Agent, Tooth Bonding, Resin
FDA product code KLE · Class II (moderate risk) · 21 CFR 872.3200 · Dental
419510(k) clearances
0PMA approvals
11recalls
Manufacturers
- Dentsply Intl. 20
- Heraeus Kulzer, Inc. 19
- Ultradent Products, Inc. 19
- Bisco, Inc. 18
- Parkell, Inc. 16
- Kuraray Medical, Inc. 14
- Shofu Dental Corp. 13
- Pulpdent Corp. 11
- GC America, Inc. 11
- Ivoclar Vivadent, Inc. 10
- Kuraray Co. 10
- Voco GmbH 10
- Jeneric/Pentron, Inc. 9
- Sybron Dental Specialties, Inc. 9
- Apex Dental Materials, Inc. 8
- Espe GmbH (Us) 8
- Kerr Corporation (Danbury) 7
- 3M Espe AG Dental Products 7
- Kuraray Noritake Dental, Inc. 7
- 3M Company 5
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml…KLE · Traditional | Spident Co., Ltd. | 11/01/2024SE |
| K240153 | Ceramic Etchant (HF-5 and HF-9)KLE · Traditional | Liaoning Upcera Co., Ltd. | 10/02/2024SE |
| K241445 | K-Bond UniversalKLE · Traditional | Spident Co., Ltd. | 07/22/2024SE |
| K241056 | Light Cure AdhesiveKLE · Traditional | Sincera Technology (Changchun) Co., Ltd. | 07/16/2024SE |
| K240743 | Peak Universal BondKLE · Special | Ultradent Products, Inc. | 03/20/2024SE |
| K231039 | CLEARFIL Universal Bond Quick 2KLE · Traditional | Kuraray Noritake Dental, Inc. | 12/13/2023SE |
| K232978 | DX. Bond V Dental Bonding AdhesiveKLE · Traditional | Sino-Dentex Co., Ltd. | 09/22/2023SE |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalKLE · Traditional | Prevest Denpro Limited | 08/11/2023SE |
| K230465 | Hi-Bond UniversalKLE · Traditional | Mediclus Co., Ltd. | 05/22/2023SE |
| K230009 | EZ Bond UniversalKLE · Traditional | Meta Biomed Co., Ltd. | 03/03/2023SE |
| K222830 | Rainbow 360KLE · Traditional | Kerr Corporation | 01/12/2023SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 09/12/2022SE |
| K222357 | DenMat Glutaraldehyde DesensitizerKLE · Traditional | Denmat Holding, LLC | 08/09/2022SE |
| K221033 | UniPrime A, UniPrime E, UniPrime E/CKLE · Traditional | S&C Polymer Silicon- Und Composite Spezialitäten… | 07/06/2022SE |
| K220804 | Dia-X Bond UniversalKLE · Special | DiaDent Group International | 06/15/2022SE |
| K210804 | Adhese Universal DC, Cention PrimerKLE · Traditional | Ivoclar Vivadent, AG | 06/07/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | Shofu Dental Corporation | 03/18/2022SE |
| K213401 | DIAPLUS UniversalKLE · Traditional | DiaDent Group International | 01/31/2022SE |
| K213093 | STEP-1 PumEtchKLE · Traditional | Rounding Third, LLC | 01/28/2022SE |
| K210186 | PacBond OneKLE · Traditional | Pac-Dent, Inc. | 07/16/2021SE |
| K210945 | Ultra SEPKLE · Traditional | Reliance Orthodontic Products, Inc. | 07/08/2021SE |
| K203760 | Tokuyama Universal Bond IIKLE · Traditional | Tokuyama Dental Corporation | 05/25/2021SE |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single DoseKLE · Traditional | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 01/19/2021SE |
| K200153 | Bright Bond UniversalKLE · Traditional | Genoss Co., Ltd. | 10/28/2020SE |
| K200682 | BZF-29KLE · Traditional | GC America, Inc. | 10/02/2020SE |
| K201787 | Light Cure Dental AdhesiveKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 09/25/2020SE |
| K200462 | EtchPro Etching GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 09/02/2020SE |
| K192392 | DiaPlusKLE · Traditional | DiaDent Group International | 05/26/2020SE |
| K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A…KLE · Traditional | DiaDent Group International | 02/07/2020SE |
