Prosthetic devices · 21 CFR 872 Subpart D
Pit and Fissure Sealant and Conditioner
FDA device type “Sealant, Pit And Fissure, And Conditioner”.
- Companies listing it
- 7639 makers
- Brands and models
- 179
- 510(k) clearances
- 1314 in five years
- FDA name
- Sealant, Pit And Fissure, And Conditioner
510(k) clearances per year, 1976–2026
Companies that list EBC
76 companies currently list this device type with FDA.
| 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, · +2 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Com Seal | 15 | 2026 |
| Voco GmbH | Germany | Maker | Admira Protect · Admira Protect Single Dose · Control Seal · Grandio Seal · +2 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | Proseal Enamel Coating Resin | 13 | 2025 |
| Shofu Inc | Japan | Maker | BEAUTISEALANT | 96 | 2025 |
| GC America Inc. | United States | Maker | Essentia · G-aenial Flo · G-aenial Injectable Pro · G-aenial Injectable Pro Bulk · +7 | 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 | PrimaDry · UltraSeal XT hydro · UltraSeal XT hydro bioprotection by Nobio · UltraSeal XT Plus · +1 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Venus Bulk Flow One · Venus Diamond · Venus Diamond Flow · Venus Pearl | 37 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Helioseal Clear · Helioseal F Plus · IPS Empress Direct Effect | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | REGEN Pit & Fissure Sealant | 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 | BioCoat · MultiMatch Flow Chameleon AntiMicrobial Composite | 28 | 2026 |
| Sdi Limited | Australia | Maker | Conseal F · Conseal Grey · Conseal White · Riva Coat · +5 | 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 |
| Vericom Co., Ltd. | South Korea | Maker | Eco-S | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | 10055009 | 10 | 2024 |
| 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 |
| Keystone Industries | United States | Maker | Bosworth Pit & Fissure Sealant with Fluoride | 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 · +2 | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Sci-Pharm · Sun-Schein | 73 | 2020 |
| Sterngold | United States | Maker | Stern Omega | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| 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 |
| Nanova Biomaterials Inc | United States | Maker | — | 5 | 2018 |
| 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 · +1 | 2 | 2013 |
| Denali R & D Corporation | United States | Maker | AURA Lay · Bonita | 2 | 2009 |
| B.J.M. Laboratories Ltd | Israel | Maker | Biocoat Sealant · Enamel Loc · MultiMatch Flow Chameleon AntiMicrobial Composite · Premier Self-Etching Enamel Sealant · +2 | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA LC Nano Hybrid Composite · IDENTA LC Nano Hybrid Flowable Composite | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Conamco | United States | Maker | Medental | — | — |
| indigodental GmbH | Germany | Maker | — | — | — |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Flowable Composite · PIT & FISSURE SEALANT · Put & Fissure Sealant Light Curing | 23 | 2025 |
| Kettenbach GmbH & Co. KG | Germany | Manufacturer | — | 14 | 2026 |
| Centrix, Inc. | United States | Contract manufacturer | — | 44 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | CosmeSeal · PorcelEtch | 27 | 2024 |
| Pac-Dent Inc. | United States | Contract manufacturer | — | 5 | 2022 |
| NuSmile, Ltd. | United States | Manufacturer | 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 · +2 | 1 | 2015 |
| 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 · +4 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Coating · Dental cement · Pit & FIssure · Sealant · +3 | — | — |
