FDA 510(k) Applications for Medical Device Product Code "KLE"
(Agent, Tooth Bonding, Resin)

FDA 510(k) Number Applicant Device Name Decision Date
K962785 3M COMPANY 3M DENT SYSTEM 08/12/1996
K920424 3M COMPANY SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM 03/20/1992
K813180 3M COMPANY SCOTCHBOND DENTAL ADHESIVE 01/12/1982
K942493 3M COMPANY SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM 07/05/1994
K011167 3M COMPANY XSE 05/17/2001
K110302 3M ESPE AG ADHESIVE EXL-759 05/19/2011
K020946 3M ESPE AG DENTAL PRODUCTS ADPER PROMPT 04/04/2002
K060684 3M ESPE AG DENTAL PRODUCTS ADPER PROMPT, ADPER PROMPT L-POP 04/24/2006
K033974 3M ESPE AG DENTAL PRODUCTS HERMES BOND 02/06/2004
K043043 3M ESPE AG DENTAL PRODUCTS HERMES BOND 2 01/10/2005
K071260 3M ESPE AG DENTAL PRODUCTS HERMES BOND 3 07/17/2007
K040857 3M ESPE AG DENTAL PRODUCTS MODIFICATION TO ADPER PROMPT 05/10/2004
K071131 3M ESPE AG DENTAL PRODUCTS UNO 07/25/2007
K070956 3M ESPE DENTAL PRODUCTS SEA2 SELF ETCH ADHESIVE 05/22/2007
K022973 AB ARDENT ADHESIVE 14 11/22/2002
K973185 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE 11/14/1997
K964133 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE 01/09/1997
K093014 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS SE BONDEASY 04/16/2010
K954133 AMERICAN DENTAL PRODUCTS, INC. AMERICAN DENTAL PRODUCTS WETTING AGENT & DESENSITIZER 10/30/1995
K800390 AMERICAN DENTAL RESEARCH ANT. & POST. RESTORATIVE POWDER LIQ. 04/10/1980
K800389 AMERICAN DENTAL RESEARCH ANTERIOR & POST. RESTORATIVE PASTE SYS. 04/10/1980
K172953 American Orthodontics Acid Etchant 02/06/2018
K181910 American Orthodontics BracePaste MTP Light Cure Primer 10/15/2018
K132923 ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA FUSION SINGLE LINK 01/03/2014
K161077 Apex Dental Materials, Inc RnD TE and RnD SE 03/17/2017
K131043 APEX DENTAL MATERIALS, INC. APEX UNIVERSAL ADHESIVE 09/10/2013
K120620 APEX DENTAL MATERIALS, INC. CLEAN AND BOOST 05/31/2012
K053103 APEX DENTAL MATERIALS, INC. INTERFACE 02/01/2006
K020570 APEX DENTAL MATERIALS, INC. SIMPLICITY 04/24/2002
K061981 APEX DENTAL MATERIALS, INC. SURPASS 07/31/2006
K010547 APEX DENTAL MATERIALS, INC. VERTEX SEALAND L/C ORTHODONTIC SEALANT 08/16/2001
K131049 APEX DENTAL MATERIALS, INC. ZRP 08/27/2013
K992838 BIOMAT SCIENCES, INC. ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE 11/15/1999
K063780 BISCO, INC. ACE BOND SE 01/19/2007
K910628 BISCO, INC. ALL BOND LINER-F 03/29/1991
K910860 BISCO, INC. ALL-BOND 2 04/29/1991
K897020 BISCO, INC. ALL-BOND DENTIN BONDING SYSTEM 03/14/1990
K131734 BISCO, INC. ALL-BOND UNIVERSAL SC (NOT FINALIZED) 04/11/2014
K161051 Bisco, Inc. All-Bond Universal w/BAC (not finalized) 09/09/2016
K932379 BISCO, INC. ALL-BOND(R) JR. 07/22/1993
K102844 BISCO, INC. ALL-BOUND 3 10/29/2010
K101485 BISCO, INC. ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E 08/26/2010
K050647 BISCO, INC. ALL-IN-ONE 04/20/2005
K934596 BISCO, INC. BISCO DUO LINK D/C LUTING COMPOSITE 01/26/1994
