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 |
| K011167 | 3M COMPANY | XSE | 05/17/2001 |
| K192961 | 3M Deutschland GmbH | ADH19 | 10/31/2019 |
| 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 |
| 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 |
| K200462 | Belport Company, Inc., Gingi-Pak | EtchPro Etching Gel | 09/02/2020 |
| 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 |
| 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 |
| 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 |
| K964000 | BISCO, INC. | BISFIL 2B | 11/05/1996 |
| K112118 | BISCO, INC. | DREAMBOND | 11/17/2011 |
| K091705 | BISCO, INC. | PRIMER PLUS | 08/28/2009 |
| K013519 | BISCO, INC. | SIMPLE | 01/17/2002 |
| K961822 | BISCO, INC. | WET-PREP | 06/11/1996 |
| 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 |
| K983545 | CAVEX HOLLAND B.V. | QUADRANT UNIBOND | 11/18/1998 |
| K042806 | CAVEX HOLLAND B.V. | QUADRANT UNIT-1-BOND | 11/24/2004 |
| 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 |
| K973002 | CHENG & ASSOC., INC. | HURRISEAL DENTIN DESENSITIZER | 03/23/1998 |
| K152243 | Coltene/Whaledent AG | One Coat 7 Universal | 12/09/2015 |
| 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 |
| K052501 | COSMEDENT, INC. | MULTIPLE RESIN TOOTH BONDING AGENT | 10/21/2005 |
| 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 |
| K041680 | DEL PHARMACEUTICALS, INC. | ORAJEL ADVANCED TOOTH DESENSITIZER | 11/10/2004 |
| K140537 | DEN-MAT HOLDINGS, LLC | TENURE4G | 08/20/2014 |
| K222357 | DenMat Holding, LLC | DenMat Glutaraldehyde Desensitizer | 08/09/2022 |
| K962277 | DENT ZAR, INC. | SELF CURE BONDING AGENT | 07/03/1996 |
| K183424 | DentsCare LTDA | Ambar, Ambar APS, Ambar Universal APS | 12/13/2019 |
| 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 |
| K051707 | DENTSPLY INTL. | ECLIPSE BONDING AGENT | 07/15/2005 |
| 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 |
| K982394 | DENTSPLY INTL. | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM | 09/21/1998 |
| 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 |
| K220804 | Diadent Group International | Dia-X Bond Universal | 06/15/2022 |
| K192273 | Diadent Group International | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | 02/07/2020 |
| K192392 | Diadent Group International | DiaPlus | 05/26/2020 |
| K213401 | Diadent Group International | DIAPLUS Universal | 01/31/2022 |
| 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 |
| 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 |
| K200682 | GC America Inc. | BZF-29 | 10/02/2020 |
| K041471 | GC AMERICA INC. | G-BOND | 06/29/2004 |
| K180917 | GC America Inc. | GC Acrylic Primer | 11/20/2018 |
| 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 |
| K972594 | GC AMERICA, INC. | METALPRIMER II | 08/26/1997 |
| K013997 | GC AMERICA, INC. | UNIFIL BOND | 02/20/2002 |
| K200153 | GENOSS Co., Ltd. | Bright Bond Universal | 10/28/2020 |
| K043170 | HARRY J. BOSWORTH CO. | BOSWORTH BOND | 02/25/2005 |
| K061611 | HARRY J. BOSWORTH CO. | BOSWORTH DENTIN RESIN | 09/11/2006 |
| 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 |
| K964038 | HERAEUS KULZER, INC. | CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG | 04/02/1997 |
| 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 |
| 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 |
| K192913 | Imicryl Dis Malzemeleri Sanayi Ve Ticaret A.S. | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | 01/19/2021 |
| K122522 | ITENA CLINICAL | DENTOETCH QUICKBOND BOND ACTIVATOR | 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 |