| 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 · +1 | — | — |
| 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 · +1 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Clinpro Syringe · Sonicfill Composite · Vertise Flow | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Material, Tooth shade, Resin | — | — |
| Viarden Lab LLC | United States | Manufacturer for export | PIT AND FISSURE SEALNT VIARDEN LAB, IONGLASS SEALER | — | — |
| 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 | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| 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 | — | — | — |
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 1 May 2026 | K260819 | Any-Com Seal | Mediclus Co., Ltd |
| 8 Aug 2025 | K243254 | Parkell Pit and Fissure Sealant | Parkell, Inc |
| 18 Aug 2023 | K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. |
| 25 Jul 2023 | K230455 | Enamel Coating Resin | Rizhao HuGe Biomaterials Company, Ltd. |
| 8 Nov 2019 | K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. |
| 29 Jul 2019 | K190339 | Helioseal F Plus | Ivoclar Vivadent, AG |
| 5 Jan 2018 | K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation |
| 8 Sep 2017 | K171330 | Nanova Sealant | Nanova Biomaterials Inc |
| 23 May 2017 | K162598 | HAPI Seal | Bisco, Inc. |
| 18 Oct 2016 | K161580 | Premier Sealant | Premier Dental Company Products |
| 9 Mar 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT | Pac-Dent International, Inc. |
| 11 Feb 2014 | K130485 | CONTROL SEAL | Voco GmbH |
| 11 Jun 2013 | K122521 | PREVENT SEAL | ITENA Clinical |
| 21 Mar 2012 | K113818 | EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL | Pulpdent Corporation |
| 23 Sep 2011 | K112517 | ULTRASEAL XT HYDRO | Ultradent Products, Inc. |
| 16 Sep 2011 | K111782 | BEAUTISEALANT | Shofu Inc |
| 31 Mar 2011 | K110058 | BPA-FREE PIT AND FISSURE SEALANT | Novocol Inc. Dba Septodont and Confi-Dental Produc |
| 3 Dec 2010 | K102252 | DMP PIT & FISSURE SEALANT | Dmp, Ltd. |
| 26 Oct 2010 | K103121 | ECO-S | Vericom Co., Ltd. |
| 17 Sep 2010 | K101245 | ULTRASEAL ID | Ultradent Products, Inc. |
| 26 Mar 2010 | K100062 | INFILTRATION KIT | Dmg USA, Inc. |
| 4 Feb 2010 | K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT | Classone Orthodontics, Inc. |
| 3 Sep 2009 | K091632 | SPK SEALANT | 3M Company |
| 22 Jan 2009 | K083473 | CLEAR BRAVO | Denali R & D Corporation |
| 18 Sep 2008 | K081493 | INFILTRATION KIT | Dmg USA, Inc. |
| 5 Jun 2007 | K071158 | AURALAY PIT & FISSURE SEALANT | Denali Corporation |
| 6 Nov 2006 | K062886 | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 | CAO Group, Inc. |
| 4 Oct 2006 | K061997 | PREMIER SELF-ETCHING ENAMEL SEALANT | Premier Dental Products Company |
| 2 Oct 2006 | K062344 | GRANDIO SEAL | Voco GmbH |
| 21 Jul 2006 | K061823 | ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE | Voco GmbH |
| 8 Feb 2006 | K052281 | EMBRACE WETBOND CLEAR SEALANT | Pulpdent Corporation |
| 20 Dec 2005 | K053089 | ASCENT PIT & FISSURE SEALANT | CAO Group, Inc. |
| 28 Jul 2005 | K051224 | BOSWORTH SEAL | Harry J. Bosworth Co. |
| 10 Jun 2005 | K050871 | RIVA PROTECT | Southern Dental Industries, Inc. |
| 11 May 2005 | K050959 | DELTON ILLUMINATING PIT AND FISSURE SEALING | Dentsply International, Inc. |
| 1 Dec 2004 | K042823 | COSMEDENT PIT & FISSURE SEALANT | Cosmedent, Inc. |
| 5 Feb 2004 | K033751 | AEGIS PIT & FISSURE SEALANT WITH ACP | Harry J. Bosworth Co. |
| 4 Sep 2003 | K031811 | PIT & FISSURE SEALANT WITH FLUORIDE | Harry J. Bosworth Co. |
| 29 Jul 2002 | K021842 | ADMIRA SEAL | Voco GmbH |
| 19 Jul 2002 | K021844 | ADMIRA PROTECT | Voco GmbH |