K923842 BISCO, INC. BISCO UNIVERSAL BOND-3 09/29/1992
K964000 BISCO, INC. BISFIL 2B 11/05/1996
K112118 BISCO, INC. DREAMBOND 11/17/2011
K945604 BISCO, INC. ECLIPTOMER 01/03/1995
K091705 BISCO, INC. PRIMER PLUS 08/28/2009
K013519 BISCO, INC. SIMPLE 01/17/2002
K961822 BISCO, INC. WET-PREP 06/11/1996
K884533 BLOCK DRUG COMPANY, INC. SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM 04/12/1989
K092616 CAO GROUP, INC. ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 10/21/2009
K091300 CAO GROUP, INC. ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 07/23/2009
K070413 CAO GROUP, INC. ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 04/26/2007
K782080 CAULK CO., DIV. DENTSPLY VENEER SYSTEM, MOSTIQUE LAMINATE 01/26/1979
K983545 CAVEX HOLLAND B.V. QUADRANT UNIBOND 11/18/1998
K042806 CAVEX HOLLAND B.V. QUADRANT UNIT-1-BOND 11/24/2004
K955279 CENTRIX, INC. D-SENSE 12/28/1995
K973285 CENTRIX, INC. D/SENSE-T 02/25/1998
K964735 CENTRIX, INC. DENTINSENSE 02/05/1997
K965138 CENTRIX, INC. DENTINSENSE B/C 02/14/1997
K971121 CENTRIX, INC. ENCORE BOND 06/27/1997
K884137 CHAMELEON DENTAL PRODUCTS, INC. MIRAGE BOND 12/07/1988
K973002 CHENG & ASSOC., INC. HURRISEAL DENTIN DESENSITIZER 03/23/1998
K885010 COE LABORATORIES, INC. TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING 02/13/1989
K152243 Coltene/Whaledent AG One Coat 7 Universal 12/09/2015
K922615 COLTENE/WHALEDENT INC. COLTENE A.R.T. BOND 08/03/1992
K974906 COLTENE/WHALEDENT INC. ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM 03/24/1998
K033760 COLTENE/WHALEDENT INC. ONE COAT SE BOND 01/23/2004
K955328 CONFI-DENTAL PRODUCTS CO. CONFI-BOND 03/28/1996
K030743 CONFI-DENTAL PRODUCTS CO. ETCHANT 40% 05/09/2003
K894994 COSMEDENT, INC. DENTIN BONDING SYSTEM 10/24/1989
K052501 COSMEDENT, INC. MULTIPLE RESIN TOOTH BONDING AGENT 10/21/2005
K953504 DANVILLE ENGINEERING, INC. MICROPRIME 10/03/1995
K040952 DANVILLE MATERIALS, INC. PRELUDE 06/29/2004
K090106 DANVILLE MATERIALS, INC. PRELUDE ONE 03/31/2009
K111876 DANVILLE MATERIALS, INC. Z BOND, PRELUDE ONE 09/21/2011
K901871 DEGUSSA AG DEGUFILL (R) ADHESIVE 08/06/1990
K901870 DEGUSSA AG DEGUFILL (R) BOND 08/06/1990
K902744 DEGUSSA AG DEGUFILL (TM) BOND 08/15/1990
K041680 DEL PHARMACEUTICALS, INC. ORAJEL ADVANCED TOOTH DESENSITIZER 11/10/2004
K801216 DEN-MAT CORP. DEN-MAT DENTIN BONDING AGENT 05/28/1980
K860971 DEN-MAT CORP. DEN-MAT GOLD LINK (FORMERLY DEN-MAT METAL OPAQUER) 03/25/1986
K140537 DEN-MAT HOLDINGS, LLC TENURE4G 08/20/2014
K962277 DENT ZAR, INC. SELF CURE BONDING AGENT 07/03/1996
K050386 DENTSPLY INTERNATIONAL PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM 02/23/2005
K041343 DENTSPLY INTERNATIONAL XENO NM LIGHT CURED DENTAL ADHESIVE 06/16/2004
K151619 DENTSPLY INTERNATIONAL INC. Prime&Bond Elect Universal Dental Adhesive 10/30/2015
K891455 DENTSPLY INTL. DENTIN PRIMER 05/18/1989
K852660 DENTSPLY INTL. ETCH AND BOND 07/25/1985
K941572 DENTSPLY INTL. FLUORIDE-PSA PRIME/ADHESIVE 06/10/1994
