Dental composites: manufacturers and brands
108 companies make or specify dental composites among the 175 that list one with FDA, under 1,181 brand and model names. FDA has issued 937 510(k) clearances in this category, 78 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental composite 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 | Adaptable Composite Resin · Comspan Cement · Esthet-X Easy Twist · Esthet-X Improved, · +11 | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | CAMouflage NOW Milling Blocks; GD-Mandrel; A1 HT; 14 (5 units) · CAMouflage NOW Milling Blocks; GD-Mandrel; A1 LT; 14 (5 units) · CAMouflage NOW Milling Blocks; GD-Mandrel; A2 HT; 14 (5 units) · CAMouflage NOW Milling Blocks; GD-Mandrel; A2 LT; 14 (5 units) · +10 | 56 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | C&B NFH Hybrid | 17 | 2025 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Com · Any-Com Bulk · Any-Com Flow · Any-Com Kit · +5 | 15 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Core It Dual · EsCom 100 · EsCom250 · EsFlow · +4 | 22 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additive Manufacturing (Light Curing) Crown Bridge Resin · Dental Ceramic Blocks · FREEPRINT crown · Light-curing Coloring Materials (ALCM) · +1 | 16 | 2026 |
| Voco GmbH | Germany | Maker | Admira · Admira Bond · Admira Caps · Admira Flow · +41 | 117 | 2026 |
| Rizhao HuGe Biomaterials Company, Ltd. | China | Maker | Dual Cure Resin Cement · TopCEM Dual Cure Resin Cement · TopCEM-Try in Veneer Try-in Gel · TopCEM-Veneer Light Cure Veneer Cement · +3 | 13 | 2025 |
| DiaDent Group International | South Korea | Maker | DIAFIL · DIAFIL Bulk FLOW · DIAFIL Capsule · DIAFIL Capsule Type · +2 | 24 | 2026 |
| Shofu Inc | Japan | Maker | BEAUTICEM VENEER KIT · BEAUTIFIL · BEAUTIFIL BULK · BEAUTIFIL BULK FLOWABLE · +28 | 96 | 2025 |
| SprintRay Inc. | United States | Maker | Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) · Crown HT (A1, A2, A3, B1, Unpigmented, Bleach) · Midas Restore (A1, A2, A3, B1, Bleach, Unpigmented, C2) · SprintRay Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) | 8 | 2026 |
| GC America Inc. | United States | Maker | Cerasmart · Cerasmart 270 · Cerasmart Universal · Diapolisher Paste · +43 | 137 | 2026 |
| Hiossen Inc. | United States | Maker | Smartfit Provisional Denture · Smartfit Try In Hybrid Denture | 26 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Sybron Dental Specialties | United States | Maker | Alert · Alert Condensable Composite · Artiste Nano Composite · Build-It FR · +39 | 203 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Amelogen Plus · Composite Wetting Resin · Forma S · J-Temp · +14 | 95 | 2026 |
| Kulzer, LLC | United States | Maker | Charisma · Charisma ABC · IBond Universal and iBond Ceramic Primer · PALA cre-active · +16 | 37 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | HFA0 · HFA1 · HFA2 · HFA3 · +18 | 23 | 2025 |
| Prevest Denpro Limited | India | Maker | Fusion Core DC Flo · Fusion Flo · Fusion Flo SE · Fusion I Seal · +4 | 7 | 2024 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | Dura-Crown · Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) · LumiCera | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Chairside Workflow 3D Printing · Heliomolar · Heliomolar Flow · Heliomolar Trans Shades · +40 | 94 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CLEARFIL AP-X · CLEARFIL AP-X PLT · CLEARFIL DC CORE PLUS · CLEARFIL MAJESTY ES Flow · +13 | 32 | 2025 |
| Inter-Med, Inc. | United States | Maker | Exquisite Restoration · Injectafil · Regen Bulk Fill Composite and Resin Cement · Regen Flowable Composite Liner · +4 | 7 | 2026 |
| Graphy, Inc. | South Korea | Maker | TERA HARZ · Tera Harz II | 6 | 2025 |