| 12 Apr 2002 | K020287 | DENTITION INTEGRATING MATERIAL | Pulpdent Corporation |
| 1 Nov 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. |
| 16 Oct 2001 | K012542 | REVOTEK LC | GC America Inc. |
| 14 Sep 2001 | K012742 | TEETHMATE F-1 | Kuraray Medical, Inc. |
| 6 Sep 2001 | K011908 | OPTIBOND SOLO PLUS 3 | Kerr Dental Materials Center |
| 16 Aug 2001 | K011491 | HELIOSEAL CLEAR CHROMA | Ivoclar North America, Inc. |
| 7 Aug 2001 | K011822 | PIT AND FISSURE CHEMICAL CURING SEALANT | Rite-Dent Manufacturing Corp. |
| 16 Feb 2000 | K993846 | ULTRASEAL XT PLUS | Ultradent Products, Inc. |
| 22 Oct 1999 | K992519 | NRC NON-RINSE CONDITIONER | Dentsply Intl., Inc. |
| 8 Oct 1999 | K992326 | 3M CLINPRO SEALANT | 3M Company |
| 22 Sep 1999 | K992518 | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply Intl., Inc. |
| 27 Aug 1999 | K992516 | DYRACT SEAL COMPOMER PIT & FISSURE SEALANT | Dentsply Intl., Inc. |
| 20 Aug 1999 | K991909 | DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT | Dentsply Intl., Inc. |
| 26 Jul 1999 | K991902 | LC PIT & FISSURE SEALANT | Bosworth Co. |
| 10 Jun 1999 | K991099 | AMERICAN DENTAL PRODUCTS ETCH-DETECT | American Dental Products, Inc. |
| 14 May 1999 | K990650 | CONSEAL F | Southern Dental Industries, Inc. |
| 3 Mar 1999 | K990306 | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 | Kay See Dental Mfg. Co. |
| 6 Oct 1998 | K982564 | DELTON FS DIRECT DELIVERY SYSTEM | Dentsply Intl., Inc. |
| 25 Nov 1997 | K973541 | MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED | Medental Intl. |
| 27 Mar 1997 | K965091 | TEETHMATE F-1 | Kuraray Company, Ltd. |
| 12 Nov 1996 | K963921 | PULPDENT SEAL-RITE UDMA | Pulpdent Corporation |
| 23 Apr 1996 | K961190 | GLY-ETCH | Centrix, Inc. |
| 8 Mar 1996 | K954867 | IONOSIT SEAL | Foremost Dental Mfg., Inc. |
| 4 Jan 1996 | K954827 | SEALITE FL | Sybron Dental Specialties |
| 30 Oct 1995 | K954701 | AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING | American Dental Products, Inc. |
| 18 Aug 1995 | K952240 | TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION | Jeneric/Pentron, Inc. |
| 3 May 1995 | K951296 | DELTON F PIT & FISSURE SEALANT | Dentsply Intl., Inc. |
| 17 Jan 1995 | K945378 | PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT | Pulpdent Corporation |
| 21 Jan 1994 | K935727 | P&FS PIT AND FISSURE SEALANT | Jedental Co., Inc. |
| 20 Sep 1993 | K932794 | PULPDENT SEAL-RITE LOW VISCOSITY | Pulpdent Corporation |
| 15 Sep 1993 | K932078 | HELIOSEAL F | Ivoclar North America, Inc. |
| 22 Jul 1993 | K932002 | BARITONE C2, MODIFICATION | Confi-Dental Products Co. |
| 22 Jul 1993 | K931869 | ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE | Ultradent Products, Inc. |
| 22 Jul 1993 | K931868 | PRIMADRY PRODUCT LINE | Ultradent Products, Inc. |
| 22 Jul 1993 | K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT | Confi-Dental Products Co. |
| 16 Mar 1993 | K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE | Unicep |
| 23 Dec 1992 | K923895 | QUIKSEAL | Mirage Dental Systems |
| 16 Oct 1992 | K924635 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. |
| 28 Sep 1992 | K921600 | ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE | Ultradent Products, Inc. |
| 28 Sep 1992 | K921599 | ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN | Ultradent Products, Inc. |
| 27 Aug 1992 | K913853 | FISSURE SEALER | Ortho Source |
| 17 Jan 1992 | K915095 | ESTISEAL LC | Heraeus Kulzer, LLC |
| 23 Oct 1991 | K914322 | BARITONE C2 & BARITONE L3 | Confi-Dental Products Co. |
| 23 Oct 1991 | K914319 | PIT AND FISSURE SEALANT PRODUCTS | Confi-Dental Products Co. |
| 10 Jun 1991 | K911287 | PULPDENT SEAL RITE | Pulpdent Corporation |
| 7 May 1991 | K910813 | MET-ETCH | Gresco Products, Inc. |
