Sealants & varnishes: manufacturers and brands
65 companies make or specify dental sealants among the 106 that list one with FDA, under 328 brand and model names. FDA has issued 271 510(k) clearances in this category, 21 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental sealant manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Delton Clear Pit & Fissure · Delton FS+ · Delton Opaque Pit & Fissure Sealant · Delton Pit & Fissure Sealant, · +3 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Com Seal · Any-Com Kit · Any-Com Universal Kit · Hi-Bond Universal | 15 | 2026 |
| Voco GmbH | Germany | Maker | Admira Protect · Admira Protect Single Dose · Control Seal · Grandio Seal · +5 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | Proseal Enamel Coating Resin | 13 | 2025 |
| Shofu Inc | Japan | Maker | BEAUTISEALANT · PRG BARRIER COAT | 96 | 2025 |
| GC America Inc. | United States | Maker | G-aenial Injection Matrix Kit · G-aenial Universal Flo · GC Fuji Triage EP · MI Fil · +9 | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | GUARDIAN SEAL · SimpliShade Self-Adhesive Flow · SonicFill 2 · SonicFill 3 · +1 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Consepsis · Consepsis Scrub · Consepsis V · Consumer Opalescence Sensitivity Relief · +9 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Gluma Comfort Bond + Desensitizer · iBond Total Etch · Venus Bulk Flow One · Venus Diamond · +2 | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Adhese 100 · Adhese Universal · Adhese Universal DC · Adhese Universal kit VivaPen · +9 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CLEARFIL SE Protect · CLEARFIL Universal Bond · CLEARFIL Universal Bond Kit · KATANA Cleaner | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | REGEN Pit & Fissure Sealant · ReminGel | 7 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Jet Flow Bulk | 24 | 2024 |
| Deltamed GmbH | Germany | Maker | COSMESEAL® Clear · COSMESEAL® Filled | 6 | 2024 |
| Premier Dental Products Company | United States | Maker | Bond-PR · ENAMEL PRO VARNISH · TastyTooth Varnish · BioCoat · +1 | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Flowable Composite · PIT & FISSURE SEALANT · Put & Fissure Sealant Light Curing · D-Lish 5% Sodium Fluoride Varnish - Assorted · +9 | 23 | 2025 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Profisil · Profisil Free | 14 | 2026 |
| Sdi Limited | Australia | Maker | Conseal F · Conseal Grey · Conseal White · Riva Coat · +9 | 8 | 2022 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Flowable Restorative Material(KP-Flow LF, KP-Flow MF, KP-Flow HF) | 3 | 2026 |
| Bisco, Inc. | United States | Maker | BIS-SILANE · OPAQUER D/C · PORCELAIN PRIMER | 88 | 2025 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Centrix, Inc. | United States | Maker | D/Sense Crystal · FluoroDose | 44 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | Eco-S | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | 10055009 | 10 | 2024 |
| Den-Mat Holdings, LLC | United States | Maker | Fluoridex Varnish · G-BLOCK · G5 | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | Promin 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 ml | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe · Nova Compo HF, Othocompo, Luxera, Maritza · Nova Resin Cement | 5 | 2022 |
| DMP Dental Industry S.A. | Greece | Maker | BRIGHT FLOW CORE · BRIGHT LIGHT · BRIGHT LIGHT FLOW · BRIGHT POSTERIOR · +2 | 3 | 2026 |
| Elevate Oral Care | United States | Maker | FluoriMax · PapaCarie Duo | 3 | 2024 |
| Keystone Industries | United States | Maker | Bosworth Pit & Fissure Sealant with Fluoride · Copaliner | 2 | 2025 |
| HDI Inc. | South Korea | Maker | DENU Composite Resin · DENU Flow Resin | 2 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Constic A1 · Constic A2 · Constic A3 · Constic A3,5 · +15 | 4 | 2022 |
| Pulpdent Corporation | United States | Maker | Embrace Pit & Fissure Sealant · Embrace WetBond Pit & Fissure Seal · Ortho-Choice Ortho-Coat · Seal-Rite Low Viscosity · +6 | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Barrier · Fluoroseal · Sci-Pharm Copal · Sci-Pharm DFV · +4 | 73 | 2020 |
| Sterngold | United States | Maker | Stern Omega | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Tokuyama Dental Corporation | Japan | Maker | TOKUYAMA SHIELD FORCE · TOKUYAMA SHIELD FORCE PLUS | 19 | 2021 |
| Philips Medical Systems International BV | Netherlands | Maker | Relief ACP Oral Care Gel | 16 | 2010 |
| CAO Group, Inc. | United States | Maker | BlissBond · BlissEtch · LEAP Cavity Cleansing Solution | 13 | 2020 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Visible Light Cure Pit and Fissure | 9 | 2012 |
| ITENA Clinical | France | Maker | EBC / SEALANT, PIT AND FISSURE, AND CONDITIONER | 8 | 2017 |