| K133318 | IVOCLAR VIVADENT AG | ADHESE UNIVERSAL | 02/11/2014 |
| K150164 | IVOCLAR VIVADENT AG | Monobond Etch & Prime | 04/03/2015 |
| K210804 | Ivoclar Vivadent, AG | Adhese Universal DC, Cention Primer | 06/07/2022 |
| 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 |
| 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 |
| K973388 | JENERIC/PENTRON, INC. | DENTIN CONDITIONING AND ADHESIVE (BOND 1) | 09/12/1997 |
| 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 |
| 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 |
| K222830 | Kerr Corporation | Rainbow 360 | 01/12/2023 |
| 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 |
| K191523 | Kettenbach GmbH & Co. KG | Visalys Restorative Primer | 10/09/2019 |
| K191524 | Kettenbach GmbH & Co. KG | Visalys Tooth Primer | 09/29/2019 |
| 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 |
| K990040 | KURARAY CO. | CLEARFIL SE BOND | 02/04/1999 |
| K001914 | KURARAY COMPANY, LTD. | CLEARFIL REPAIR | 08/10/2000 |
| 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 |
| K230465 | Mediclus Co., LTD. | Hi-Bond Universal | 05/22/2023 |
| K230009 | Meta Biomed Co., LTD. | EZ Bond Universal | 03/03/2023 |
| K180802 | META BIOMED, CO., LTD. | Meta P&Bond | 08/29/2018 |
| K955740 | MIDWEST ORTHODONTIC MFG. | GLUFLORMA | 02/08/1996 |
| K993013 | MIRADENT DISTRIBUTING CO., LLC. | SURE BOND | 11/29/1999 |
| 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 |
| K183391 | Nobio Ltd. | Novidia Universal Bond | 09/24/2019 |
| K210186 | Pac-Dent, Inc. | PacBond One | 07/16/2021 |
| K960879 | PARKELL, INC. | AMALGAMIBOND PLUS | 03/22/1996 |
| K151518 | Parkell, Inc. | BRUSH&BOND PLUS | 09/18/2015 |
| 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 |
| 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 |
| K111431 | PENTRON CLINICAL | B1P ADHESIVE | 08/01/2011 |
| K072480 | PENTRON CLINICAL TECHNOLOGIES | GENERATION 8 SE ADHESIVE | 11/21/2007 |
| K071500 | PENTRON CLINICAL TECHNOLOGIES | NANO-BOND II ADHESIVE SYSTEM | 08/10/2007 |
| K131212 | PREMIER DENTAL PRODUCTS CO. | PREMIER CERAMIC PRIMER | 08/26/2013 |
| K141839 | PREMIER DENTAL PRODUCTS CO. | PREMIER ETCH | 11/17/2014 |
| K061998 | PREMIER DENTAL PRODUCTS CO. | PREMIER SELF-ETCHING BOND ENHANCER | 10/04/2006 |
| K231696 | Prevest Denpro Limited | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | 08/11/2023 |
| K993683 | PULPDENT CORP. | PULPDENT UNO-DUO | 12/13/1999 |
| K032953 | PULPDENT CORPORATION | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT | 12/10/2003 |
| K120213 | PULPDENT CORPORATION | ETCH-RITE SUPREME | 03/30/2012 |
| K031915 | PULPDENT CORPORATION | PULPDENT ETCH-RITE ROYALE | 08/05/2003 |
| K020514 | PULPDENT CORPORATION | PULPDENT GLAZE II | 05/16/2002 |
| K210945 | Reliance Orthodontic Products, Inc | Ultra SEP | 07/08/2021 |
| K071688 | RELIANCE ORTHODONTIC PRODUCTS, INC. | RELIANCE S.E.P. | 09/07/2007 |
| K020050 | RITE-DENT MANUFACTURING CORP. | ENAMEL BONDING SYSTEM | 02/14/2002 |
| K201787 | Rizhao HuGe Biomaterials Company, Ltd. | Light Cure Dental Adhesive | 09/25/2020 |
| K221450 | Rizhao HuGe Biomaterials Company, Ltd. | Phosphoric Acid Etching Gel | 09/12/2022 |
| K213093 | Rounding Third LLC | STEP-1 PumEtch | 01/28/2022 |
| K002502 | S & C POLYMER GMBH | CERAM-PRIME | 11/08/2000 |
| K042614 | S & C POLYMER GMBH | S&C-SELF ETCH PR-BOND | 11/22/2004 |
| K221033 | S&C Polymer Silicon- und Composite SpezialitΣten GmbH | UniPrime A, UniPrime E, UniPrime E/C | 07/06/2022 |
| K052189 | SCHUTZ-DENTAL GMBH | REVENEER CERAMIC REPAIR SYSTEM | 10/17/2005 |
