FDA 510(k) Applications for Medical Device Product Code "EBC"
(Sealant, Pit And Fissure, And Conditioner)

FDA 510(k) Number Applicant Device Name Decision Date
K992326 3M COMPANY 3M CLINPRO SEALANT 10/08/1999
K844211 3M COMPANY CONCISE LIGHT CURED WHITE SEALANT 01/07/1985
K091632 3M COMPANY SPK SEALANT 09/03/2009
K991099 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS ETCH-DETECT 06/10/1999
K954701 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING 10/30/1995
K800391 AMERICAN DENTAL RESEARCH PAINT-ON-RESTORATIVE W/FISSURE SEALER 04/10/1980
K874556 BISCO, INC. BISCO PIT AND FISSURE SEALANT 01/28/1988
K874557 BISCO, INC. BISCO PORCELAIN REPAIR KIT 01/28/1988
K162598 BISCO, INC. HAPI Seal 05/23/2017
K991902 BOSWORTH CO. LC PIT & FISSURE SEALANT 07/26/1999
K053089 CAO GROUP, INC. ASCENT PIT & FISSURE SEALANT 12/20/2005
K062886 CAO GROUP, INC. ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 11/06/2006
K961190 CENTRIX, INC. GLY-ETCH 04/23/1996
K093059 CLASSONE ORTHODONTICS, INC. SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT 02/04/2010
K891140 COE LABORATORIES, INC. OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT 05/01/1989
K914322 CONFI-DENTAL PRODUCTS CO. BARITONE C2 & BARITONE L3 10/23/1991
K932002 CONFI-DENTAL PRODUCTS CO. BARITONE C2, MODIFICATION 07/22/1993
K914319 CONFI-DENTAL PRODUCTS CO. PIT AND FISSURE SEALANT PRODUCTS 10/23/1991
K931857 CONFI-DENTAL PRODUCTS CO. SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT 07/22/1993
K042823 COSMEDENT, INC. COSMEDENT PIT & FISSURE SEALANT 12/01/2004
K902742 DEGUSSA AG DEGUFILL (TM) WHIT-SEALANT 09/12/1990
K071158 DENALI CORPORATION AURALAY PIT & FISSURE SEALANT 06/05/2007
K083473 DENALI R&D CORPORATION CLEAR BRAVO 01/22/2009
K050959 DENTSPLY INTERNATIONAL DELTON ILLUMINATING PIT AND FISSURE SEALING 05/11/2005
K862660 DENTSPLY INTL. "PRISMA METAL OPAQUERS" 07/31/1986
K951296 DENTSPLY INTL. DELTON F PIT & FISSURE SEALANT 05/03/1995
K982564 DENTSPLY INTL. DELTON FS DIRECT DELIVERY SYSTEM 10/06/1998
K991909 DENTSPLY INTL. DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT 08/20/1999
K992516 DENTSPLY INTL. DYRACT SEAL COMPOMER PIT & FISSURE SEALANT 08/27/1999
K896341 DENTSPLY INTL. FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE 04/23/1990
K874944 DENTSPLY INTL. MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT 02/08/1988
K992519 DENTSPLY INTL. NRC NON-RINSE CONDITIONER 10/22/1999
K844308 DENTSPLY INTL. PIT AND FISSURE SEAANTS 01/09/1985
K992518 DENTSPLY INTL. PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM 09/22/1999
K802562 DENTSPLY INTL. PRISMA SEAL 11/12/1980
K100062 DMG USA, INC. INFILTRATION KIT 03/26/2010
K081493 DMG USA, INC. INFILTRATION KIT 09/18/2008
K102252 DMP LTD DMP PIT & FISSURE SEALANT 12/03/2010
K810950 ESPE DENTAL PRODUCTS VISIO-SEAL 04/29/1981
K873069 ESPE GMBH (US) MODIFIED VISIO-SEAL 09/15/1987
K771327 ESPE GMBH (US) UVIOFIL 08/02/1977
