Prosthetic devices · 21 CFR 872 Subpart D
Resin Tooth Bonding Agent
FDA device type “Agent, Tooth Bonding, Resin”.
- Companies listing it
- 11571 makers
- Brands and models
- 420
- 510(k) clearances
- 42131 in five years
- FDA name
- Agent, Tooth Bonding, Resin
510(k) clearances per year, 1976–2026
Companies that list KLE
115 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Lucitone Digital Print for Primeprint · Prine & Bond NT DC Nano-Tech · Self-Cure · Self-Cure Activator · +1 | 148 | 2026 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Com Kit · Any-Com Universal Kit · Any-Etch · Hi-Bond Universal | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Bonding Agent · EsBond · FineEtch · K-Bond Universal | 22 | 2026 |
| Voco GmbH | Germany | Maker | Final Varnish LC · Futurabond DC · Futurabond DC Single Dose · Futurabond M · +6 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | HF-Etchant Hydrofluoric Acid Etching Gel · Light Cure Dental Adhesive · Phosphoric Acid Etching Gel · TopCEM Ceramic Primer Ceramic Coupling Agent | 13 | 2025 |
| DiaDent Group International | South Korea | Maker | DIA-X BOND Universal · DIAFIL START KIT · DiaPlus | 24 | 2026 |
| Shofu Inc | Japan | Maker | BEAUTIBOND · BEAUTIBOND UNIVERSAL · BEAUTIBOND XTREME · BEAUTICEM VENEER KIT · +7 | 96 | 2025 |
| GC America Inc. | United States | Maker | BZF-29 · Cavity Conditioner · FUJI BOND LC · G-2 Bond Universal Kit · +11 | 137 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | Biosplint Adhesive · Bond 1 SF · Bond-1 Dual Cure Activator · Bond-1 Primer & Adhesive · +16 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Peak SE · Peak Universal Bond · Peak-ZM · PermaFlo DC · +1 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Gluma Comfort Bond + Desensitizer · Gluma Desensitizer · Gluma Etch 35 Gel · iBond Etch 35 Gel · +4 | 37 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | BU6 | 23 | 2025 |
| Prevest Denpro Limited | India | Maker | Fusion Bond 5 · Fusion Bond 7 · Fusion Bond DC · Renew MDP · +1 | 7 | 2024 |
| Ivoclar Vivadent, AG | United States | Maker | Adhese 100 · Adhese 2 · Adhese 2 100 · Adhese Universal · +11 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | ALLOY PRIMER · CLEARFIL CERAMIC PRIMER PLUS · CLEARFIL DC Activator · CLEARFIL LINER BOND 2V · +14 | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | Bondsaver · Bondsaver D · Clean and Boost · Clean and Boost Gel · +13 | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | One Coat 7 Universal | 5 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | EZ Bond Universal · Meta P&Bond | 24 | 2024 |
| Liaoning Upcera Co., Ltd | China | Maker | Ceramic Etchant (HF-5 and HF-9) | 10 | 2026 |
| Deltamed GmbH | Germany | Maker | ACRIFIX Bonder · Insure® Silanator · PRO Resins Base X · PRO Resins Denture Bond · +4 | 6 | 2024 |
| Saremco Dental AG | Switzerland | Maker | els unibond | 4 | 2025 |
| American Orthodontics | United States | Maker | Acid Etchant · BracePaste MTP Light Cure Primer · BracePaste Prime Plus | 44 | 2026 |
| Premier Dental Products Company | United States | Maker | BOND BOOST SE · Bond-PR · Premier Ceramic Primer · Premier Spot-On Etch | 28 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Maker | — | 14 | 2026 |
| Sdi Limited | Australia | Maker | Adhesive 1 · Alloybond · Bonding Resin · Etchant liquid · +8 | 8 | 2022 |