K863522 DENTSPLY INTL. MODIFIED SELF-CURE BONDING AGENT 09/19/1986
K930504 DENTSPLY INTL. NEW DENTIN PRIMER 05/27/1993
K931812 DENTSPLY INTL. NEW DENTINE ADHESIVE 07/08/1993
K851056 DENTSPLY INTL. OPAQUER/BONDING AGENT 04/22/1985
K960823 DENTSPLY INTL. PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT 04/26/1996
K964525 DENTSPLY INTL. PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR 01/22/1997
K962348 DENTSPLY INTL. PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT 07/18/1996
K951864 DENTSPLY INTL. PRIME & BOND DIRECT COMPOSITE BONDING AGENT 05/23/1995
K982394 DENTSPLY INTL. PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM 09/21/1998
K915830 DENTSPLY INTL. PRISMA UNIVERSAL BOND(R) 3 03/02/1992
K801093 DENTSPLY INTL. PRISMA-BOND 05/20/1980
K874074 DENTSPLY INTL. TEMPORARY DISCLOSING SOLUTION 12/29/1987
K982007 DENTSPLY INTL. TRUBYTE DENTURE BOND DENTURE BONDING AGENT 07/22/1998
K051463 DENTSPLY INTL. XENO ADHESIVE WITH ACTIVATOR 07/12/2005
K023776 DENTSPLY INTL. XENO III DENTAL ADHESIVE 01/23/2003
K070538 DENTSPLY INTL. XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE 03/14/2007
K181476 Dentsply Sirona Prime&Bond active Universal Adhesive 09/28/2018
K150696 Dharma Research, Inc. Jade 37% Phosphoric Acid Etchant Gel 06/23/2015
K131248 DMG AMERICA, LLC ETCH GEL 07/11/2013
K992879 DMG HAMBURG ECUSIT COMPOSITE REPAIR 11/09/1999
K041960 DMG USA, INC. COMPOSITE/COMPOMER REPAIR KIT 08/30/2004
K063444 DMG USA, INC. TOTAL ETCH BONDING AGENT 03/20/2007
K102254 DMP LTD DMP SINGLE BONDING 11/23/2010
K152110 E DENTAL PRODUCTS e-1 etchants 11/20/2015
K953592 E&D DENTAL PRODUCTS, INC. REVOLUTION BOND 09/07/1995
K983414 ESPE DENTAL AG EVERBOND 12/16/1998
K992048 ESPE DENTAL AG MODIFICATION OF PROMPT L-POP 08/16/1999
K001494 ESPE DENTAL AG MODIFICATION TO PROMPT L-POP 07/07/2000
K984246 ESPE DENTAL AG PROMPT L-POP 01/08/1999
K962428 ESPE GMBH & CO. KG. EBS (ESPE BONDING SYSTEM) 09/12/1996
K913965 ESPE GMBH (US) ESPE(R) -SIL 12/04/1991
K884752 ESPE GMBH (US) KETAC-GLAZE 01/19/1989
K771326 ESPE GMBH (US) NIMETIC BONDING MATERIAL 08/02/1977
K771325 ESPE GMBH (US) NIMETIC ETCHING GEL 08/02/1977
K900558 ESPE GMBH (US) PERTAC BOND 04/10/1990
K904289 ESPE GMBH (US) PERTAC UNIVERSAL BOND 11/01/1990
K771328 ESPE GMBH (US) UVIOBOND 08/03/1977
K790833 ESPE GMBH (US) VISIO-BOND 04/30/1979
K812116 ESPE-PREMIER SALES CO. PERMAGUM 08/31/1981
K812117 ESPE-PREMIER SALES CO. PERMAGUM ADHESIVE 08/31/1981
K810265 ESPE-PREMIER SALES CO. VISIO-BAND 02/23/1981
K041471 GC AMERICA INC. G-BOND 06/29/2004
K180917 GC America Inc. GC Acrylic Primer 11/20/2018
K953166 GC AMERICA, INC. FUJI BOND LC 09/27/1995
K082768 GC AMERICA, INC. G-BOND PLUS 10/21/2008
K143140 GC AMERICA, INC. G-Premio BOND 04/20/2015
K981514 GC AMERICA, INC. GC FUJI BOND LC 06/16/1998
K935961 GC AMERICA, INC. GC FUJI COAT LC 03/10/1994
K972594 GC AMERICA, INC. METALPRIMER II 08/26/1997
K013997 GC AMERICA, INC. UNIFIL BOND 02/20/2002
K043170 HARRY J. BOSWORTH CO. BOSWORTH BOND 02/25/2005