K811624 ESPE-PREMIER SALES CO. VISIO-SEAL 06/26/1981
K845034 FOREMOST DENTAL MFG., INC. FOREMOST LITE CURE PIT & FISSURE SEALANT 03/18/1985
K954867 FOREMOST DENTAL MFG., INC. IONOSIT SEAL 03/08/1996
K890464 FOREMOST DENTAL MFG., INC. ZENITH 40% PHOSPHORIC ACID GEL 02/13/1989
K012542 GC AMERICA, INC. REVOTEK LC 10/16/2001
K854494 GRESCO PRODUCTS, INC. CERAM-ETCH 12/23/1985
K910813 GRESCO PRODUCTS, INC. MET-ETCH 05/07/1991
K033751 HARRY J. BOSWORTH CO. AEGIS PIT & FISSURE SEALANT WITH ACP 02/05/2004
K051224 HARRY J. BOSWORTH CO. BOSWORTH SEAL 07/28/2005
K031811 HARRY J. BOSWORTH CO. PIT & FISSURE SEALANT WITH FLUORIDE 09/04/2003
K915095 HERAEUS KULZER, INC. ESTISEAL LC 01/17/1992
K091635 HERAEUS KULZER, LLC VENUS DIAMOND FLOW 09/03/2009
K122521 ITENA CLINICAL PREVENT SEAL 06/11/2013
K011491 IVOCLAR NORTH AMERICA, INC. HELIOSEAL CLEAR CHROMA 08/16/2001
K932078 IVOCLAR NORTH AMERICA, INC. HELIOSEAL F 09/15/1993
K935727 JEDENTAL CO., INC. P&FS PIT AND FISSURE SEALANT 01/21/1994
K952240 JENERIC/PENTRON, INC. TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION 08/18/1995
K842392 JOHNSON & JOHNSON PROFESSIONALS, INC. DELTON * OPAQUE LIGHT CURING PIT 07/26/1984
K831380 JOHNSON & JOHNSON PROFESSIONALS, INC. DELTON LIGHT CURING PIT & FISSURE 06/30/1983
K790935 JOHNSON & JOHNSON PROFESSIONALS, INC. DELTON* PIT AND FISSURE SEALENT 08/03/1979
K990306 KAY SEE DENTAL MFG. CO. HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 03/03/1999
K843024 KERR CORPORATION (DANBURY) COMMAND ULTRASEAL PIT & FISSURE SEALANT 09/27/1984
K011908 KERR DENTAL MATERIALS CENTER OPTIBOND SOLO PLUS 3 09/06/2001
K897027 KURARAY CO. TEETHMATE-A 03/14/1990
K965091 KURARAY COMPANY, LTD. TEETHMATE F-1 03/27/1997
K012742 KURARAY MEDICAL INC. TEETHMATE F-1 09/14/2001
K771402 L.D. CAULK CO. NUVA-COTE (MODIFICATION TO) 08/26/1977
K760405 L.D. CAULK CO. SEALANT, NEW FILLED 08/23/1976
K760418 LEE PHARMACEUTICALS 9075 08/23/1976
K854882 LEE PHARMACEUTICALS PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT 01/30/1986
K890494 MACROCHEM CORP. FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFS 03/29/1989
K973541 MEDENTAL INTL. MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED 11/25/1997
K905582 MILTON HODOSH, M.D. POTASSIUM NITRATE COMPOSITE RESTORATION PIT AND 04/29/1991
K923895 MIRAGE DENTAL SYSTEMS QUIKSEAL 12/23/1992
K875091 MISSION WHITE DENTAL, INC. ORALIN TLC LIGHT CURED PIT AND FISSURE SEALANT 02/29/1988
K171330 Nanova Biomaterials Inc Nanova Sealant 09/08/2017
K110058 NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC BPA-FREE PIT AND FISSURE SEALANT 03/31/2011
K913853 ORTHO SOURCE FISSURE SEALER 08/27/1992
K861245 ORTHO SOURCE ORTHOSOURCE ETCH SYSTEMS 04/11/1986
K141717 PAC-DENT INTERNATIONAL, INC. PACSEAL PIT & FISSURE SEALANT 03/09/2015
K801274 PENNWALT CORP. S.S. WHITE-PENNWALT PRELUDE PIT SEALANT 06/09/1980
K844057 PENTRON CORP. C-22 PIT & FISSURE SEALANT 12/03/1984
K161580 PREMIER DENTAL COMPANY PRODUCTS Premier Sealant 10/18/2016