| Bisco, Inc. | United States | Maker | ALL-BOND 2 · ALL-BOND 3 · ALL-BOND 3 RESIN · ALL-BOND UNIVERSAL · +13 | 88 | 2025 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | — | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | Ambar APS · Ambar Universal APS | 10 | 2024 |
| Den-Mat Holdings, LLC | United States | Maker | BondLink · G-BLOCK · G5 · G5 All-Purpose Desensitizer · +9 | 8 | 2026 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | VMLC Primer | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | EtchPro Etching Gel · PacBond One | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | 5 | 2022 |
| DMP Dental Industry S.A. | Greece | Maker | MagnaBond Universal, MagnaBond Universal DCA, MagnaBond SE · SINGLE BONDING | 3 | 2026 |
| Elevate Oral Care | United States | Maker | PapaCarie Duo | 3 | 2024 |
| Keystone Industries | United States | Maker | Bosworth Acid Etch · Seity Etchant Gel | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| Sincera Technology (changchun) Co., Ltd | China | Maker | Light Cure Adhesive | 2 | 2024 |
| Coltene/Whaledent AG | Switzerland | Maker | A.R.T. Bond · NE Self Etch Bond Plus 5ml · NE Total Etch Bond 5ml · One Coat 7 · +6 | 45 | 2022 |
| J. Morita USA, Inc. | United States | Maker | Max Bond LC Self-etching Bonding Agent | 42 | 2022 |
| Tp Orthodontics, Inc. | United States | Maker | — | 5 | 2022 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | DMG Etching Gel Jumbo · DMG Etching Gel Medium Viscosi · LuxaBond Pre-Bond Refill · LuxaBond Total Etch USA · +5 | 4 | 2022 |
| Sino-Dentex Co., Ltd. | China | Maker | — | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | DenTASTIC Adhesive Primers A, B & C · DenTASTIC Adhesive System · DenTASTIC Unfilled Resin Bonding Agent · DenTASTIC Unfilled Resin Bonding Agents 1 & 2 · +9 | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Porcelain Primer | 73 | 2020 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Reliance S.E.P. · S.E.P. · Self Etching Primer · Ultra SEP | 32 | 2021 |
| Cavex Holland BV | Netherlands | Maker | Quadrant Uni-1-Bond | 26 | 2015 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Tokuyama Dental Corporation | Japan | Maker | Estelite Sigma Introductory Kit · One-Up Bond F Plus · Tokuso Rebase Mr. Bond · Tokuyama Bond Force · +3 | 19 | 2021 |
| CAO Group, Inc. | United States | Maker | BlissBond · BlissEtch · FastFix | 13 | 2020 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Chemical Cure Composite Restorative Material · Prime-Dent Chemical Cure Dentin/Enamel Bonding Adhesive | 9 | 2012 |
| ITENA Clinical | France | Maker | AGENT, TOOTH BONDING, RESIN | 8 | 2017 |
| Schutz Dental GmbH | Germany | Maker | — | 7 | 2016 |
| Nobio Ltd. | Israel | Maker | Infinix Universal bond | 5 | 2020 |
| Silmet , Ltd. | Israel | Maker | ProEtch · ProLink · ProLink Block · ProLink Cem · +9 | 3 | 2011 |
| Advanced Healthcare , Ltd. | United Kingdom | Maker | A59-0042 · A59-0044 · Vivid Total Bond SE | 3 | 2003 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Bond · Alpha-Bond SE · Alpha-Ease · Alpha-Etch 37 · +1 | 2 | 2013 |
| Temrex Corp. | United States | Maker | SNAP BOND DENTIN ADHESIVE | 2 | 2012 |
| Dharma Research, Inc. | United States | Maker | ADS Etchant Gels · Jade Etchant Gels · Sherbet Etchant Gels | 1 | 2015 |