K061611 HARRY J. BOSWORTH CO. BOSWORTH DENTIN RESIN 09/11/2006
K953405 HEALTH-DENT INTL., INC. HEMA-BENZ 09/27/1995
K951220 HEALTH-DENT INTL., INC. HEMA-GLU 05/12/1995
K051006 HERAEUS KULZER GMBH IBOND NEXT GENERATION 06/07/2005
K083652 HERAEUS KULZER GMBH IBOND TOTAL ETCH 01/21/2009
K150933 Heraeus Kulzer LLC, Mitsui Chemicals Group iBond Universal & iBond Ceramic Primer 07/07/2015
K971733 HERAEUS KULZER, INC. 2 BOND 2 10/02/1997
K935735 HERAEUS KULZER, INC. ATTACHMENT BOND 03/07/1994
K964038 HERAEUS KULZER, INC. CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG 04/02/1997
K931838 HERAEUS KULZER, INC. DENTHESIVE II 07/08/1993
K921701 HERAEUS KULZER, INC. DURAFILL BOND 06/09/1992
K992985 HERAEUS KULZER, INC. GLUMA COMFORT BOND 10/14/1999
K992292 HERAEUS KULZER, INC. GLUMA COMFORT BOND + DESENSITIZER 10/01/1999
K964140 HERAEUS KULZER, INC. GLUMA CONDITIONER 11/05/1996
K962812 HERAEUS KULZER, INC. GLUMA DESENSITIZER/GLUMA 3 PRIMER 10/07/1996
K974390 HERAEUS KULZER, INC. GLUMA ONE BOND 02/04/1998
K990143 HERAEUS KULZER, INC. GLUMA ONE BOND 02/25/1999
K063062 HERAEUS KULZER, INC. HKBOND 2006 12/01/2006
K022612 HERAEUS KULZER, INC. IBOND GLUMA INSIDE 10/28/2002
K896382 HERAEUS KULZER, INC. MODIFIED GLUMA BONDING SYSTEM 02/01/1990
K970848 HERAEUS KULZER, INC. SILOC SYSTEM 05/06/1997
K972101 HERAEUS KULZER, INC. SOLITAIRE 09/29/1997
K123278 HERAEUS KULZER, LLC IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF 12/07/2012
K122522 ITENA CLINICAL DEUTOETCH QUICKBOND BOND ACTIRATOR 03/19/2013
K990534 IVOCLAR NORTH AMERICA, INC. EXCITE 03/19/1999
K003293 IVOCLAR NORTH AMERICA, INC. EXCITE DSC 02/06/2001
K011490 IVOCLAR NORTH AMERICA, INC. MODIFICATION TO EXCITE 06/27/2001
K910069 IVOCLAR NORTH AMERICA, INC. SR-ISOSIT SPECTRA LINK SYSTEM 03/02/1992
K901913 IVOCLAR NORTH AMERICA, INC. SYNTAC (DENTIN BONDING AGENT) 06/26/1990
K133318 IVOCLAR VIVADENT AG ADHESE UNIVERSAL 02/11/2014
K150164 IVOCLAR VIVADENT AG Monobond Etch & Prime 04/03/2015
K070646 IVOCLAR VIVADENT, INC. ADHESE ONE 05/11/2007
K090941 IVOCLAR VIVADENT, INC. ADHESE ONE F 07/17/2009
K062713 IVOCLAR VIVADENT, INC. ADHESIVE DC ACTIVATOR 11/02/2006
K093744 IVOCLAR VIVADENT, INC. EXCITE F AND EXCITE DSC 03/10/2010
K013584 IVOCLAR VIVADENT, INC. EXCITE SELF ETCH 01/28/2002
K090826 IVOCLAR VIVADENT, INC. MONOBOND PLUS 05/11/2009
K060882 J. MORITA USA, INC. EXCEL BOND DC, MODEL 28-200100 09/01/2006
K061322 J. MORITA USA, INC. PORCELAIN PRIMER 06/02/2006
K894391 JELENKO CO. PVS DUAL CURE VENEER BONDING KIT 09/19/1989
K994359 JENERIC/PENTRON, INC. BOND 1 C & B 03/21/2000
K013543 JENERIC/PENTRON, INC. BOND-1 C & B 02/22/2002
K020499 JENERIC/PENTRON, INC. BOND-3 ADHESIVE 04/22/2002
K953859 JENERIC/PENTRON, INC. BOND-IT DUAL CURE ACTIVATOR 09/07/1995
K904724 JENERIC/PENTRON, INC. CONQUEST DIRECT FILLING COMPOSITE (DFC) 12/07/1990
K973388 JENERIC/PENTRON, INC. DENTIN CONDITIONING AND ADHESIVE (BOND 1) 09/12/1997
K936222 JENERIC/PENTRON, INC. DENTIN CONDITIONING AND ADHESIVE SYSTEM 03/15/1994