K061997 PREMIER DENTAL PRODUCTS CO. PREMIER SELF-ETCHING ENAMEL SEALANT 10/04/2006
K012761 PRIME DENTAL MANUFACTURING, INC. PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT 11/01/2001
K945378 PULPDENT CORP. PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT 01/17/1995
K911287 PULPDENT CORP. PULPDENT SEAL RITE 06/10/1991
K932794 PULPDENT CORP. PULPDENT SEAL-RITE LOW VISCOSITY 09/20/1993
K963921 PULPDENT CORP. PULPDENT SEAL-RITE UDMA 11/12/1996
K902023 PULPDENT CORP. SEAL RITE PROCEDURE KIT(TM) 07/13/1990
K902022 PULPDENT CORP. SEAL RITE(TM) 07/20/1990
K020287 PULPDENT CORPORATION DENTITION INTEGRATING MATERIAL 04/12/2002
K052281 PULPDENT CORPORATION EMBRACE WETBOND CLEAR SEALANT 02/08/2006
K113818 PULPDENT CORPORATION EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL 03/21/2012
K172169 Pulpdent Corporation Pulpdent (Activa) Pit and Fissure Sealant with MCP 01/05/2018
K011822 RITE-DENT MANUFACTURING CORP. PIT AND FISSURE CHEMICAL CURING SEALANT 08/07/2001
K812549 SCI-PHARM, INC. "BEAUSEAL" 09/25/1981
K813091 SCI-PHARM, INC. FISSURE SEALER & BONDING AGENT 11/24/1981
K843098 SCIENTIFIC PHARMACEUTICALS, INC. APCO FISSURE SEALER & BONDING AGENT 09/07/1984
K790788 SCIENTIFIC PHARMACEUTICALS, INC. FISSURE SEALER AND BONDING AGENT 07/06/1979
K111782 SHOFU DENTAL CORPORATION BEAUTISEALANT 09/16/2011
K990650 SOUTHERN DENTAL INDUSTRIES, INC. CONSEAL F 05/14/1999
K050871 SOUTHERN DENTAL INDUSTRIES, INC. RIVA PROTECT 06/10/2005
K862284 SYBRON CORP. SEALITE 06/23/1986
K954827 SYBRON DENTAL SPECIALTIES, INC. SEALITE FL 01/04/1996
K862695 TELEDYNE, INC. FLUOR-ETCH GEL ETCHANT 07/31/1986
K931868 ULTRADENT PRODUCTS, INC. PRIMADRY PRODUCT LINE 07/22/1993
K921600 ULTRADENT PRODUCTS, INC. ULTRADENT PROD LI CURED PIT/FISSURE SEAL PROD LINE 09/28/1992
K921599 ULTRADENT PRODUCTS, INC. ULTRADENT PRODUCT DENTIN CONDITION & SEAL PROD LIN 09/28/1992
K101245 ULTRADENT PRODUCTS, INC. ULTRASEAL ID 09/17/2010
K112517 ULTRADENT PRODUCTS, INC. ULTRASEAL XT HYDRO 09/23/2011
K931869 ULTRADENT PRODUCTS, INC. ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE 07/22/1993
K993846 ULTRADENT PRODUCTS, INC. ULTRASEAL XT PLUS 02/16/2000
K924824 UNICEP MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE 03/16/1993
K103121 VERICOM CO., LTD. ECO-S 10/26/2010
K802682 VIVADENT (USA), INC. CONTACT SEAL 11/24/1980
K813015 VIVADENT (USA), INC. HELIOSEAL 12/02/1981
K021844 VOCO GMBH ADMIRA PROTECT 07/19/2002
K061823 VOCO GMBH ADMIRA PROTECT/ADMIRA PROTECT SINGLE DOSE 07/21/2006
K021842 VOCO GMBH ADMIRA SEAL 07/29/2002
K130485 VOCO GMBH CONTROL SEAL 02/11/2014
K062344 VOCO GMBH GRANDIO SEAL 10/02/2006
K870579 WALLACE A. ERICKSON & CO. ALPHA-DENT PIT AND FISSURE SEALANT 03/02/1987
K924635 WALLACE A. ERICKSON & CO. ALPHA-DENT PIT AND FISSURE SEALANT 10/16/1992
K790596 WALLACE A. ERICKSON & CO. ENAMEL BOND SYSTEM 06/15/1979


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