| DMG America, L.L.C. | United States | Maker | Agent, Tooth Bonding, Resin | 1 | 2013 |
| Biomat Sciences, Inc. | United States | Maker | Primagen | 1 | 1999 |
| B.J.M. Laboratories Ltd | Israel | Maker | Bond-PR Universal Adhesive · BondBoost SE · Premier Ceramic Primer · Premier Etch · +7 | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA DC Nano-reinforced Self-etch Bond · IDENTA LC Nano-reinforced Self-etch Bond · IDENTA LC Nano-reinforced Self-etch One-component Bond · IDENTA Universal Bond Plus | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| medmix Deutschland GmbH | Germany | Maker | GLUMA DESENSITIZER/GLUMA 3 PRIMER · IBOND TOTAL ETCH · iBond Universal & iBond Ceramic Primer · Prelude One UD | — | — |
| Leixir Resources Private Limited | India | Maker | Lucitone Digital Print Denture System | — | — |
| Beutlich Pharmaceuticals, LLC | United States | Maker | HurriSeal | — | — |
| F & A laboratorio Farmaceutico Ltda | Brazil | Maker | PapaCarie Duo | — | — |
| HealthDentl LLC | United States | Maker | Hema Benz · Hema Glu | — | — |
| MANI Medical Germany GmbH | Germany | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | Glidewell Zirconia Primer | 56 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | DESENSITIZER 10ML · ETCH-GEL 38% KIT | 23 | 2025 |
| Centrix, Inc. | United States | Contract manufacturer | Glu/sense | 44 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Complete Unfilled Resin · Silanator | 27 | 2024 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | EDS Self Etch Bonding Agent | 15 | 2023 |
| Dent Zar, Inc. | United States | Repacker / relabeler | SELF CURE BONDING AGENT | 12 | 1996 |
| Rmo, Inc. | United States | Manufacturer | TruLock Conditioner | 1 | 1990 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | Assure Plus · Assure Universal Bonding Resin · Primer · Transbond lollypops · +2 | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | ADHESE UNIVERSAL · ADPER PROMPT, ADPER PROMPT L-POP · AGENT, TOOTH BONDING, RESIN · BeautiBond · +18 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Bond · Bonding · dental · dental bond · +5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Phosphoric Acid Etching Gel, 37% · RESIN · Universal Light Cure Dental Adhesive | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | AGENT, TOOTH BONDING, RESIN · Patterson Tooth Bonding Resin | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Bond · Bonding · dental bond · dental bonding · +6 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Adper L Pop · Cavity Conditioner · Clearfil Bond · G-Bond · +6 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Durabond | — | — |
| Premium Plus Dental | United States | Lister | Agent, Tooth Bonding , Resin · AGENT, TOOTH BONDING ,RESIN · Stela Automix System | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-X BOND Universal · DIAETCH · DIAFIL START KIT · DiaPlus | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Agent, Tooth Bonding · Cavity Conditioner · Microprime | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Adhesive Bracket and Tooth Conditioner Resin · Tooth Bonding Resin | — | — |
