | 03/10/2004SE |
| K040098 | VarnishamericaLBH · Traditional | Medical Products Laboratories, Inc. | 02/04/2004SE |
| K033295 | Butler Nucare Root Conditioner with NovaminLBH · Traditional | Novamin Technology, Inc. | 10/28/2003SE |
| K030922 | VivasensLBH · Traditional | Ivoclar Vivadent, Inc. | 10/17/2003SE |
| K031932 | Fluoride VarnishLBH · Traditional | Dentsply Intl. | 09/15/2003SE |
| K030488 | FluorilaqLBH · Traditional | Pascal Co., Inc. | 05/02/2003SE |
| K023671 | Aqueous Acrylic Dispersion 28% W/WLBH · Special | Chx Technologies, Inc. | 11/25/2002SE |
| K021131 | ChloraprepLBH · Traditional | Centrix, Inc. | 09/26/2002SE |
| K021805 | Seal & Protect Protective SealantLBH · Traditional | Dentsply Intl. | 08/19/2002SE |
| K013411 | Pulpdent Cavity Preparation IVLBH · Traditional | Pulpdent Corp. | 12/12/2001SE |
| K010957 | Quell DesensitizerLBH · Traditional | Jeneric/Pentron, Inc. | 06/25/2001SE |
| K010255 | Cavity VarnishLBH · Traditional | Rite-Dent Manufacturing Corp. | 04/20/2001SE |
| K003482 | Proclude-SensitiveLBH · Traditional | Ortek Therapeutics, Inc. | 02/01/2001SE |
| K002581 | Duragard Sodium Fluoride VarnishLBH · Traditional | Sultan Dental Products, Ltd. | 10/20/2000SE |
| K994180 | Pulpdent Cavity Preparation IIILBH · Traditional | Pulpdent Corp. | 03/02/2000SE |
| K994181 | Pulpdent Cavity Preparation II, Pulpdent Cavity Preparation II Wuth FluorideLBH · Traditional | Pulpdent Corp. | 02/29/2000SE |
| K994182 | Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 with FluorideLBH · Traditional | Pulpdent Corp. | 02/23/2000SE |
| K992822 | Seal & Protect Protective Sealant for Exposed DentineLBH · Traditional | Dentsply Intl. | 11/17/1999SE |
| K990779 | Hemaseal & CideLBH · Traditional | Advantage Dental Products, Inc. | 11/17/1999SE |
| K992629 | D/Sense II (Green-Or) Dentin DesensitizerLBH · Traditional | Centrix, Inc. | 10/22/1999SE |
| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | Scientific Pharmaceuticals, Inc. | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | Scientific Pharmaceuticals, Inc. | 12/17/1998SE |
| K981972 | Green-Or Dentin DesensitizerLBH · Traditional | Centrix, Inc. | 12/07/1998SE |
| K974202 | Pulpdent Cavity Cleanser, Pulpdent Cavity Cleanser PlusLBH · Traditional | Pulpdent Corp. | 03/19/1998SE |
| K974398 | Pulpdent Cavity VarnishLBH · Traditional | Pulpdent Corp. | 02/18/1998SE |
| K973919 | Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)LBH · Traditional | Medental Intl. | 12/16/1997SE |
| K963979 | Ultradent Universal Dentin SealantLBH · Traditional | Ultradent Products, Inc. | 12/12/1996SE |
| K961893 | DuraflorLBH · Traditional | Pharmascience, Inc. | 08/14/1996SE |
| K955521 | Alpha-Dent Copal Cavity VarnishLBH · Traditional | Wallace A. Erickson & Co. | 01/24/1996SE |
| K953168 | Ultracid F Disinfecting SolutionLBH · Traditional | Ultradent Products, Inc. | 09/08/1995SE |
| K953167 | Ultracid Disinfecting SoloutionLBH · Traditional | Ultradent Products, Inc. | 09/08/1995SE |
| K945794 | DuraphatLBH · Traditional | Inpharma | 07/26/1995SE |
| K946032 | Fluor ProtectorLBH · Traditional | Ivoclar North America, Inc. | 03/07/1995SE |
| K944934 | Polyurethane Solution 29% W/WLBH · Traditional | Knowell Therapeutic Technologies,Inc. | 12/09/1994SE |
| K933505 | Bosworth CopalionerLBH · Traditional | Harry J. Bosworth Co. | 01/07/1994SE |
| K925375 | Consepsis ScrubLBH · Traditional | Ultradent Products, Inc. | 07/22/1993SE |
| K924982 | Consepsis(Tm)LBH · Traditional | Ultradent Products, Inc. | 07/08/1993SE |
| K931096 | DuraflorLBH · Traditional | Pharmascience, Inc. | 05/27/1993SE |
| K924827 | Microdose Potassium OxylateLBH · Traditional | Unicep | 03/05/1993SE |
| K901915 | Dentin ProtectorLBH · Traditional | Ivoclar North America, Inc. | 06/27/1990SE |
| K901049 | Copal VarnishLBH · Traditional | Pulpdent Corp. | 05/29/1990SE |