| Colgate-Palmolive Company | United States | Maker | Tom's of Maine Hydroxyapatite Gentle Mint · Tom's of Maine Sensitive + Rapid Relief Toothpaste · Tom's of Maine Sensitive + Whitening Toothpaste | 6 | 2014 |
| Nanova Biomaterials Inc | United States | Maker | NovaBright 5% NaF Varnish · StarBright 5% NaF Varnish | 5 | 2018 |
| Preventive Technologies, Inc. | United States | Maker | VELLA 5% Sodium Fluoride Varnish with NUFLUOR and XYLITOL | 3 | 2014 |
| Advantage Dental Products, Inc. | United States | Maker | Hemaseal & Cide · Hemaseal & Cide Unidose | 3 | 1999 |
| Dental Technologies, Inc. | United States | Maker | Alpha-dent Light Cure Bonding Adhesive · Alpha-Dent Light Cure Pit & Fissure Sealant · Alpha-Dent Self Cure Pit & Fissure Sealant · Alpha-Seal · +3 | 2 | 2013 |
| Temrex Corp. | United States | Maker | COPALITE | 2 | 2012 |
| Denali R & D Corporation | United States | Maker | AURA Lay · Bonita | 2 | 2009 |
| Medical Products Laboratories, Inc. | United States | Maker | — | 2 | 2004 |
| Chx Technologies, Inc. | Canada | Maker | PREVORA STAGE 2 | 1 | 2002 |
| B.J.M. Laboratories Ltd | Israel | Maker | Biocoat Sealant · Enamel Loc · MultiMatch Flow Chameleon AntiMicrobial Composite · Premier Self-Etching Enamel Sealant · +4 | — | — |
| Pascal International | United States | Maker | Fluorilaq · Fluorilaq Squeeze · Fluorilaq Unit Dose | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA LC Nano Hybrid Composite · IDENTA LC Nano Hybrid Flowable Composite · IDENTA Fluoride-containing Desensitizing Varnish | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Maker | — | — | — |
| medmix Deutschland GmbH | Germany | Maker | IBOND TOTAL ETCH | — | — |
| O&S Dental Inc | United States | Maker | — | — | — |
| Conamco | United States | Maker | Medental | — | — |
| indigodental GmbH | Germany | Maker | — | — | — |
| Cetylite Industries, Inc. | United States | Maker | Varnal · Zarosen | — | — |
| F & A laboratorio Farmaceutico Ltda | Brazil | Maker | PapaCarie Duo | — | — |
| Voyant Beauty Inc | Canada | Maker | LISTERINE CLINICAL SOLUTIONS SENSITIVE TEETH MOUTHWASH · LISTERINE SENSITIVITY ZERO ALCOHOL MOUTH RINSE | — | — |
| Cumberland Biotherapeutics, LLC. | United States | Maker | DentoClude F | — | — |
| Kenvue Brands LLC | United States | Maker | Listerine | — | — |
| Silgan Unicep | United States | Maker | Therma-Trol | — | — |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | CosmeSeal · PorcelEtch · Desensitizer | 27 | 2024 |
| NuSmile, Ltd. | United States | Manufacturer | NuSmile NuNamel Varnish · NuSmile NuNamel Sealant | 2 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Unilite Flow · Unilite Flow Kit · Unilite Universal Composite | 2 | 2025 |
| Dent Zar, Inc. | United States | Repacker / relabeler | — | 12 | 1996 |
| Medental Intl. | United States | Repacker / relabeler | Medental · Medental Pit and Fissure Sealant with Orhothophosphoric Acid (Conditioner) | 7 | 1999 |
| George Taub Products & Fusion Co., Inc. | United States | Manufacturer | Kidz Seal | 2 | 1986 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Pit & Fissure Sealant Clear · ADS Pit & Fissure Sealant Opaque · Khameo Pit & Fissure Sealant Clear · Khameo Pit & Fissure Sealant Opaque · +5 | 1 | 2015 |
| DMG America, L.L.C. | United States | Contract manufacturer | Varnish, Cavity - Kolorz | 1 | 2013 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | Select Defense | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | BEAUTISEALANT · DMC COMPOSITE 2 · G-aenial · HELIOSEAL · +7 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Coating · Dental cement · Pit & FIssure · Sealant · +6 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | G-aenial Injection Matrix Kit; G-aenial Universal Flo; MI Fil · Patterson Pit & Fissure Sealant · Patterson Pit and Fissure Sealant · Patterson Tooth Shade Resin Material · +2 | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Visible Chemical Cure Pit and Fissure · Visible Light Cure Pit and Fissure | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | dental filling · Flow · Pit & Fissure · Sealant · +5 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Clinpro Syringe · Sonicfill Composite · Vertise Flow | — | — |
| SPS/Crosstex International | United States | Manufacturer | Sparkle V Varnish | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Material, Tooth shade, Resin | — | — |
| AMD Medicom Inc | Canada | Foreign exporter | Medicom Duraflor Halo Varnish · Medicom Duraflor Varnish | — | — |
| Viarden Lab LLC | United States | Manufacturer for export | PIT AND FISSURE SEALNT VIARDEN LAB, IONGLASS SEALER · C-PROTECTOR VIARDEN LAB, CAVITY VARNISH, VIARVEER, DENT AG PROTEC | — | — |
| Bina Limited | Belize | Foreign exporter | SEALANT | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent · Material, Tooth Shade, Resin | — | — |