| Bina Limited | Belize | Foreign exporter | DENTAL BOND | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | Ceramic Etchant (HF-5 and HF-9) | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Signa Medical, Inc. | United States | Repacker / relabeler | BondLink; Gloss 'N' Seal; LumiBrite Desensitizing Enhancer; Tenure Quik with Fluoride; Tenure S; Tenure Uni-Bond · TOOTH BONDING AGENT | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | 3M ESPE | — | — |
| Sanicure BV | Netherlands | Foreign exporter | AGENT, TOOTH BONDING, RESIN · Material, tooth shade, resin | — | — |
| Zapalign LLC | United States | Repacker / relabeler | AGENT, TOOTH BONDING, RESIN · EBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESIN | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | MPa Universal Adhesive | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | AGENT, TOOTH BONDING, RESIN | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | — | — | — |
| HEXA Dental | United States | Contract manufacturer | — | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | BEAUTIBOND | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| The Atlanta Dental supply Company | United States | Repacker / relabeler | — | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| EdelweissDR AG | Switzerland | Repacker / relabeler | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| MHM Grupo Diamante, S.A. de C.V. | Mexico | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Zircon Plus Limited | Israel | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 8 Oct 2026 | K263680 | One Coat Bond; One Coat Bond SL | Dent4You AG |
| 24 Sep 2026 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC |
| 14 May 2026 | K260485 | Any-Etch | Mediclus Co., Ltd |
| 10 Apr 2026 | K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak |
| 5 Mar 2026 | K252450 | Adhese 2 | Ivoclar Vivadent, AG |
| 3 Mar 2026 | K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company |
| 23 Feb 2026 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. |
| 5 Dec 2025 | K252151 | els unibond | Saremco Dental AG |
| 6 Nov 2025 | K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | DMP Dental Industry S.A. |
| 2 Oct 2025 | K251124 | G-Bond Universal | GC America Inc. |
| 20 Dec 2024 | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao HuGe Biomaterials Company, Ltd. |
| 8 Nov 2024 | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao HuGe Biomaterials Company, Ltd. |
| 1 Nov 2024 | K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. |
| 2 Oct 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd |
| 22 Jul 2024 | K241445 | K-Bond Universal | Spident Co., Ltd. |
| 16 Jul 2024 | K241056 | Light Cure Adhesive | Sincera Technology (changchun) Co., Ltd |
| 20 Mar 2024 | K240743 | Peak Universal Bond | Ultradent Products, Inc. |
| 13 Dec 2023 | K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. |
| 22 Sep 2023 | K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. |
| 11 Aug 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited |
| 22 May 2023 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd |
| 3 Mar 2023 | K230009 | EZ Bond Universal | Meta Biomed Co, Ltd |
| 12 Jan 2023 | K222830 | Rainbow 360 | Sybron Dental Specialties |
| 12 Sep 2022 | K221450 | Phosphoric Acid Etching Gel | Rizhao HuGe Biomaterials Company, Ltd. |
| 9 Aug 2022 | K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC |
| 6 Jul 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitaten GmbH |