| Dent4You AG | Switzerland | Maker | BRILLIANT Bulk Fill Flow · BRILLIANT Crios · BRILLIANT EverGlow · BRILLIANT EverGlow Flow · +1 | 5 | 2026 |
| Meta Biomed Co, Ltd | United States | Maker | Ezfil · Jet Flow Bulk · Meta Etchant · Nexcomp · +1 | 24 | 2024 |
| Liaoning Upcera Co., Ltd | China | Maker | Hyramic CAD/CAM Restorative | 10 | 2026 |
| Deltamed GmbH | Germany | Maker | Brush & Sculpt · CosmeCore · Creative Color® Clear Liquid Resin · Creative Color® Opaquer · +14 | 6 | 2024 |
| Saremco Dental AG | Switzerland | Maker | els extra low shrinkage® composite · saremco print Crowntec | 4 | 2025 |
| Premier Dental Products Company | United States | Maker | CompCore AF · MultiMatch · MultiMatch Flow Chameleon AntiMicrobial Composite · Premier IntegraBond | 28 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Visalys BioCeramic Block · Visalys Bulk Fill · Visalys Bulk Flow | 14 | 2026 |
| Sdi Limited | Australia | Maker | Acid Etch gel · Acid Etch liquid · Aura · Aura Bulk Fill · +18 | 8 | 2022 |
| Harvest Dental Products, LLC | United States | Maker | EasyGum Composite Strip | 5 | 2023 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Flowable Restorative Material(KP-Flow LF, KP-Flow MF, KP-Flow HF) | 3 | 2026 |
| Bisco, Inc. | United States | Maker | AELITE AESTHETIC ENAMEL · AELITE ALL-PURPOSE BODY · AELITE LS PACKABLE DENTIN · AELITE LS PACKABLE ENAMEL · +25 | 88 | 2025 |
| Parkell, Inc | United States | Maker | — | 58 | 2025 |
| Centrix, Inc. | United States | Maker | Encore AF Natural W/Fluoride · Encore AF White w/Fluoride · Encore C-R Hybrid · Encore D/C · +11 | 44 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | DENFIL · DENFIL FLOW · SPACER | 20 | 2026 |
| Dentscare Ltda | Brazil | Maker | Allcem · Allcem Core · Allcem Veneer APS · Allcem Veneer Try-in · +8 | 10 | 2024 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Den-Mat Holdings, LLC | United States | Maker | Cerinate Shade Modification System · Core Paste · DenMat Bulk Fill · DenMat Tenure · +16 | 8 | 2026 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | ADIVA FCEM · VITA ENAMIC Blocks · VITA Vionic Dent Disc Resin · VM LC Flow · +1 | 8 | 2026 |
| Pac-Dent Inc. | United States | Maker | OptiComp · RapidCeram · Rodin 3D Ceramic Nanohybrid Resin · Rodin Sculpture 2 | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | Nova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe · Nova Compo HF, Othocompo, Luxera, Maritza · Nova Compo N, Nova Compo SF, Nova Compo O, Nova Compo C · Nova Compomer (Classic and Rainbow) · +1 | 5 | 2022 |
| DMP Dental Industry S.A. | Greece | Maker | BRIGHT FLOW CORE · BRIGHT LIGHT · BRIGHT LIGHT FLOW · BRIGHT POSTERIOR · +3 | 3 | 2026 |
| Detax GmbH | Germany | Maker | FREEPRINT® crown A3,5 1000g · FREEPRINT® crown A3,5 500g · VITA VIONIC® DENT RESIN 0M3 1000g · VITA VIONIC® DENT RESIN 0M3 500g · +16 | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | Ceramic Hybrid Resin · OptiFlow II · Rodin Titan 3d Resin · 23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle · +20 | 2 | 2026 |
| HDI Inc. | South Korea | Maker | DENU Composite Resin · DENU Flow Resin | 2 | 2022 |
| Clemde SA DE CV | Mexico | Maker | PF Keep / Cad Cam Peek Block | 2 | 2025 |
| Graphenano Dental, SL | Spain | Maker | G-CAM · GRAPHENANO DENTAL | 2 | 2025 |
| Sincera Technology (changchun) Co., Ltd | China | Maker | Light Cure Composite | 2 | 2024 |
| Smart Denture Conversions, LLC | United States | Maker | — | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | Brilliant · BRILLIANT Bulk Fill Flow · BRILLIANT Crios · BRILLIANT EverGlow · +16 | 45 | 2022 |
| J. Morita USA, Inc. | United States | Maker | FormCore DC Core Build-up Material | 42 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | Belixa Injectable, Belixa Bulk Fill · Ti-Core · Ti-Core Natural | 15 | 2023 |
