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
K092141 3M ESPE DENTAL PRODUCTS VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH 03/10/2010
K070289 ACQUAMED TECHNOLOGIES, INC. ACQUASEAL BENZ 05/04/2007
K760982 ADP INTL., INC. DENTAL VARNISH 11/15/1976
K082071 ADPHARMA, INC. ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT 10/02/2008
K990779 ADVANTAGE DENTAL PRODUCTS, INC. HEMASEAL & CIDE 11/17/1999
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
K832497 DEN-MAT CORP. CAVITY CLEANSER 10/04/1983
K864050 DENTAL DIMENSIONS SUPPLY CO. TUBULICID BLUE LABEL 12/05/1986
K864051 DENTAL DIMENSIONS SUPPLY CO. TUBULICID RED LABEL 12/10/1986
K864052 DENTAL DIMENSIONS SUPPLY CO. TUBULITEC PRIMER 12/05/1986
K124025 DENTAL TECHNOLOGIES, INC. ALPHA-PRO WHITE VARNISH 09/18/2013
K851052 DENTAL THERAPEUTICS AB TUBULITEC PRIMER 07/31/1985
K122331 DENTSPLY INTERNATIONAL, INC. CAVITY VARNISH 10/15/2012
K072342 DENTSPLY INTERNATIONAL, INC. SULTAN TOOTH ROOT DESENSITIZER 10/03/2007
K810913 DENTSPLY INTL. CAVITY VARNISH 09/21/1981
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
K181965 Dr. Collins, Inc. Restore Toothpaste 06/13/2019
K833701 E.I. DUPONT DE NEMOURS & CO., INC. ACA THYROXINE ANALYTICAL TEST PACK 01/13/1984
K131376 ELEVATE ORAL CARE SMARTCOAT 2.5% NAF VARNISH 08/27/2013
K880741 ESPE GMBH (US) ESPE VARNISH 07/01/1988
K102808 GC AMERICA INC. MI VARNISH 12/22/2010
K933505 HARRY J. BOSWORTH CO. BOSWORTH COPALIONER 01/07/1994
K881026 HARRY J. BOSWORTH CO. CONTAC, A DENTIN SEALANT 06/01/1988
K093575 HERAEUS KULZER, LLC GLUMA DESENSITIZER POWER GEL 03/05/2010
K945794 INPHARMA DURAPHAT 07/26/1995
K901915 IVOCLAR NORTH AMERICA, INC. DENTIN PROTECTOR 06/27/1990
K946032 IVOCLAR NORTH AMERICA, INC. FLUOR PROTECTOR 03/07/1995
K131487 IVOCLAR VIVADENT AG FLUOR PROTECTOR S 10/08/2014
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
K944934 KNOWELL THERAPEUTIC TECHNOLOGIES,INC. POLYURETHANE SOLUTION 29% W/W 12/09/1994
K801047 MAY-PELL CHEMICAL DEVELOPMENT CO. PLY LESIVE 05/20/1980
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
K931096 PHARMASCIENCE, INC. DURAFLOR 05/27/1993
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
K901049 PULPDENT CORP. COPAL VARNISH 05/29/1990
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
K812550 SCI-PHARM, INC. "BEAUCAV" 09/25/1981
K812548 SCI-PHARM, INC. "COBEAU" 09/25/1981
K800438 SCIENTIFIC PHARMACEUTICALS, INC. DENTAL CAVITY VARNISH, CONCENTRATED 03/12/1980
K860633 SCIENTIFIC PHARMACEUTICALS, INC. FLUOROSEAL, DENTIN SEALER AND CAVITY LINER 04/11/1986
K983305 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM DESENSITIZING VARNISH 12/17/1998
K982915 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM DFV VARNISH 02/12/1999
K802926 SCIENTIFIC PHARMACEUTICALS, INC. SCI-PHARM UNIVERSAL CAVITY VARNISH 12/19/1980
K852756 SCIENTIFIC PHARMACEUTICALS, INC. TELEDYNE GETZ BARRIER-DENTIN SEALER 07/31/1985
K852755 SCIENTIFIC PHARMACEUTICALS, INC. UNIVAR UNIVERSAL DENTIN VARNISH 09/23/1985
K900946 SCIENTIFIC PHARMACEUTICALS, INC. UNIVERSUM 05/25/1990
K760660 SEPTODONT, INC. HYDROL 09/27/1976
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
K851030 TEMREX CORP. TEMREX-DENTIN VARNISH 06/20/1985
K100172 TOKUYAMA DENTAL CORPORATION TOKUYAMA SHIELD FORCE 10/21/2010
K132109 ULTRADENT PRODUCTS INC. / ORATECH LLC ENAMELAST 11/01/2013
K925375 ULTRADENT PRODUCTS, INC. CONSEPSIS SCRUB 07/22/1993
K924982 ULTRADENT PRODUCTS, INC. CONSEPSIS(TM) 07/08/1993
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
K953167 ULTRADENT PRODUCTS, INC. ULTRACID DISINFECTING SOLOUTION 09/08/1995
K953168 ULTRADENT PRODUCTS, INC. ULTRACID F DISINFECTING SOLUTION 09/08/1995
K963979 ULTRADENT PRODUCTS, INC. ULTRADENT UNIVERSAL DENTIN SEALANT 12/12/1996
K061438 ULTRADENT PRODUCTS, INC. ULTRAEZ DESENSITIZING GEL 06/12/2007
K924827 UNICEP MICRODOSE POTASSIUM OXYLATE 03/05/1993
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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