| 15 Jun 2022 | K220804 | Dia-X Bond Universal | DiaDent Group International |
| 7 Jun 2022 | K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG |
| 18 Mar 2022 | K213965 | BeautiBond Xtreme | Shofu Inc |
| 31 Jan 2022 | K213401 | DIAPLUS Universal | DiaDent Group International |
| 28 Jan 2022 | K213093 | STEP-1 PumEtch | Rounding Third, LLC |
| 16 Jul 2021 | K210186 | PacBond One | Pac-Dent Inc. |
| 8 Jul 2021 | K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. |
| 25 May 2021 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation |
| 19 Jan 2021 | K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS |
| 28 Oct 2020 | K200153 | Bright Bond Universal | GENOSS Co., Ltd. |
| 2 Oct 2020 | K200682 | BZF-29 | GC America Inc. |
| 25 Sep 2020 | K201787 | Light Cure Dental Adhesive | Rizhao HuGe Biomaterials Company, Ltd. |
| 2 Sep 2020 | K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak |
| 26 May 2020 | K192392 | DiaPlus | DiaDent Group International |
| 7 Feb 2020 | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | DiaDent Group International |
| 13 Dec 2019 | K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda |
| 2 Dec 2019 | K191656 | Zipbond | Sdi Limited |
| 31 Oct 2019 | K192961 | ADH19 | 3M Deutschland GmbH |
| 9 Oct 2019 | K191523 | Visalys Restorative Primer | Kettenbach GmbH & Co. KG |
| 29 Sep 2019 | K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG |
| 24 Sep 2019 | K183391 | Novidia Universal Bond | Nobio Ltd. |
| 20 Nov 2018 | K180917 | GC Acrylic Primer | GC America Inc. |
| 7 Nov 2018 | K182162 | OptiBond eXTRa Universal | Sybron Dental Specialties |
| 15 Oct 2018 | K181910 | BracePaste MTP Light Cure Primer | American Orthodontics |
| 28 Sep 2018 | K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona, Inc. |
| 26 Sep 2018 | K180803 | BeautiBond Universal | Shofu Inc |
| 29 Aug 2018 | K180802 | Meta P&Bond | Meta Biomed Co, Ltd |
| 6 Feb 2018 | K172953 | Acid Etchant | American Orthodontics |
| 16 Jan 2018 | K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | Nanova Biomaterials Inc |
| 28 Nov 2017 | K171226 | TOKUYAMA UNIVERSAL BOND | Tokuyama Dental Corporation |
| 21 Nov 2017 | K172176 | Parkell Universal Adhesive | Parkell, Inc |
| 31 Aug 2017 | K172106 | SHOFU MZ Primer Plus | Shofu Inc |
| 17 Mar 2017 | K161077 | RnD TE and RnD SE | Apex Dental Materials, Inc. |
| 21 Nov 2016 | K161891 | HC Primer | Shofu Inc |
| 25 Oct 2016 | K161042 | CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack | Kuraray Noritake Dental, Inc. |
| 9 Sep 2016 | K161051 | All-Bond Universal w/BAC (not finalized) | Bisco, Inc. |
| 9 Dec 2015 | K152243 | One Coat 7 Universal | Coltene/Whaledent AG |
| 20 Nov 2015 | K152110 | e-1 etchants | E Dental Products |
| 30 Oct 2015 | K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. |
| 18 Sep 2015 | K151518 | BRUSH&BOND PLUS | Parkell, Inc |
| 13 Aug 2015 | K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | Kuraray Noritake Dental, Inc. |
| 7 Jul 2015 | K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC (Mitsui Chemicals Group) |
| 23 Jun 2015 | K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. |
| 20 Apr 2015 | K143140 | G-Premio BOND | GC America Inc. |
| 3 Apr 2015 | K150164 | Monobond Etch & Prime | Ivoclar Vivadent, AG |