| K183424 | Ambar, Ambar APS, Ambar Universal APSKLE · Traditional | Dentscare Ltda | 12/13/2019SE |
| K191656 | ZipbondKLE · Traditional | Sdi Limited | 12/02/2019SE |
| K192961 | ADH19KLE · Traditional | 3M Deutschland GmbH | 10/31/2019SE |
| K191523 | Visalys Restorative PrimerKLE · Traditional | Kettenbach GmbH & Co. KG | 10/09/2019SE |
| K191524 | Visalys Tooth PrimerKLE · Traditional | Kettenbach GmbH & Co. KG | 09/29/2019SE |
| K183391 | Novidia Universal BondKLE · Traditional | Nobio , Ltd. | 09/24/2019SE |
| K180917 | GC Acrylic PrimerKLE · Traditional | GC America, Inc. | 11/20/2018SE |
| K182162 | OptiBond eXTRa UniversalKLE · Traditional | Kerr Corporation | 11/07/2018SE |
| K181910 | BracePaste MTP Light Cure PrimerKLE · Traditional | American Orthodontics | 10/15/2018SE |
| K181476 | Prime&Bond active Universal AdhesiveKLE · Traditional | Dentsply Sirona | 09/28/2018SE |
| K180803 | BeautiBond UniversalKLE · Traditional | Shofu Dental Corporation | 09/26/2018SE |
| K180802 | Meta P&BondKLE · Traditional | Meta Biomed Co., Ltd. | 08/29/2018SE |
| K172953 | Acid EtchantKLE · Traditional | American Orthodontics | 02/06/2018SE |
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant GelKLE · Traditional | Nanova Biomaterials, Inc. | 01/16/2018SE |
| K171226 | Tokuyama Universal BondKLE · Traditional | Tokuyama Dental Corporation | 11/28/2017SE |
| K172176 | Parkell Universal AdhesiveKLE · Traditional | Parkell, Inc. | 11/21/2017SE |
| K172106 | SHOFU MZ Primer PlusKLE · Traditional | Shofu Dental Corporation | 08/31/2017SE |
| K161077 | RnD TE and RnD SEKLE · Traditional | Apex Dental Materials, Inc. | 03/17/2017SE |
| K161891 | HC PrimerKLE · Traditional | Shofu Dental Corporation | 11/21/2016SE |
| K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle…KLE · Traditional | Kuraray Noritake Dental, Inc. | 10/25/2016SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | Bisco, Inc. | 09/09/2016SE |
| K152243 | One Coat 7 UniversalKLE · Traditional | Coltene/Whaledent AG | 12/09/2015SE |
| K152110 | e-1 etchantsKLE · Traditional | E Dental Products | 11/20/2015SE |
| K151619 | Prime&Bond Elect Universal Dental AdhesiveKLE · Traditional | Dentsply International, Inc. | 10/30/2015SE |
| K151518 | Brush&Bond PlusKLE · Traditional | Parkell, Inc. | 09/18/2015SE |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial)KLE · Traditional | Kuraray Noritake Dental, Inc. | 08/13/2015SE |
| K150933 | iBond Universal & iBond Ceramic PrimerKLE · Traditional | Heraeus Kulzer, LLC, Mitsui Chemicals Group | 07/07/2015SE |
| K150696 | Jade 37% Phosphoric Acid Etchant GelKLE · Traditional | Dharma Research, Inc. | 06/23/2015SE |
| K143140 | G-Premio BONDKLE · Traditional | GC America, Inc. | 04/20/2015SE |
| K150164 | Monobond Etch & PrimeKLE · Traditional | Ivoclar Vivadent, AG | 04/03/2015SE |
| K142848 | Eazy PrimerKLE · Traditional | Parkell, Inc. | 02/24/2015SE |
| K141839 | Premier EtchKLE · Traditional | Premier Dental Products Co. | 11/17/2014SE |
| K140537 | TENURE4GKLE · Traditional | Den-Mat Holdings, LLC | 08/20/2014SE |
| K141610 | Futurabond M+KLE · Special | Voco GmbH | 08/01/2014SE |
| K131734 | All-Bond Universal SC (Not Finalized)KLE · Traditional | Bisco, Inc. | 04/11/2014SE |
| K133318 | Adhese UniversalKLE · Traditional | Ivoclar Vivadent, AG | 02/11/2014SE |
| K132923 | Fusion Single LinkKLE · Traditional | Angelus Industria DE Productos Odontologicos SA | 01/03/2014SE |