K013542 JENERIC/PENTRON, INC. DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1) 02/14/2002
K003011 JENERIC/PENTRON, INC. SELF ETCH BONDING PRIMER 11/28/2000
K822451 JOHNSON & JOHNSON PROFESSIONALS, INC. AURAFILL* DENTAL RESTORATIVE BONDING AG. 09/07/1982
K833473 JOHNSON & JOHNSON PROFESSIONALS, INC. DENTIN BONDING AGENT 12/27/1983
K833718 JOHNSON & JOHNSON PROFESSIONALS, INC. ETCHING GEL 12/29/1983
K842078 JOHNSON & JOHNSON PROFESSIONALS, INC. JOHNSON & JOHNSON FLAVORED ETCHING GEL 07/12/1984
K830387 JOHNSON & JOHNSON PROFESSIONALS, INC. MICRODAPT DENTAL RESTORATIVE BONDING 03/17/1983
K182162 Kerr Corporation OptiBond eXTRa Universal 11/07/2018
K100347 KERR CORPORATION OPTIBOND SE 04/30/2010
K101423 KERR CORPORATION OPTIBOND XTR 07/30/2010
K880684 KERR CORPORATION (DANBURY) "XR PRIMER" 05/11/1988
K843025 KERR CORPORATION (DANBURY) COMMAND ENAMEL-DENT DENTAL ADHESIVE 10/25/1984
K934690 KERR CORPORATION (DANBURY) KERR OPTIBOND, MODIFICATION 12/30/1993
K843023 KERR CORPORATION (DANBURY) KERR PORCELAIN REPAIR PRIMER 10/25/1984
K860346 KERR CORPORATION (DANBURY) KERR PORCELITE 03/25/1986
K940513 KERR CORPORATION (DANBURY) OPTIBOND 04/15/1994
K923546 KERR CORPORATION (DANBURY) OPTIBOND 09/29/1992
K962515 KERR DENTAL MATERIALS CENTER KERR ADVANCED ADHESIVE 08/01/1996
K031444 KERR DENTAL MATERIALS CENTER OPTIBOND FL 07/02/2003
K014027 KERR DENTAL MATERIALS CENTER OPTIBOND SOLO PLUS 4 02/22/2002
K020303 KERR DENTAL MATERIALS CENTER XR PRIMER 2 04/19/2002
K905302 KULZER, INC. DENTHESIVE 02/26/1991
K974089 KURARAY AMERICA, INC. ALLOY PRIMER 12/17/1997
K974486 KURARAY AMERICA, INC. CLEARFIL LINER BOND 2V 01/29/1998
K111980 KURARAY AMERICA, INC. CLEARFIL TRI-S BOND PLUS 10/14/2011
K912707 KURARAY CO. CLEARFIL LINER BOND SYSTEM 08/20/1991
K872959 KURARAY CO. CLEARFIL PHOTO BOND 11/20/1987
K871636 KURARAY CO. CLEARFIL PORCELAIN BOND 07/02/1987
K925404 KURARAY CO. CLEARFIL PORCELAIN BOND ACTIVATOR 01/11/1993
K990040 KURARAY CO. CLEARFIL SE BOND 02/04/1999
K943170 KURARAY COMPANY, LTD. CLEARFIL LINER BOND 2 08/10/1994
K943166 KURARAY COMPANY, LTD. CLEARFIL LINER BOND SYSTEM 08/10/1994
K943167 KURARAY COMPANY, LTD. CLEARFIL NEW BOND 08/10/1994
K943165 KURARAY COMPANY, LTD. CLEARFIL PHOTO BOND 08/10/1994
K001914 KURARAY COMPANY, LTD. CLEARFIL REPAIR 08/10/2000
K936100 KURARAY INTL. CORP. CLEARFIL LINER BOND 2 02/03/1994
K062382 KURARAY MEDICAL INC. CLEARFIL DC BOND 09/27/2006
K012734 KURARAY MEDICAL INC. CLEARFIL NEW BOND 09/14/2001
K012730 KURARAY MEDICAL INC. CLEARFIL PORCELAIN BOND ACTIVATOR 09/13/2001
K033938 KURARAY MEDICAL INC. CLEARFIL PROTECT BOND 01/29/2004
K012729 KURARAY MEDICAL INC. CLEARFIL REPAIR 09/13/2001
K021427 KURARAY MEDICAL INC. CLEARFIL SA PRIMER 06/07/2002
K023842 KURARAY MEDICAL INC. CLEARFIL SE BOND PLUS 02/11/2003
K024356 KURARAY MEDICAL INC. CLEARFIL SILANE KIT 03/26/2003
K042913 KURARAY MEDICAL INC. CLEARFIL TRI-S BOND 11/26/2004