| 24 Feb 2015 | K142848 | EAZY PRIMER | Parkell, Inc |
| 17 Nov 2014 | K141839 | PREMIER ETCH | Premier Dental Products Company |
| 20 Aug 2014 | K140537 | TENURE4G | Den-Mat Holdings, LLC |
| 1 Aug 2014 | K141610 | FUTURABOND M+ | Voco GmbH |
| 11 Apr 2014 | K131734 | ALL-BOND UNIVERSAL SC (NOT FINALIZED) | Bisco, Inc. |
| 11 Feb 2014 | K133318 | ADHESE UNIVERSAL | Ivoclar Vivadent, AG |
| 3 Jan 2014 | K132923 | FUSION SINGLE LINK | Angelus Industria DE Produtos Odontologicos S/A |
| 20 Dec 2013 | K133078 | K-ETCHANT SYRINGE; NEEDLE TIP (E) | Kuraray Noritake Dental, Inc. |
| 1 Nov 2013 | K132450 | CLEARFIL UNIVERSAL BOND VALUE PACK, CLEARFIL UNIVERSALY BOND TRIAL, CLEARFIL UNIVERSAL BOND | Kuraray Noritake Dental, Inc. |
| 10 Sep 2013 | K131043 | APEX UNIVERSAL ADHESIVE | Apex Dental Materials, Inc. |
| 6 Sep 2013 | K131357 | PEAK Z | Ultradent Products, Inc. |
| 30 Aug 2013 | K131430 | CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL | Kuraray Noritake Dental, Inc. |
| 27 Aug 2013 | K131049 | ZRP | Apex Dental Materials, Inc. |
| 26 Aug 2013 | K131212 | PREMIER CERAMIC PRIMER | Premier Dental Products Company |
| 22 Aug 2013 | K131432 | CLEARFIL SE BOND 2 KIT; CLEARFIL SE BOND 2 VALUE PACK; CLEARFIL SE BOND 2 TRIAL PACK; CLEARFIL SE BOND 2 BOND; CLEARFIL | Kuraray Noritake Dental, Inc. |
| 11 Jul 2013 | K131248 | ETCH GEL | DMG America, L.L.C. |
| 20 Jun 2013 | K130486 | FUTURABOND UNIVERSAL | Voco GmbH |
| 19 Mar 2013 | K122522 | DENTOETCH QUICKBOND BOND ACTIVATOR | ITENA Clinical |
| 7 Dec 2012 | K123278 | IBOND SELF ETCH BOTTLE ASSORTMENT, IBOND SELF ETCH BOTTLE VALUE PACK, IBOND SELF ETCH SINGLE DOSE ASSORTMENT, IBOND SELF | Heraeus Kulzer, LLC |
| 28 Nov 2012 | K123119 | CERARESIN BOND | Shofu Inc |
| 31 May 2012 | K120620 | CLEAN AND BOOST | Apex Dental Materials, Inc. |
| 24 May 2012 | K120767 | ES BOND | Spident Co., Ltd. |
| 30 Mar 2012 | K120213 | ETCH-RITE SUPREME | Pulpdent Corporation |
| 7 Dec 2011 | K112597 | SEITY 37% PHOSPHORIC ACID ETCHANT GEL | Mycone Dental Supply Co., Inc. |
| 17 Nov 2011 | K112118 | DREAMBOND | Bisco, Inc. |
| 14 Oct 2011 | K111980 | CLEARFIL TRI-S BOND PLUS | Kuraray America, Inc. |
| 14 Oct 2011 | K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK | Kuraray Medical, Inc. |
| 21 Sep 2011 | K111876 | Z BOND, PRELUDE ONE | Danville Materials, LLC |
| 8 Sep 2011 | K110403 | PROLINK ADHESIVES (PROLINK, PROLINK SE) | Silmet , Ltd. |
| 1 Aug 2011 | K111431 | B1P ADHESIVE | Pentron Clinical |
| 19 May 2011 | K110302 | ADHESIVE EXL-759 | 3M Espe AG |
| 13 May 2011 | K110252 | BEAUTIBOND MULTI PR PLUS | Shofu Inc |
| 13 May 2011 | K110235 | BEAUTIBOND MULTI | Shofu Inc |
| 23 Nov 2010 | K102254 | DMP SINGLE BONDING | Dmp, Ltd. |
| 29 Oct 2010 | K102844 | ALL-BOUND 3 | Bisco, Inc. |
| 26 Aug 2010 | K101485 | ALL-ETCH, ALL- ETCH WITH BAC; UNI- ETCH, UNI- ETCH WITH BAC; ETCH- 37, ETCH- 37 WITH BAC; DARK- ETCH, DARK ETCH (BLUE- E | Bisco, Inc. |
| 30 Jul 2010 | K101423 | OPTIBOND XTR | Sybron Dental Specialties |
| 16 Jul 2010 | K100752 | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) | Ultradent Products, Inc. |
| 30 Apr 2010 | K100347 | OPTIBOND SE | Sybron Dental Specialties |
| 16 Apr 2010 | K093014 | AMERICAN DENTAL PRODUCTS SE BONDEASY | American Dental Products, Inc. |
| 10 Mar 2010 | K093744 | EXCITE F AND EXCITE DSC | Ivoclar Vivadent, AG |