| K133078 | K-Etchant Syringe; Needle Tip (E)KLE · Traditional | Kuraray Noritake Dental, Inc. | 12/20/2013SE |
| K132450 | Clearfil Universal Bond Value Pack, Clearfil Universaly Bond Trial, Clearfil Universal…KLE · Traditional | Kuraray Noritake Dental, Inc. | 11/01/2013SE |
| K131043 | Apex Universal AdhesiveKLE · Traditional | Apex Dental Materials, Inc. | 09/10/2013SE |
| K131357 | Peak ZKLE · Traditional | Ultradent Products, Inc. | 09/06/2013SE |
| K131430 | Clearfil DC Activator; Clearfil DC Activator TrialKLE · Traditional | Kuraray Noritake Dental, Inc. | 08/30/2013SE |
| K131049 | ZRPKLE · Traditional | Apex Dental Materials, Inc. | 08/27/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | Premier Dental Products Co. | 08/26/2013SE |
| K131432 | Clearfil Se Bond 2 Kit; Clearfil Se Bond 2 Value Pack; Clearfil Se Bond 2 Trial Pack…KLE · Traditional | Kuraray Noritake Dental, Inc. | 08/22/2013SE |
| K131248 | Etch GelKLE · Traditional | Dmg America, LLC | 07/11/2013SE |
| K130486 | Futurabond UniversalKLE · Traditional | Voco GmbH | 06/20/2013SE |
| K122522 | Dentoetch Quickbond Bond ActivatorKLE · Traditional | Itena Clinical | 03/19/2013SE |
| K123278 | Ibond Self Etch Bottle Assortment, Ibond Self Etch Bottle Value Pack, Ibond Self Etch…KLE · Special | Heraeus Kulzer, LLC | 12/07/2012SE |
| K123119 | Ceraresin BondKLE · Traditional | Shofu Dental Corporation | 11/28/2012SE |
| K120620 | Clean and BoostKLE · Traditional | Apex Dental Materials, Inc. | 05/31/2012SE |
| K120767 | Es BondKLE · Traditional | Spident Co., Ltd. | 05/24/2012SE |
| K120213 | Etch-Rite SupremeKLE · Traditional | Pulpdent Corporation | 03/30/2012SE |
| K112597 | Seity 37% Phosphoric Acid Etchant GelKLE · Traditional | Mycone Dental Supply Co., Inc. | 12/07/2011SE |
| K112118 | DreambondKLE · Traditional | Bisco, Inc. | 11/17/2011SE |
| K111980 | Clearfil Tri-S Bond PlusKLE · Traditional | Kuraray America, Inc. | 10/14/2011SE |
| K111975 | Clearfil Tri-S Bond Plus Single Dose Standard / Value / Introductory PackKLE · Traditional | Kuraray Medical, Inc. | 10/14/2011SE |
| K111876 | Z Bond, Prelude OneKLE · Traditional | Danville Materials, Inc. | 09/21/2011SE |
| K110403 | Prolink Adhesives (Prolink, Prolink Se)KLE · Traditional | Silmet , Ltd. | 09/08/2011SE |
| K111431 | B1P AdhesiveKLE · Traditional | Pentron Clinical | 08/01/2011SE |
| K110302 | Adhesive EXL-759KLE · Traditional | 3M Espe AG | 05/19/2011SE |
| K110252 | Beautibond Multi PR PlusKLE · Traditional | Shofu Dental Corp. | 05/13/2011SE |
| K110235 | Beautibond MultiKLE · Traditional | Shofu Dental Corp. | 05/13/2011SE |
| K102254 | DMP Single BondingKLE · Traditional | Dmp, Ltd. | 11/23/2010SE |
| K102844 | All-Bound 3KLE · Special | Bisco, Inc. | 10/29/2010SE |
| K101485 | All-Etch, All- Etch with Bac; Uni- Etch, Uni- Etch with Bac; Etch- 37, Etch- 37 with…KLE · Traditional | Bisco, Inc. | 08/26/2010SE |
| K101423 | Optibond XTRKLE · Traditional | Kerr Corporation | 07/30/2010SE |
| K100752 | Peak Universal Bond (Light Cure Resin Adhesive and Chlorhexidine)KLE · Traditional | Ultradent Products, Inc. | 07/16/2010SE |
| K100347 | Optibond SeKLE · Traditional | Kerr Corporation | 04/30/2010SE |
| K093014 | American Dental Products Se BondeasyKLE · Traditional | American Dental Products, Inc. | 04/16/2010SE |
| K093744 | Excite F and Excite DSCKLE · Traditional | Ivoclar Vivadent, Inc. | 03/10/2010SE |
| K092616 | Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045KLE · Traditional | CAO Group, Inc. | 10/21/2009SE |