| New Stetic, SA | Colombia | Maker | Zafira | 5 | 2026 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Constic A1 · Constic A2 · Constic A3 · Constic A3,5 · +37 | 4 | 2022 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| KaVo Dental GmbH | Germany | Maker | 0.411.9650 - KaVo Spray AMERICA 2113 · 0.411.9660 - KaVo Spray AMERICA 2113 (Set) · 105.3844 - QUATTROcare plus Spray AMERICA 2141 · 105.4524 - QUATTROcare plus Spray AMERICA 2141 (Set) · +3 | 2 | 2021 |
| DSI Dental Solutions Ltd | Israel | Maker | Sil-Flow · Unilite Flow · Unilite Flow Kit · Unilite Universal Composite | 2 | 2025 |
| edelweiss dentistry products gmbh | Austria | Maker | Ceramir CAD/CAM C-BLOCK A0 · Ceramir CAD/CAM C-BLOCK A1 · Ceramir CAD/CAM C-BLOCK A2 · Ceramir CAD/CAM C-BLOCK A3 · +31 | 1 | 2024 |
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Brazil | Maker | SMART PRINT BIO VITALITY A2 · SMART PRINT BIO VITALITY A2-HT · SMART PRINT BIO VITALITY A3 · SMART PRINT BIO VITALITY A3-HT · +4 | 1 | 2026 |
| Stratasys Ltd | Israel | Maker | TrueDent Clear · TrueDent Cyan · TrueDent Magenta · TrueDent White · +1 | 1 | 2022 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | Denture Base Resin(PN-Denture (Red,White)) | 1 | 2024 |
| Creamed GmbH & Co. Produktions- und Handels KG | Germany | Maker | AMBARINO · ENA CAD · ENACAD | 1 | 2022 |
| Id Korea Co., Ltd. | South Korea | Maker | ID Light Cure System | 1 | 2025 |
| Sino-Dentex Co., Ltd. | China | Maker | Apoller | 1 | 2023 |
| Pulpdent Corporation | United States | Maker | ACTIVA PRESTO · ACTIVA SOLO FLOWABLE · DenTASTIC DUO · Dentin Conditioning Gel · +17 | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | Composite Restorative Paste/Paste Type · CuRAY Primet Metal Primer · CuRay-Dual Support · CuRay-Fil · +9 | 73 | 2020 |
| Reliance Orthodontic Products, Inc. | United States | Maker | Flowtain · Flowtain LV · OrthoFlow · TKO Clear · +1 | 32 | 2021 |
| Cavex Holland BV | Netherlands | Maker | Quadrant Anterior Shine · Quadrant Core LC · Quadrant Flow · Quadrant Posterior Dense · +3 | 26 | 2015 |
| Sterngold | United States | Maker | Omegaflo · SternOmega | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Tokuyama Dental Corporation | Japan | Maker | E-1 Esthetic Composite System · Estelite Bulk Fill Flow · Estelite Color · Estelite Omega · +8 | 19 | 2021 |
| Bicon, LLC | United States | Maker | TRINIA | 18 | 2015 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | Interlig | 11 | 2021 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Core · Prime-Dent Automix Dual Cure Core Build Up Material · Prime-Dent Chemical Core Build Up Material · Prime-Dent Chemical Cure Composite Restorative Material · +27 | 9 | 2012 |
| Merz Dental GmbH | Germany | Maker | PEEK Biosolution | 8 | 2017 |
| ITENA Clinical | France | Maker | Material, tooth shade, resin | 8 | 2017 |
| Micerium S.P.A. | Italy | Maker | ENA CEM HV · ENA FLOW · ENA HFO · ENA HRi · +4 | 6 | 2011 |
| Nanova Biomaterials Inc | United States | Maker | — | 5 | 2018 |
| Nobio Ltd. | Israel | Maker | Infinix Bulk Fill Flow Composite · Infinix Flowable Composite · Infinix Universal Composite | 5 | 2020 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Final Crown · Permanent Crown · SprintRay Crown · VarseoSmile Crown plus · +1 | 4 | 2013 |
| Silmet , Ltd. | Israel | Maker | Hybrid Flowable · ProFil · ProFil Bulk · ProFil Core · +11 | 3 | 2011 |
| Advanced Healthcare , Ltd. | United Kingdom | Maker | Glass Ionomer Aesthetic Restorative · Universal L/C Composite (Beautifil) | 3 | 2003 |
| Bioloren S.R.L. | Italy | Maker | FIBER DISK AND BLOCK PERMANENT, · TRILOR | 3 | 2018 |
| MK-dent GmbH | Germany | Maker | place holder | 2 | 2005 |
