FDA 510(k) Applications for Medical Device Product Code "LBH"
(Varnish, Cavity)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K151302 | 3m Company | Clinpro Varnish | 09/18/2015 |
| K090519 | 3M COMPANY | VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 | 04/15/2009 |
| K231338 | 3M ESPE Dental Products | 3MÖ ClinproÖ Clear 2.1% Sodium Fluoride Treatment | 05/10/2023 |
| K092141 | 3M ESPE DENTAL PRODUCTS | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | 03/10/2010 |
| K070289 | ACQUAMED TECHNOLOGIES, INC. | ACQUASEAL BENZ | 05/04/2007 |
| K082071 | ADPHARMA, INC. | ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT | 10/02/2008 |
| K990779 | ADVANTAGE DENTAL PRODUCTS, INC. | HEMASEAL & CIDE | 11/17/1999 |
| K182917 | Bisco, Inc | FluoroCal | 11/18/2019 |
| K123653 | BISCO, INC. | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) | 06/03/2013 |
| K070070 | CAO GROUP, INC. | ASCENT DENTAL CLEANSER | 05/25/2007 |
| K100540 | CAO GROUP, INC. | ASCENT F-COAT MODEL: 006-00097 | 09/23/2010 |
| K103160 | CAO GROUP, INC. | NUPRO MODEL 13016901 | 01/06/2011 |
| K021131 | CENTRIX, INC. | CHLORAPREP | 09/26/2002 |
| K992629 | CENTRIX, INC. | D/SENSE II (GREEN-OR) DENTIN DESENSITIZER | 10/22/1999 |
| K981972 | CENTRIX, INC. | GREEN-OR DENTIN DESENSITIZER | 12/07/1998 |
| K120176 | CENTRIX, INC. | SENZZZZZ AWAY | 07/25/2012 |
| K023671 | CHX TECHNOLOGIES, INC. | AQUEOUS ACRYLIC DISPERSION 28% W/W | 11/25/2002 |
| K103461 | COLGATE-PALMOLIVE CO. | COLGATE DESENSITIZING DENTAL CREAM | 09/13/2011 |
| K140481 | COLGATE-PALMOLIVE COMPANY | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH | 06/05/2014 |
| K073061 | COLL PARTNERS LTD. | THE PROXIVENT KIT | 02/29/2008 |
| K052263 | COSMEDENT, INC. | MULTIPLE (TOOTH DESENSITIZER) | 12/16/2005 |
| K124025 | DENTAL TECHNOLOGIES, INC. | ALPHA-PRO WHITE VARNISH | 09/18/2013 |
| K122331 | DENTSPLY INTERNATIONAL, INC. | CAVITY VARNISH | 10/15/2012 |
| K072342 | DENTSPLY INTERNATIONAL, INC. | SULTAN TOOTH ROOT DESENSITIZER | 10/03/2007 |
| K031932 | DENTSPLY INTL. | FLUORIDE VARNISH | 09/15/2003 |
| K021805 | DENTSPLY INTL. | SEAL & PROTECT PROTECTIVE SEALANT | 08/19/2002 |
| K992822 | DENTSPLY INTL. | SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE | 11/17/1999 |
| K073117 | DENTSPLY INTL., INC. | DENTIN DESENSITIZER AGENT | 12/19/2007 |
| K082198 | DENTSPLY INTL., INC. | DURASHIELD PLUS | 10/29/2008 |
| K062176 | DISCUS DENTAL INC. | RELIEF ACP ORAL CARE GEL | 01/10/2007 |
| K200077 | Dr. Collins, Inc. | BioMin Restore Plus | 11/06/2020 |
| K181965 | Dr. Collins, Inc. | Restore Toothpaste | 06/13/2019 |
| K131376 | ELEVATE ORAL CARE | SMARTCOAT 2.5% NAF VARNISH | 08/27/2013 |
| K102808 | GC AMERICA INC. | MI VARNISH | 12/22/2010 |
| K222891 | Guangzhou Beogene Biotech Co., Ltd | Dental Desensitizer | 05/25/2023 |
| K093575 | HERAEUS KULZER, LLC | GLUMA DESENSITIZER POWER GEL | 03/05/2010 |
| K131487 | IVOCLAR VIVADENT AG | FLUOR PROTECTOR S | 10/08/2014 |
| K191453 | Ivoclar Vivadent, AG | Cervitec F | 02/11/2020 |
| K072338 | IVOCLAR VIVADENT, INC. | CERVITEC PLUS | 09/21/2007 |
| K030922 | IVOCLAR VIVADENT, INC. | VIVASENS | 10/17/2003 |
| K010957 | JENERIC/PENTRON, INC. | QUELL DESENSITIZER | 06/25/2001 |
| K143155 | Johnson & Johnson Healthcare Products, Division of McNeil-PP | LISTERINE Sensitivity Defense Mouthrinse | 01/29/2015 |
| K230333 | Kettenbach GmbH & Co. KG | 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) | 07/24/2023 |
| K200614 | Largent Health, LLC | FiteBac Antimicrobial Cavity Cleanser | 06/25/2020 |
| K190271 | Largent Health, LLC | FiteBac Cavity Cleanser | 01/23/2020 |
| K973919 | MEDENTAL INTL. | CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) | 12/16/1997 |
| K040098 | MEDICAL PRODUCTS LABORATORIES, INC. | VARNISHAMERICA | 02/04/2004 |
| K140349 | NANOVA BIOMATERIALS, INC. | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | 09/22/2014 |