| K900946 | UniversumLBH · Traditional | Scientific Pharmaceuticals, Inc. | 05/25/1990SE |
| K880741 | Espe VarnishLBH · Traditional | Espe GmbH (Us) | 07/01/1988SE |
| K881026 | Contac, a Dentin SealantLBH · Traditional | Harry J. Bosworth Co. | 06/01/1988SE |
| K864051 | Tubulicid Red LabelLBH · Traditional | Dental Dimensions Supply Co. | 12/10/1986SE |
| K864052 | Tubulitec PrimerLBH · Traditional | Dental Dimensions Supply Co. | 12/05/1986SE |
| K864050 | Tubulicid Blue LabelLBH · Traditional | Dental Dimensions Supply Co. | 12/05/1986SE |
| K860633 | Fluoroseal, Dentin Sealer and Cavity LinerLBH · Traditional | Scientific Pharmaceuticals, Inc. | 04/11/1986SE |
| K852755 | Univar Universal Dentin VarnishLBH · Traditional | Scientific Pharmaceuticals, Inc. | 09/23/1985SE |
| K852756 | Teledyne Getz Barrier-Dentin SealerLBH · Traditional | Scientific Pharmaceuticals, Inc. | 07/31/1985SE |
| K851052 | Tubulitec PrimerLBH · Traditional | Dental Therapeutics AB | 07/31/1985SE |
| K851030 | Temrex-Dentin VarnishLBH · Traditional | Temrex Corp. | 06/20/1985SE |
| K833701 | Aca Thyroxine Analytical Test PackLBH · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 01/13/1984SE |
| K832497 | Cavity CleanserLBH · Traditional | Den-Mat Corp. | 10/04/1983SE |
| K812550 | BeaucavLBH · Traditional | Sci-Pharm, Inc. | 09/25/1981SE |
| K812548 | CobeauLBH · Traditional | Sci-Pharm, Inc. | 09/25/1981SE |
| K810913 | Cavity VarnishLBH · Traditional | Dentsply Intl. | 09/21/1981SE |
| K802926 | Sci-Pharm Universal Cavity VarnishLBH · Traditional | Scientific Pharmaceuticals, Inc. | 12/19/1980SE |
| K801047 | Ply LesiveLBH · Traditional | May-Pell Chemical Development Co. | 05/20/1980SE |
| K800438 | Dental Cavity Varnish, ConcentratedLBH · Traditional | Scientific Pharmaceuticals, Inc. | 03/12/1980SE |
| K760982 | Dental VarnishLBH · Traditional | Adp Intl., Inc. | 11/15/1976SE |
| K760660 | HydrolLBH · Traditional | Septodont, Inc. | 09/27/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2579-2023 Class II | Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal…A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526)… | Keystone Industries | 07/21/2023Open, Classified |
| Z-1697-2023 Class II | BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnishThe Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum. | Young Dental Manufacturing I, LLC | 05/23/2023Open, Classified |
| Z-0661-2020 Class II | Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product…Product shelf life may be shorter than that indicated on the label. | Young Dental Manufacturing Co, LLC | 10/30/2019Open, Classified |
| Z-0690-2019 Class II | Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint:…Dental varnish has the possibility of having an unpleasant and off flavor. | Ultradent Products, Inc. | 07/12/2018Terminated |
| Z-0368-2019 Class II | 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack…Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material… | 3M Company - Health Care Business | 07/06/2018Terminated |
| Z-0425-2015 Class II | Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold…Product sold after April 1, 2014 were inadvertently filled with hydrogen peroxide teeth whitening gel (6%… | Discus Dental LLC | 10/24/2014Terminated |
| Z-0476-2015 Class II | Dharma Cavity Varnish 15mLDuring an FDA inspection it was found that the products are marketed without a cleared 510k. | Dharma Research, Inc. | 09/29/2014Terminated |
| Z-0475-2015 Class II | Dharma Cavity Varnish with FluorideDuring an FDA inspection, it was found that the products are being marketed without a cleared 510k. | Dharma Research, Inc. | 09/29/2014Terminated |
| Z-1651-2014 Class II | Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For…The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application… | Heraeus Kulzer, LLC. | 04/23/2014Terminated |