| 21 Oct 2009 | K092616 | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 | CAO Group, Inc. |
| 28 Aug 2009 | K091705 | PRIMER PLUS | Bisco, Inc. |
| 23 Jul 2009 | K091300 | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 | CAO Group, Inc. |
| 17 Jul 2009 | K090941 | ADHESE ONE F | Ivoclar Vivadent, AG |
| 11 May 2009 | K090826 | MONOBOND PLUS | Ivoclar Vivadent, AG |
| 31 Mar 2009 | K090106 | PRELUDE ONE | Danville Materials, LLC |
| 21 Jan 2009 | K083652 | IBOND TOTAL ETCH | Heraeus Kulzer, LLC |
| 11 Dec 2008 | K082744 | BEAUTIBOND | Shofu Inc |
| 24 Nov 2008 | K082753 | FUTURABOND M/FUTURABOND M SINGLE DOSE | Voco GmbH |
| 21 Oct 2008 | K082768 | G-BOND PLUS | GC America Inc. |
| 21 Nov 2007 | K072480 | GENERATION 8 SE ADHESIVE | Pentron Clinical Technologies |
| 7 Sep 2007 | K071688 | RELIANCE S.E.P. | Reliance Orthodontic Products, Inc. |
| 10 Aug 2007 | K071500 | NANO-BOND II ADHESIVE SYSTEM | Pentron Clinical Technologies |
| 25 Jul 2007 | K071131 | UNO | 3M Espe AG Dental Products |
| 17 Jul 2007 | K071260 | HERMES BOND 3 | 3M Espe AG Dental Products |
| 9 Jul 2007 | K071452 | FL BOND II | Shofu Inc |
| 7 Jun 2007 | K070723 | FUTURABOND DC/SINGLE DOSE | Voco GmbH |
| 22 May 2007 | K070956 | SEA2 SELF ETCH ADHESIVE | 3M Espe Dental Products |
| 11 May 2007 | K070646 | ADHESE ONE | Ivoclar Vivadent, AG |
| 26 Apr 2007 | K070413 | ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 | CAO Group, Inc. |
| 30 Mar 2007 | K070215 | TOKUYAMA BOND FORCE | Tokuyama Dental Corporation |
| 20 Mar 2007 | K063444 | TOTAL ETCH BONDING AGENT | Dmg USA, Inc. |
| 14 Mar 2007 | K070538 | XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE | Dentsply Intl., Inc. |
| 19 Jan 2007 | K063780 | ACE BOND SE | Bisco, Inc. |
| 14 Dec 2006 | K063558 | PEAK SE, MODEL 5135 | Ultradent Products, Inc. |
| 12 Dec 2006 | K063557 | PEAK BOND, MODEL 5133 | Ultradent Products, Inc. |
| 1 Dec 2006 | K063062 | HKBOND 2006 | Heraeus Kulzer, LLC |
| 2 Nov 2006 | K062713 | ADHESIVE DC ACTIVATOR | Ivoclar Vivadent, AG |
| 4 Oct 2006 | K061998 | PREMIER SELF-ETCHING BOND ENHANCER | Premier Dental Products Company |
| 27 Sep 2006 | K062382 | CLEARFIL DC BOND | Kuraray Medical, Inc. |
| 11 Sep 2006 | K061611 | BOSWORTH DENTIN RESIN | Harry J. Bosworth Co. |
| 1 Sep 2006 | K060882 | EXCEL BOND DC, MODEL 28-200100 | J. Morita USA, Inc. |
| 31 Jul 2006 | K061981 | SURPASS | Apex Dental Materials, Inc. |
| 2 Jun 2006 | K061322 | PORCELAIN PRIMER | J. Morita USA, Inc. |
| 24 Apr 2006 | K060684 | ADPER PROMPT, ADPER PROMPT L-POP | 3M Espe AG Dental Products |
| 28 Mar 2006 | K060469 | OPTIBOND ALL-IN-ONE | Sybron Dental Specialties |
| 1 Feb 2006 | K053103 | INTERFACE | Apex Dental Materials, Inc. |
| 15 Dec 2005 | K053392 | FUTURABOND NR SINGLE DOSE | Voco GmbH |
| 16 Nov 2005 | K052699 | VERSA-LINK PORCELAIN BONDING SYSTEM | Sultan Chemists, Inc. |
| 21 Oct 2005 | K052501 | MULTIPLE RESIN TOOTH BONDING AGENT | Cosmedent, Inc. |
| 17 Oct 2005 | K052189 | REVENEER CERAMIC REPAIR SYSTEM | Schutz Dental GmbH |
| 9 Aug 2005 | K051796 | CLEARFIL TRI-S BOND SINGLE DOSE | Kuraray Medical Kurashiki Plant |
| 15 Jul 2005 | K051707 | ECLIPSE BONDING AGENT | Dentsply Intl., Inc. |
| 12 Jul 2005 | K051463 | XENO ADHESIVE WITH ACTIVATOR | Dentsply Intl., Inc. |