| K033295 | NOVAMIN TECHNOLOGY, INC. | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN | 10/28/2003 |
| K061359 | NOVAMIN TECHNOLOGY, INC. | DENSHIELD TREATMENT FOR SENSITIVE TEETH | 10/18/2006 |
| K080228 | NOVAMIN TECHNOLOGY, INC. | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH | 03/27/2008 |
| K040858 | NOVAMIN TECHNOLOGY, INC. | ORALIEF THERAPY FOR SENSITIVE TEETH | 09/02/2004 |
| K040473 | NOVAMIN TECHNOLOGY, INC. | ORAVIVE TOOTH REVITALIZING PASTE | 03/10/2004 |
| K071267 | NOVAMIN TECHNOLOGY, INC. | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN | 05/18/2007 |
| K003482 | ORTEK THERAPEUTICS, INC. | PROCLUDE-SENSITIVE | 02/01/2001 |
| K141422 | PAC-DENT INTERNATIONAL, INC. | PROFLUORO FLUORIDE VARNISH | 09/30/2014 |
| K030488 | PASCAL CO., INC. | FLUORILAQ | 05/02/2003 |
| K090597 | PASCAL CO., INC. | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | 03/16/2009 |
| K961893 | PHARMASCIENCE, INC. | DURAFLOR | 08/14/1996 |
| K120109 | PHOENIX DENTAL, INC. | SUPER SEAL TOOTH DESENSITIZER | 03/07/2012 |
| K062683 | PREMIER DENTAL PRODUCTS CO. | ENAMEL PRO VARNISH | 11/21/2006 |
| K140350 | PREVENTIVE TECHNOLOGIES, INC. | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | 12/12/2014 |
| K974202 | PULPDENT CORP. | PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS | 03/19/1998 |
| K994182 | PULPDENT CORP. | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE | 02/23/2000 |
| K994181 | PULPDENT CORP. | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE | 02/29/2000 |
| K994180 | PULPDENT CORP. | PULPDENT CAVITY PREPARATION III | 03/02/2000 |
| K013411 | PULPDENT CORP. | PULPDENT CAVITY PREPARATION IV | 12/12/2001 |
| K974398 | PULPDENT CORP. | PULPDENT CAVITY VARNISH | 02/18/1998 |
| K112946 | PULPDENT CORPORATION | ACTIV VARNISH | 12/09/2011 |
| K100503 | PULPDENT CORPORATION | PULPDENT COPAL VARNISH WITH FLUORIDE | 05/12/2010 |
| K093620 | PULPDENT CORPORATION | PULPDENT FLUORIDE VARNISH | 03/10/2010 |
| K082594 | REMEDENT NV | REMESENSE | 03/19/2009 |
| K010255 | RITE-DENT MANUFACTURING CORP. | CAVITY VARNISH | 04/20/2001 |
| K113146 | ROSS HEALTHCARE INC. | PCXX VARNISH | 01/23/2012 |
| K220419 | Sangi Co, Ltd | Apapro Desensitizer | 02/16/2022 |
| K192381 | Scientific Pharmaceuticals | 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 | 02/18/2020 |
| K983305 | SCIENTIFIC PHARMACEUTICALS, INC. | SCI-PHARM DESENSITIZING VARNISH | 12/17/1998 |
| K982915 | SCIENTIFIC PHARMACEUTICALS, INC. | SCI-PHARM DFV VARNISH | 02/12/1999 |
| K122908 | SHOFU DENTAL CORPORATION | PRG BARRIER COAT | 04/26/2013 |
| K002581 | SULTAN DENTAL PRODUCTS, LTD. | DURAGARD SODIUM FLUORIDE VARNISH | 10/20/2000 |
| K050486 | SUNSTAR BUTLER | PROTECT TOOTH DESENSITIZER | 06/07/2005 |
| K122708 | SYLPHAR N.V. | REMESENSE FOR SENSITIVE TEETH | 01/14/2013 |
| K132426 | SYLPHAR N.V. | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS | 02/14/2014 |
| K100172 | TOKUYAMA DENTAL CORPORATION | TOKUYAMA SHIELD FORCE | 10/21/2010 |
| K132109 | ULTRADENT PRODUCTS INC. / ORATECH LLC | ENAMELAST | 11/01/2013 |
| K080249 | ULTRADENT PRODUCTS, INC. | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | 02/08/2008 |
| K051750 | ULTRADENT PRODUCTS, INC. | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 | 09/19/2005 |
| K963979 | ULTRADENT PRODUCTS, INC. | ULTRADENT UNIVERSAL DENTIN SEALANT | 12/12/1996 |
| K061438 | ULTRADENT PRODUCTS, INC. | ULTRAEZ DESENSITIZING GEL | 06/12/2007 |
| K160377 | Vericom Co., Ltd. | V-varnish Premium | 12/02/2016 |
| K083036 | VOCO GMBH | VOCO PROFLUORID L | 01/12/2009 |
| K080814 | VOCO GMBH | VOCO PROFLUORID VARNISH | 07/24/2008 |
| K955521 | WALLACE A. ERICKSON & CO. | ALPHA-DENT COPAL CAVITY VARNISH | 01/24/1996 |
| K153334 | YOUNG DENTAL MANUFACTURING CO 1, LLC. | Oral-B 5% Sodium Fluoride Varnish | 05/20/2016 |
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