K111975 KURARAY MEDICAL INC. CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK 10/14/2011
K012436 KURARAY MEDICAL INC. MODIFICATION TO ALLOY PRIMER 09/04/2001
K012440 KURARAY MEDICAL INC. MODIFICATION TO CLEARFIL LINER BOND 2V 09/05/2001
K012432 KURARAY MEDICAL INC. MODIFICATION TO CLEARFIL PHOTO BOND 09/04/2001
K012442 KURARAY MEDICAL INC. MODIFICATION TO CLEARFIL SE BOND 09/10/2001
K051796 KURARAY MEDICAL KURASHIKI PLANT CLEARFIL TRI-S BOND SINGLE DOSE 08/09/2005
K150703 KURARAY NORITAKE DENTAL INC. CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) 08/13/2015
K131430 KURARAY NORITAKE DENTAL INC. CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL 08/30/2013
K131432 KURARAY NORITAKE DENTAL INC. CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL 08/22/2013
K132450 KURARAY NORITAKE DENTAL INC. CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND 11/01/2013
K133078 KURARAY NORITAKE DENTAL INC. K-ETCHANT SYRINGE; NEEDLE TIP (E) 12/20/2013
K161042 Kuraray Noritake Dental, Inc. CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack 10/25/2016
K760400 L.D. CAULK CO. BONDING AGENT, VYTOL 08/23/1976
K760324 LEE PHARMACEUTICALS BONDING AGENT, PRESTIGE 08/03/1976
K912256 LEE PHARMACEUTICALS PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERT 07/24/1991
K894315 LEE PHARMACEUTICALS RESTOBOND 3/DENTIN-ENAMEL BONDING AGENT 10/31/1989
K924378 LEE PHARMACEUTICALS RESTOBOND 4 03/31/1993
K840726 LEE PHARMACEUTICALS RESTODENT DENTIN BONDING AGENT 06/27/1984
K180802 META BIOMED, CO., LTD. Meta P&Bond 08/29/2018
K955740 MIDWEST ORTHODONTIC MFG. GLUFLORMA 02/08/1996
K933360 MILES INC., DENTAL PRODUCTS GLUMA 3 STEP BONDING SYSTEM/ GLUMA 3 PRIMER/DESENSITIZER 11/22/1994
K993013 MIRADENT DISTRIBUTING CO., LLC. SURE BOND 11/29/1999
K915511 MIRAGE DENTAL SYSTEMS MIRAGE COMPLETE KIT AND MIRAGE ABC KIT 03/06/1992
K112597 MYCONE DENTAL SUPPLY CO., INC. SEITY 37% PHOSPHORIC ACID ETCHANT GEL 12/07/2011
K172977 Nanova Biomaterials Inc Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel 01/16/2018
K862829 PANADENT INTERNATIONAL, INC. "PANAGRAF" 09/19/1986
K892003 PARKELL ABRAKADABRA - DENTAL ADHESIVE SYSTEM 06/07/1989
K895750 PARKELL HEMA-PRIMER 12/21/1989
K884918 PARKELL PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER 02/13/1989
K952124 PARKELL, INC. ABOND 06/20/1995
K960879 PARKELL, INC. AMALGAMIBOND PLUS 03/22/1996
K151518 Parkell, Inc. BRUSH&BOND PLUS 09/18/2015
K950905 PARKELL, INC. C&B-METABOND RADIOPAQUE POWDER 04/10/1995
K032179 PARKELL, INC. COMP. E 09/09/2003
K972421 PARKELL, INC. EASY BOND 08/29/1997
K142848 Parkell, Inc. EAZY PRIMER 02/24/2015
K964867 PARKELL, INC. HYBRID RESIN COMPOSITE 04/11/1997
K952123 PARKELL, INC. MS EMULSION 06/20/1995
K172176 Parkell, Inc. Parkell Universal Adhesive 11/21/2017
K994302 PARKELL, INC. RESIN TOOTH BONDING AGENT 02/07/2000
K020239 PARKELL, INC. TOUCH&BOND-PLUS 03/20/2002
K942017 PARKELL, INC. V-PRIMER 07/06/1994
K111431 PENTRON CLINICAL B1P ADHESIVE 08/01/2011
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