| K091705 | Primer PlusKLE · Traditional | Bisco, Inc. | 08/28/2009SE |
| K091300 | Ascent Porcelain Primer, Model 006-00078, 00600079KLE · Traditional | CAO Group, Inc. | 07/23/2009SE |
| K090941 | Adhese One FKLE · Traditional | Ivoclar Vivadent, Inc. | 07/17/2009SE |
| K090826 | Monobond PlusKLE · Traditional | Ivoclar Vivadent, Inc. | 05/11/2009SE |
| K090106 | Prelude OneKLE · Traditional | Danville Materials, Inc. | 03/31/2009SE |
| K083652 | Ibond Total EtchKLE · Traditional | Heraeus Kulzer,GmbH | 01/21/2009SE |
| K082744 | BeautibondKLE · Traditional | Shofu Dental Corp. | 12/11/2008SE |
| K082753 | Futurabond M/Futurabond M Single DoseKLE · Traditional | Voco GmbH | 11/24/2008SE |
| K082768 | G-Bond PlusKLE · Traditional | GC America, Inc. | 10/21/2008SE |
| K072480 | Generation 8 Se AdhesiveKLE · Traditional | Pentron Clinical Technologies | 11/21/2007SE |
| K071688 | Reliance S.E.P.KLE · Traditional | Reliance Orthodontic Products, Inc. | 09/07/2007SE |
| K071500 | Nano-Bond II Adhesive SystemKLE · Traditional | Pentron Clinical Technologies | 08/10/2007SE |
| K071131 | UnoKLE · Traditional | 3M Espe AG Dental Products | 07/25/2007SE |
| K071260 | Hermes Bond 3KLE · Traditional | 3M Espe AG Dental Products | 07/17/2007SE |
| K071452 | FL Bond IIKLE · Traditional | Shofu Dental Corp. | 07/09/2007SE |
| K070723 | Futurabond Dc/Single DoseKLE · Traditional | Voco GmbH | 06/07/2007SE |
| K070956 | SEA2 Self Etch AdhesiveKLE · Traditional | 3M Espe Dental Products | 05/22/2007SE |
| K070646 | Adhese OneKLE · Traditional | Ivoclar Vivadent, Inc. | 05/11/2007SE |
| K070413 | Ascent Universal Adhesive, Model 006-00028KLE · Traditional | CAO Group, Inc. | 04/26/2007SE |
| K070215 | Tokuyama Bond ForceKLE · Traditional | Tokuyama Dental Corporation | 03/30/2007SE |
| K063444 | Total Etch Bonding AgentKLE · Abbreviated | Dmg USA, Inc. | 03/20/2007SE |
| K070538 | XP Bond Dual Cure Universal Total Etch AdhesiveKLE · Special | Dentsply Intl. | 03/14/2007SE |
| K063780 | Ace Bond SeKLE · Special | Bisco, Inc. | 01/19/2007SE |
| K063558 | Peak Se, Model 5135KLE · Special | Ultradent Products, Inc. | 12/14/2006SE |
| K063557 | Peak Bond, Model 5133KLE · Special | Ultradent Products, Inc. | 12/12/2006SE |
| K063062 | Hkbond 2006KLE · Traditional | Heraeus Kulzer, Inc. | 12/01/2006SE |
| K062713 | Adhesive DC ActivatorKLE · Traditional | Ivoclar Vivadent, Inc. | 11/02/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | Premier Dental Products Co. | 10/04/2006SE |
| K062382 | Clearfil DC BondKLE · Traditional | Kuraray Medical, Inc. | 09/27/2006SE |
| K061611 | Bosworth Dentin ResinKLE · Traditional | Harry J. Bosworth Co. | 09/11/2006SE |
| K060882 | Excel Bond DC, Model 28-200100KLE · Traditional | J. Morita USA, Inc. | 09/01/2006SE |
| K061981 | SurpassKLE · Abbreviated | Apex Dental Materials, Inc. | 07/31/2006SE |
| K061322 | Porcelain PrimerKLE · Traditional | J. Morita USA, Inc. | 06/02/2006SE |
| K060684 | Adper Prompt, Adper Prompt L-PopKLE · Traditional | 3M Espe AG Dental Products | 04/24/2006SE |
| K060469 | Optibond All-In-OneKLE · Traditional | Sybron Dental Specialties, Inc. | 03/28/2006SE |
| K053103 | InterfaceKLE · Abbreviated | Apex Dental Materials, Inc. | 02/01/2006SE |
| K053392 | Futurabond NR Single DoseKLE · Special | Voco GmbH | 12/15/2005SE |
| K052699 | Versa-Link Porcelain Bonding SystemKLE · Traditional | Sultan Chemists, Inc. | 11/16/2005SE |
