Bonding agents: manufacturers and brands
71 companies make or specify dental bonding agents among the 115 that list one with FDA, under 420 brand and model names. FDA has issued 421 510(k) clearances in this category, 31 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental bonding agent manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| 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 | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental bonding agents are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Resin Tooth Bonding AgentKLE | 2 | 872.3200 | 71 | 421 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Oct 2026 | K263680 | One Coat Bond; One Coat Bond SL | Dent4You AG | KLE Resin Tooth Bonding Agent |
| 24 Sep 2026 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | KLE Resin Tooth Bonding Agent |
| 14 May 2026 | K260485 | Any-Etch | Mediclus Co., Ltd | KLE Resin Tooth Bonding Agent |
| 10 Apr 2026 | K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | KLE Resin Tooth Bonding Agent |
| 5 Mar 2026 | K252450 | Adhese 2 | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 3 Mar 2026 | K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 23 Feb 2026 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | KLE Resin Tooth Bonding Agent |
| 5 Dec 2025 | K252151 | els unibond | Saremco Dental AG | KLE Resin Tooth Bonding Agent |
| 6 Nov 2025 | K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | DMP Dental Industry S.A. | KLE Resin Tooth Bonding Agent |
| 2 Oct 2025 | K251124 | G-Bond Universal | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 20 Dec 2024 | K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 8 Nov 2024 | K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 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. | KLE Resin Tooth Bonding Agent |
| 2 Oct 2024 | K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd | KLE Resin Tooth Bonding Agent |
| 22 Jul 2024 | K241445 | K-Bond Universal | Spident Co., Ltd. | KLE Resin Tooth Bonding Agent |
| 16 Jul 2024 | K241056 | Light Cure Adhesive | Sincera Technology (changchun) Co., Ltd | KLE Resin Tooth Bonding Agent |
| 20 Mar 2024 | K240743 | Peak Universal Bond | Ultradent Products, Inc. | KLE Resin Tooth Bonding Agent |
| 13 Dec 2023 | K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | KLE Resin Tooth Bonding Agent |
| 22 Sep 2023 | K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | KLE Resin Tooth Bonding Agent |
| 11 Aug 2023 | K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | KLE Resin Tooth Bonding Agent |
| 22 May 2023 | K230465 | Hi-Bond Universal | Mediclus Co., Ltd | KLE Resin Tooth Bonding Agent |
| 3 Mar 2023 | K230009 | EZ Bond Universal | Meta Biomed Co, Ltd | KLE Resin Tooth Bonding Agent |
| 12 Jan 2023 | K222830 | Rainbow 360 | Sybron Dental Specialties | KLE Resin Tooth Bonding Agent |
| 12 Sep 2022 | K221450 | Phosphoric Acid Etching Gel | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 9 Aug 2022 | K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | KLE Resin Tooth Bonding Agent |
| 6 Jul 2022 | K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | KLE Resin Tooth Bonding Agent |
| 15 Jun 2022 | K220804 | Dia-X Bond Universal | DiaDent Group International | KLE Resin Tooth Bonding Agent |
| 7 Jun 2022 | K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 18 Mar 2022 | K213965 | BeautiBond Xtreme | Shofu Inc | KLE Resin Tooth Bonding Agent |
| 31 Jan 2022 | K213401 | DIAPLUS Universal | DiaDent Group International | KLE Resin Tooth Bonding Agent |
| 28 Jan 2022 | K213093 | STEP-1 PumEtch | Rounding Third, LLC | KLE Resin Tooth Bonding Agent |
| 16 Jul 2021 | K210186 | PacBond One | Pac-Dent Inc. | KLE Resin Tooth Bonding Agent |
| 8 Jul 2021 | K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | KLE Resin Tooth Bonding Agent |
| 25 May 2021 | K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | KLE Resin Tooth Bonding Agent |
| 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 | KLE Resin Tooth Bonding Agent |
| 28 Oct 2020 | K200153 | Bright Bond Universal | GENOSS Co., Ltd. | KLE Resin Tooth Bonding Agent |
| 2 Oct 2020 | K200682 | BZF-29 | GC America Inc. | KLE Resin Tooth Bonding Agent |
| 25 Sep 2020 | K201787 | Light Cure Dental Adhesive | Rizhao HuGe Biomaterials Company, Ltd. | KLE Resin Tooth Bonding Agent |
| 2 Sep 2020 | K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | KLE Resin Tooth Bonding Agent |
| 26 May 2020 | K192392 | DiaPlus | DiaDent Group International | KLE Resin Tooth Bonding Agent |