| K051050 | SCHUTZ-DENTAL GMBH | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | 06/29/2005 |
| K191656 | SDI Limited | Zipbond | 12/02/2019 |
| K082744 | SHOFU DENTAL CORP. | BEAUTIBOND | 12/11/2008 |
| K110235 | SHOFU DENTAL CORP. | BEAUTIBOND MULTI | 05/13/2011 |
| K110252 | SHOFU DENTAL CORP. | BEAUTIBOND MULTI PR PLUS | 05/13/2011 |
| K071452 | SHOFU DENTAL CORP. | FL BOND II | 07/09/2007 |
| K040079 | SHOFU DENTAL CORP. | M.L. PRIMER | 09/09/2004 |
| K180803 | Shofu Dental Corporation | BeautiBond Universal | 09/26/2018 |
| K213965 | Shofu Dental Corporation | BeautiBond Xtreme | 03/18/2022 |
| K123119 | SHOFU DENTAL CORPORATION | CERARESIN BOND | 11/28/2012 |
| K161891 | Shofu Dental Corporation | HC Primer | 11/21/2016 |
| K172106 | Shofu Dental Corporation | SHOFU MZ Primer Plus | 08/31/2017 |
| K110403 | SILMET LTD. | PROLINK ADHESIVES (PROLINK, PROLINK SE) | 09/08/2011 |
| K232978 | Sino-Dentex Co., Ltd. | DX. Bond V Dental Bonding Adhesive | 09/22/2023 |
| K050331 | SOUTHERN DENTAL INDUSTRIES, INC. | ADHESIVE 1 | 03/24/2005 |
| K981383 | SOUTHERN DENTAL INDUSTRIES, INC. | ALLOYBOND | 06/16/1998 |
| K973092 | SOUTHERN DENTAL INDUSTRIES, INC. | STAE | 12/08/1997 |
| K010415 | SPECIALITES SEPTODONT | ISODAN | 07/23/2001 |
| K120767 | SPIDENT CO., LTD. | ES BOND | 05/24/2012 |
| K052699 | SULTAN CHEMISTS, INC. | VERSA-LINK PORCELAIN BONDING SYSTEM | 11/16/2005 |
| K000954 | SYBRON DENTAL SPECIALTIES, INC. | KERR GEL ETCHANT | 04/28/2000 |
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| K990498 | SYBRON DENTAL SPECIALTIES, INC. | OPTIBOND SOLO PLUS | 03/08/1999 |
| K991808 | SYBRON DENTAL SPECIALTIES, INC. | OPTIBOND SOLO PLUS 2 | 07/09/1999 |
| K012082 | SYBRON DENTAL SPECIALTIES, INC. | OPTIBOND SOLO PLUS ACTIVATOR | 09/20/2001 |
| K973245 | TOKUYAMA AMERICA, INC. | TOKUSO REBASE MR. BOND | 10/07/1997 |
| K993917 | TOKUYAMA AMERICA, INC. | TOKUYAMA ONE-UP-BOND F | 02/02/2000 |
| K070215 | TOKUYAMA DENTAL CORPORATION | TOKUYAMA BOND FORCE | 03/30/2007 |
| K171226 | Tokuyama Dental Corporation | TOKUYAMA UNIVERSAL BOND | 11/28/2017 |
| K203760 | Tokuyama Dental Corporation | Tokuyama Universal Bond II | 05/25/2021 |
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| K063557 | ULTRADENT PRODUCTS, INC. | PEAK BOND, MODEL 5133 | 12/12/2006 |
| K063558 | ULTRADENT PRODUCTS, INC. | PEAK SE, MODEL 5135 | 12/14/2006 |
| K100752 | ULTRADENT PRODUCTS, INC. | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | 07/16/2010 |
| K131357 | ULTRADENT PRODUCTS, INC. | PEAK Z | 09/06/2013 |
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| K032626 | ULTRADENT PRODUCTS, INC. | PERMAQUICK SE BONDING SYSTEM | 12/03/2003 |
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| K000189 | ULTRADENT PRODUCTS, INC. | PQ1 | 05/11/2000 |
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| K043562 | VERICOM CO., LTD. | BC PLUS | 01/03/2005 |
| K030844 | VOCO GMBH | FINAL VARNISH LC | 06/13/2003 |
| K130486 | VOCO GMBH | FUTURABOND UNIVERSAL | 06/20/2013 |
| K070723 | VOCO GMBH | FUTURABOND DC/SINGLE DOSE | 06/07/2007 |
| K082753 | VOCO GMBH | FUTURABOND M/FUTURABOND M SINGLE DOSE | 11/24/2008 |
| K141610 | VOCO GMBH | FUTURABOND M+ | 08/01/2014 |
| K042670 | VOCO GMBH | FUTURABOND NR | 11/01/2004 |
| K053392 | VOCO GMBH | FUTURABOND NR SINGLE DOSE | 12/15/2005 |
| K980539 | VOCO GMBH | SOLOBOND M | 03/23/1998 |
| K003153 | VOCO GMBH | SOLOBOND PLUS | 11/15/2000 |
| K984503 | WALLACE A. ERICKSON & CO. | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | 02/26/1999 |
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