| K052501 | Multiple Resin Tooth Bonding AgentKLE · Traditional | Cosmedent, Inc. | 10/21/2005SE |
| K052189 | Reveneer Ceramic Repair SystemKLE · Traditional | Schutz-Dental GmbH | 10/17/2005SE |
| K051796 | Clearfil Tri-S Bond Single DoseKLE · Traditional | Kuraray Medical Kurashiki Plant | 08/09/2005SE |
| K051707 | Eclipse Bonding AgentKLE · Special | Dentsply Intl. | 07/15/2005SE |
| K051463 | Xeno Adhesive with ActivatorKLE · Traditional | Dentsply Intl. | 07/12/2005SE |
| K051050 | Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G, Models…KLE · Traditional | Schutz-Dental GmbH | 06/29/2005SE |
| K051006 | Ibond Next GenerationKLE · Traditional | Heraeus Kulzer,GmbH | 06/07/2005SE |
| K050647 | All-In-OneKLE · Traditional | Bisco, Inc. | 04/20/2005SE |
| K050331 | Adhesive 1KLE · Traditional | Southern Dental Industries, Inc. | 03/24/2005SE |
| K043170 | Bosworth BondKLE · Traditional | Harry J. Bosworth Co. | 02/25/2005SE |
| K050386 | Prime & Bond NT Dual Cure Nano-Technology Universal Dental Adhesive SystemKLE · Special | Dentsply International | 02/23/2005SE |
| K043043 | Hermes Bond 2KLE · Traditional | 3M Espe AG Dental Products | 01/10/2005SE |
| K043562 | BC PlusKLE · Traditional | Vericom Co., Ltd. | 01/03/2005SE |
| K042913 | Clearfil Tri-S BondKLE · Traditional | Kuraray Medical, Inc. | 11/26/2004SE |
| K042806 | Quadrant UNIT-1-BONDKLE · Traditional | Cavex Holland BV | 11/24/2004SE |
| K042614 | S&C-Self Etch Pr-BondKLE · Traditional | S & C Polymer GmbH | 11/22/2004SE |
| K041680 | Orajel Advanced Tooth DesensitizerKLE · Traditional | Del Pharmaceuticals, Inc. | 11/10/2004SE |
| K042670 | Futurabond NRKLE · Traditional | Voco GmbH | 11/01/2004SE |
| K040079 | M.L. PrimerKLE · Traditional | Shofu Dental Corp. | 09/09/2004SE |
| K041960 | Composite/Compomer Repair KitKLE · Abbreviated | Dmg USA, Inc. | 08/30/2004SE |
| K041471 | G-BondKLE · Traditional | GC America, Inc. | 06/29/2004SE |
| K040952 | PreludeKLE · Traditional | Danville Materials, Inc. | 06/29/2004SE |
| K041343 | Xeno NM Light Cured Dental AdhesiveKLE · Traditional | Dentsply International | 06/16/2004SE |
| K040857 | Modification to Adper PromptKLE · Traditional | 3M Espe AG Dental Products | 05/10/2004SE |
| K033974 | Hermes BondKLE · Traditional | 3M Espe AG Dental Products | 02/06/2004SE |
| K033938 | Clearfil Protect BondKLE · Traditional | Kuraray Medical, Inc. | 01/29/2004SE |
| K033760 | One Coat Se BondKLE · Traditional | Coltene/Whaledent, Inc. | 01/23/2004SE |
| K032953 | Embrace Wetbond Restoration and PFM Repair KitKLE · Traditional | Pulpdent Corporation | 12/10/2003SE |
| K032626 | Permaquick Se Bonding SystemKLE · Traditional | Ultradent Products, Inc. | 12/03/2003SE |
| K032179 | Comp. EKLE · Traditional | Parkell, Inc. | 09/09/2003SE |
| K031915 | Pulpdent Etch-Rite RoyaleKLE · Traditional | Pulpdent Corporation | 08/05/2003SE |
| K031444 | Optibond FLKLE · Traditional | Kerr Dental Materials Center | 07/02/2003SE |
| K030844 | Final Varnish LCKLE · Traditional | Voco GmbH | 06/13/2003SE |
| K030743 | Etchant 40%KLE · Traditional | Confi-Dental Products Co. | 05/09/2003SE |
| K024356 | Clearfil Silane KitKLE · Traditional | Kuraray Medical, Inc. | 03/26/2003SE |
| K023842 | Clearfil Se Bond PlusKLE · Traditional | Kuraray Medical, Inc. | 02/11/2003SE |
| K023776 | Xeno III Dental AdhesiveKLE · Traditional | Dentsply Intl. | 01/23/2003SE |
| K022973 | Adhesive 14KLE · Traditional | Ab Ardent | 11/22/2002SE |
| K023042 | PQ1KLE · Traditional | Ultradent Products, Inc. | 10/28/2002SE |