| 29 Jun 2005 | K051050 | SEBOND PINK LIGHT 5G, SEBOND PINK DARK 5G, SEBOND SMART 5ML, SEBOND GRIP 3G, MODELS 644090, 644091, 640066, 644092 | Schutz Dental GmbH |
| 7 Jun 2005 | K051006 | IBOND NEXT GENERATION | Heraeus Kulzer, LLC |
| 20 Apr 2005 | K050647 | ALL-IN-ONE | Bisco, Inc. |
| 24 Mar 2005 | K050331 | ADHESIVE 1 | Southern Dental Industries, Inc. |
| 25 Feb 2005 | K043170 | BOSWORTH BOND | Harry J. Bosworth Co. |
| 23 Feb 2005 | K050386 | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM | Dentsply International, Inc. |
| 10 Jan 2005 | K043043 | HERMES BOND 2 | 3M Espe AG Dental Products |
| 3 Jan 2005 | K043562 | BC PLUS | Vericom Co., Ltd. |
| 26 Nov 2004 | K042913 | CLEARFIL TRI-S BOND | Kuraray Medical, Inc. |
| 24 Nov 2004 | K042806 | QUADRANT UNIT-1-BOND | Cavex Holland BV |
| 22 Nov 2004 | K042614 | S&C-SELF ETCH PR-BOND | S & C Polymer GmbH |
| 10 Nov 2004 | K041680 | ORAJEL ADVANCED TOOTH DESENSITIZER | Del Pharmaceuticals, Inc. |
| 1 Nov 2004 | K042670 | FUTURABOND NR | Voco GmbH |
| 9 Sep 2004 | K040079 | M.L. PRIMER | Shofu Inc |
| 30 Aug 2004 | K041960 | COMPOSITE/COMPOMER REPAIR KIT | Dmg USA, Inc. |
| 29 Jun 2004 | K041471 | G-BOND | GC America Inc. |
| 29 Jun 2004 | K040952 | PRELUDE | Danville Materials, LLC |
| 16 Jun 2004 | K041343 | XENO NM LIGHT CURED DENTAL ADHESIVE | Dentsply International, Inc. |
| 10 May 2004 | K040857 | MODIFICATION TO ADPER PROMPT | 3M Espe AG Dental Products |
| 6 Feb 2004 | K033974 | HERMES BOND | 3M Espe AG Dental Products |
| 29 Jan 2004 | K033938 | CLEARFIL PROTECT BOND | Kuraray Medical, Inc. |
| 23 Jan 2004 | K033760 | ONE COAT SE BOND | Coltene/Whaledent AG |
| 10 Dec 2003 | K032953 | EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT | Pulpdent Corporation |
| 3 Dec 2003 | K032626 | PERMAQUICK SE BONDING SYSTEM | Ultradent Products, Inc. |
| 9 Sep 2003 | K032179 | COMP. E | Parkell, Inc |
| 5 Aug 2003 | K031915 | PULPDENT ETCH-RITE ROYALE | Pulpdent Corporation |
| 2 Jul 2003 | K031444 | OPTIBOND FL | Kerr Dental Materials Center |
| 13 Jun 2003 | K030844 | FINAL VARNISH LC | Voco GmbH |
| 9 May 2003 | K030743 | ETCHANT 40% | Confi-Dental Products Co. |
| 26 Mar 2003 | K024356 | CLEARFIL SILANE KIT | Kuraray Medical, Inc. |
| 11 Feb 2003 | K023842 | CLEARFIL SE BOND PLUS | Kuraray Medical, Inc. |
| 23 Jan 2003 | K023776 | XENO III DENTAL ADHESIVE | Dentsply Intl., Inc. |
| 22 Nov 2002 | K022973 | ADHESIVE 14 | Ab Ardent |
| 28 Oct 2002 | K023042 | PQ1 | Ultradent Products, Inc. |
| 28 Oct 2002 | K022612 | IBOND GLUMA INSIDE | Heraeus Kulzer, LLC |
| 7 Jun 2002 | K021427 | CLEARFIL SA PRIMER | Kuraray Medical, Inc. |
| 16 May 2002 | K020514 | PULPDENT GLAZE II | Pulpdent Corporation |
| 24 Apr 2002 | K020570 | SIMPLICITY | Apex Dental Materials, Inc. |
| 22 Apr 2002 | K020499 | BOND-3 ADHESIVE | Jeneric/Pentron, Inc. |
| 19 Apr 2002 | K020303 | XR PRIMER 2 | Kerr Dental Materials Center |
| 4 Apr 2002 | K020946 | ADPER PROMPT | 3M Espe AG Dental Products |
| 20 Mar 2002 | K020239 | TOUCH&BOND-PLUS | Parkell, Inc |
| 22 Feb 2002 | K014027 | OPTIBOND SOLO PLUS 4 | Kerr Dental Materials Center |
| 22 Feb 2002 | K013543 | BOND-1 C & B | Jeneric/Pentron, Inc. |
Showing the 200 most recent of 421.
Official records: FDA product classification for KLE · 21 CFR 872.3200.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026