| NU Radiance, Inc. | United States | Repacker / relabeler | Nu Radiance Pit and Fissure Sealant · Nu Shield | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| Summit Packaging Solutions LLC | United States | Repacker / relabeler | cavity Varnish | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | Material, tooth shade, resin | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | BEAUTISEALANT | — | — |
| HEXA Dental | United States | Contract manufacturer | — | — | — |
| Menasha Packaging Co. LLC | United States | Repacker / relabeler | Varnish, Cavity | — | — |
| Oral Biotech | United States | Repacker / relabeler | CariFree Fluoride Varnish | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| MN Health Inc, | United States | Repacker / relabeler | — | — | — |
| The Atlanta Dental supply Company | United States | Repacker / relabeler | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental sealants are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Cavity VarnishLBH | 2 | 872.3260 | 48 | 140 |
| Pit and Fissure Sealant and ConditionerEBC | 2 | 872.3765 | 39 | 131 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Oct 2026 | K262775 | AquaVance Clear Fluoride Treatment | The Belport Company, Inc. DBA Gingi-Pak | LBH Cavity Varnish |
| 3 Sep 2026 | K262243 | Profisil Free | Kettenbach GmbH & Co. KG | LBH Cavity Varnish |
| 11 Jun 2026 | K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | LBH Cavity Varnish |
| 1 May 2026 | K260819 | Any-Com Seal | Mediclus Co., Ltd | EBC Pit and Fissure Sealant and Conditioner |
| 1 May 2026 | K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | LBH Cavity Varnish |
| 30 Apr 2026 | K261404 | UltraEZ | Ultradent Products, Inc. | LBH Cavity Varnish |
| 18 Mar 2026 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | LBH Cavity Varnish |
| 21 Nov 2025 | K250714 | FluoroDose Varnish | Centrix, Inc. | LBH Cavity Varnish |
| 8 Aug 2025 | K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc | EBC Pit and Fissure Sealant and Conditioner |
| 27 May 2025 | K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC | LBH Cavity Varnish |
| 8 Jan 2025 | K241489 | ReminGel | Inter-Med, Inc. | LBH Cavity Varnish |
| 2 Jan 2025 | K241568 | CrystLCare PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical Inc. | LBH Cavity Varnish |
| 22 Nov 2024 | K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | LBH Cavity Varnish |
| 18 Jul 2024 | K233768 | Papacarie Duo | Elevate Oral Care | LBH Cavity Varnish |
| 13 Jun 2024 | K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | LBH Cavity Varnish |
| 18 Aug 2023 | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 25 Jul 2023 | K230455 | Enamel Coating Resin | Rizhao HuGe Biomaterials Company, Ltd. | EBC Pit and Fissure Sealant and Conditioner |
| 24 Jul 2023 | 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) | Kettenbach GmbH & Co. KG | LBH Cavity Varnish |
| 25 May 2023 | K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | LBH Cavity Varnish |
| 10 May 2023 | K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | LBH Cavity Varnish |
| 16 Feb 2022 | K220419 | Apapro Desensitizer | Sangi Co., Ltd. | LBH Cavity Varnish |
| 6 Nov 2020 | K200077 | BioMin Restore Plus | Dr. Collins, Inc. | LBH Cavity Varnish |
| 25 Jun 2020 | K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | LBH Cavity Varnish |
| 18 Feb 2020 | 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 | Scientific Pharmaceuticals | LBH Cavity Varnish |
| 11 Feb 2020 | K191453 | Cervitec F | Ivoclar Vivadent, AG | LBH Cavity Varnish |
| 23 Jan 2020 | K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | LBH Cavity Varnish |
| 18 Nov 2019 | K182917 | FluoroCal | Bisco, Inc. | LBH Cavity Varnish |
| 8 Nov 2019 | K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 29 Jul 2019 | K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | EBC Pit and Fissure Sealant and Conditioner |
| 13 Jun 2019 | K181965 | Restore Toothpaste | Dr. Collins, Inc. | LBH Cavity Varnish |
| 5 Jan 2018 | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | EBC Pit and Fissure Sealant and Conditioner |
| 8 Sep 2017 | K171330 | Nanova Sealant | Nanova Biomaterials Inc | EBC Pit and Fissure Sealant and Conditioner |
| 23 May 2017 | K162598 | HAPI Seal | Bisco, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 2 Dec 2016 | K160377 | V-varnish Premium | Vericom Co., Ltd. | LBH Cavity Varnish |
| 18 Oct 2016 | K161580 | Premier Sealant | Premier Dental Company Products | EBC Pit and Fissure Sealant and Conditioner |
| 20 May 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Innovations Inc | LBH Cavity Varnish |
| 18 Sep 2015 | K151302 | Clinpro Varnish | 3M Company | LBH Cavity Varnish |
| 9 Mar 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 29 Jan 2015 | K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | LBH Cavity Varnish |
| 12 Dec 2014 | K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | Preventive Technologies, Inc. | LBH Cavity Varnish |