| K022612 | Ibond Gluma InsideKLE · Traditional | Heraeus Kulzer, Inc. | 10/28/2002SE |
| K021427 | Clearfil SA PrimerKLE · Traditional | Kuraray Medical, Inc. | 06/07/2002SE |
| K020514 | Pulpdent Glaze IIKLE · Traditional | Pulpdent Corporation | 05/16/2002SE |
| K020570 | SimplicityKLE · Traditional | Apex Dental Materials, Inc. | 04/24/2002SE |
| K020499 | BOND-3 AdhesiveKLE · Traditional | Jeneric/Pentron, Inc. | 04/22/2002SE |
| K020303 | XR Primer 2KLE · Traditional | Kerr Dental Materials Center | 04/19/2002SE |
| K020946 | Adper PromptKLE · Special | 3M Espe AG Dental Products | 04/04/2002SE |
| K020239 | Touch&Bond-PlusKLE · Traditional | Parkell, Inc. | 03/20/2002SE |
| K014027 | Optibond Solo Plus 4KLE · Traditional | Kerr Dental Materials Center | 02/22/2002SE |
| K013543 | BOND-1 C & BKLE · Traditional | Jeneric/Pentron, Inc. | 02/22/2002SE |
| K013997 | Unifil BondKLE · Traditional | GC America, Inc. | 02/20/2002SE |
| K020050 | Enamel Bonding SystemKLE · Traditional | Rite-Dent Manufacturing Corp. | 02/14/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0797-2025 Class II | 3M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit…Due to an increase of complaints for bracket bond failures and skin irritation or blistering. | 3M Unitek Corporation | 11/26/2024Open, Classified |
| Z-1368-2022 Class II | Peak Universal Bond Self-Etch Bottle Kit, Part: 4541; Peak Universal Bond Self-Etch…SE primer may be missing some or all of the resin portion of the chemistry. The absence of resin may impact… | Ultradent Products, Inc. | 06/01/2022Completed |
| Z-0741-2018 Class II | Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock…Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the… | Cosmedent, Inc. | 09/28/2017Terminated |
| Z-0955-2017 Class II | VOCO Futurabond M+ adhesive, RF 1515, Manufactured by VOCO GmbH, Futurabond M+ is a…Labeling mix-up: Futurabond M+ DCA (Dual Cure Activator) was marked labeled as Futurabond M+ Universal… | Voco GmbH | 11/03/2016Terminated |
| Z-2129-2014 Class II | Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is used to…Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Novocol, Inc. | 07/16/2014Terminated |
| Z-2128-2014 Class II | Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains 50 0.125 mL…Septodont is recalling Self-Etch bond because the material was incorrectly packaged. | Novocol, Inc. | 07/16/2014Terminated |
| Z-1822-2012 Class II | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South…Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012… | Ultradent Products, Inc. | 05/24/2012Terminated |
| Z-1142-2012 | Brand name: Bond-1 Primer/Adhesive, a resin tooth bonding agent. Item # Item Description…The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive… | Kerr Corporation | 05/27/2010Terminated |
| Z-1150-2010 | Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various…Some of the material has been found to be gelled and therefore becomes unusable. | Sybron Dental Specialties | 08/24/2009Terminated |
| Z-0036-2008 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive…The material may solidify in the bottle, and thus be rendered unusable. | Heraeus Kulzer Inc., Dental Products Division | 07/09/2007Terminated |
| Z-0035-2008 | Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive…The material may solidify in the bottle, and thus be rendered unusable. | Heraeus Kulzer Inc., Dental Products Division | 07/09/2007Terminated |