| 29 Apr 1991 | K905582 | POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND | Milton Hodosh, M.D. |
| 12 Sep 1990 | K902742 | DEGUFILL (TM) WHIT-SEALANT | Degussa AG |
| 20 Jul 1990 | K902022 | SEAL RITE(TM) | Pulpdent Corporation |
| 13 Jul 1990 | K902023 | SEAL RITE PROCEDURE KIT(TM) | Pulpdent Corporation |
| 23 Apr 1990 | K896341 | FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE | Dentsply Intl., Inc. |
| 14 Mar 1990 | K897027 | TEETHMATE-A | Kuraray Company, Ltd. |
| 1 May 1989 | K891140 | OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT | Coe Laboratories, Inc. |
| 29 Mar 1989 | K890494 | FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS | Macrochem Corp. |
| 13 Feb 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | Foremost Dental Mfg., Inc. |
| 29 Feb 1988 | K875091 | ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT | Mission White Dental, Inc. |
| 8 Feb 1988 | K874944 | MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT | Dentsply Intl., Inc. |
| 28 Jan 1988 | K874557 | BISCO PORCELAIN REPAIR KIT | Bisco, Inc. |
| 28 Jan 1988 | K874556 | BISCO PIT AND FISSURE SEALANT | Bisco, Inc. |
| 15 Sep 1987 | K873069 | MODIFIED VISIO-SEAL | Espe GmbH (Us) |
| 2 Mar 1987 | K870579 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. |
| 31 Jul 1986 | K862695 | FLUOR-ETCH GEL ETCHANT | Teledyne, Inc. |
| 31 Jul 1986 | K862660 | PRISMA METAL OPAQUERS | Dentsply Intl., Inc. |
| 23 Jun 1986 | K862284 | SEALITE | Sybron Corp. |
| 11 Apr 1986 | K861245 | ORTHOSOURCE ETCH SYSTEMS | Ortho Source |
| 30 Jan 1986 | K854882 | PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT | Lee Pharmaceuticals |
| 23 Dec 1985 | K854494 | CERAM-ETCH | Gresco Products, Inc. |
| 18 Mar 1985 | K845034 | FOREMOST LITE CURE PIT & FISSURE SEALANT | Foremost Dental Mfg., Inc. |
| 9 Jan 1985 | K844308 | PIT AND FISSURE SEAANTS | Dentsply Intl., Inc. |
| 7 Jan 1985 | K844211 | CONCISE LIGHT CURED WHITE SEALANT | 3M Company |
| 3 Dec 1984 | K844057 | C-22 PIT & FISSURE SEALANT | Pentron Corp. |
| 27 Sep 1984 | K843024 | COMMAND ULTRASEAL PIT & FISSURE SEALANT | Kerr Corporation (Danbury) |
| 7 Sep 1984 | K843098 | APCO FISSURE SEALER & BONDING AGENT | Scientific Pharmaceuticals |
| 26 Jul 1984 | K842392 | DELTON * OPAQUE LIGHT CURING PIT | Johnson & Johnson Professionals, Inc. |
| 30 Jun 1983 | K831380 | DELTON LIGHT CURING PIT & FISSURE | Johnson & Johnson Professionals, Inc. |
| 2 Dec 1981 | K813015 | HELIOSEAL | Vivadent (Usa), Inc. |
| 24 Nov 1981 | K813091 | FISSURE SEALER & BONDING AGENT | Sci-Pharm, Inc. |
| 25 Sep 1981 | K812549 | BEAUSEAL | Sci-Pharm, Inc. |
| 26 Jun 1981 | K811624 | VISIO-SEAL | Espe-Premier Sales Co. |
| 29 Apr 1981 | K810950 | VISIO-SEAL | Espe Dental Products |
| 24 Nov 1980 | K802682 | CONTACT SEAL | Vivadent (Usa), Inc. |
| 12 Nov 1980 | K802562 | PRISMA SEAL | Dentsply Intl., Inc. |
| 9 Jun 1980 | K801274 | S.S. WHITE-PENNWALT PRELUDE PIT SEALANT | Pennwalt Corp. |
| 10 Apr 1980 | K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER | American Dental Research |
| 3 Aug 1979 | K790935 | DELTON* PIT AND FISSURE SEALENT | Johnson & Johnson Professionals, Inc. |
| 6 Jul 1979 | K790788 | FISSURE SEALER AND BONDING AGENT | Scientific Pharmaceuticals |
| 15 Jun 1979 | K790596 | ENAMEL BOND SYSTEM | Wallace A. Erickson & Co. |
| 26 Aug 1977 | K771402 | NUVA-COTE (MODIFICATION TO) | L.D. Caulk Co. |
| 2 Aug 1977 | K771327 | UVIOFIL | Espe GmbH (Us) |
| 23 Aug 1976 | K760418 | 9075 | Lee Pharmaceuticals |
| 23 Aug 1976 | K760405 | SEALANT, NEW FILLED | L.D. Caulk Co. |
Official records: FDA product classification for EBC · 21 CFR 872.3765.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026