| Cendres+Metaux SA | Switzerland | Maker | 01060003 Pekkton® ivory press blanks / 10 p. · 01060011 Pekkton® ivory milling blank ø 98.5/16mm (with steps) · 01060014 Pekkton® ivory milling blank ø 98.5/t12mm (with steps) · 01060020 Pekkton® ivory milling blank ø 98.5/20mm (with steps) · +9 | 2 | 2020 |
| Dental Technologies, Inc. | United States | Maker | Alpha II AP · Alpha-Core DC · Alpha-Dent Light Activated Core Build Up Blue · Alpha-Dent Light Cure Composite · +4 | 2 | 2013 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | Tru-Paque | 2 | 1986 |
| Temrex Corp. | United States | Maker | GEL-ETCH · GENTLE-ETCH · INTERVAL LC | 2 | 2012 |
| Dentkist, Inc. | South Korea | Maker | CharmFil Flow · CharmFil Plus · CharmFil Plus Caps · Flow Resin ALOOZ | 2 | 2020 |
| Denali R & D Corporation | United States | Maker | AURA Core · Aura Protective Sealer · AURA Vue · Clear Vue · +1 | 2 | 2009 |
| anax dent GmbH | Germany | Maker | anaxBLEND · anaxGUM · anaxPINK | 2 | 2012 |
| ADM, a.s. | Czechia | Maker | DENTAPREG · Dentapreg BRAID · Dentapreg BUNDLE · Dentapreg INTRO · +13 | 1 | 1995 |
| B.J.M. Laboratories Ltd | Israel | Maker | Block-Out Resin · CompCore AF, Intro and Refill shades · HIGH-Q-BOND · HIQ-Q-BOND SE · +12 | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA LC Glass Ionomer Restorative · IDENTA LC Nano Hybrid Composite · IDENTA LC Nano Hybrid Flowable Composite · IDENTA LC Posterior Fill · +2 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| IDOC Dental Lab | United States | Maker | Rodin 3D Ceramic Nanohybrid Resin; Rodin Sculpture 2; Rodin Titan | — | — |
| medmix Deutschland GmbH | Germany | Maker | CRYSTALLINE C2 AND CRYSTALLINE L3 · iBond Universal & iBond Ceramic Primer | — | — |
| Oxford Performance Materials, Inc. | United States | Maker | Pekkton® Ivory Milling blank 95/t12mm · Pekkton® Ivory Milling blank 95/t16mm · Pekkton® Ivory Milling blank 95/t20mm · Pekkton® Ivory Milling blank 95/t25mm · +6 | — | — |
| Conamco | United States | Maker | Crushed Quartz · Medental | — | — |
| 3BFAB Teknoloji Anonim Sirketi | Türkiye | Maker | Dentafab NanoCeram | — | — |
| SMD Dental Laboratory | South Korea | Maker | MAZIC Duro | — | — |
| UFP Technologies, Inc. | United States | Maker | Tooth Shade Resin Material | — | — |
| indigodental GmbH | Germany | Maker | — | — | — |
| Dental Laboratory Milling Supplies LLC, DBA Digital Dental, | United States | Maker | — | — | — |
| MANI Medical Germany GmbH | Germany | Maker | — | — | — |
| Shandong Huge Dental Material Corporation | China | Foreign exporter | TopCEM Dual Cure Resin Cement · UltraCore Dual Cure Resin Cement | 8 | 2026 |
| American Orthodontics | United States | Contract manufacturer | Acid Etching (Gel, Semi-Gel, Liquid) | 44 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Flowable Composite · Universal Composite | 23 | 2025 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Brush and Sculpt · BulkFill · Complete Dual-Cure Catalyst · CosmeCore · +11 | 27 | 2024 |
| Vertex-Dental B.V. | Netherlands | Foreign exporter | Saremco Print Crowntec | 7 | 2024 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| Dent Zar, Inc. | United States | Repacker / relabeler | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE · Chemical Cured Bonding Agent · ENAMEL CONDITIONER (ENAMEL ETCHING AGENT) · FANTASTIC CONTACT CURE ORTHODONTIC ADHESIVE FOR PLASTIC AND METAL BRACKETS · +3 | 12 | 1996 |
| Medental Intl. | United States | Repacker / relabeler | Medental | 7 | 1999 |
| Directa AB | Sweden | Contract manufacturer | Ceramir CAD/CAM block | 1 | 2015 |
| Dharma Research, Inc. | United States | Contract manufacturer | ADS Hema Desensitizer · Lapiss Hema Desensitizer · Sherbet Hema Desensitizer | 1 | 2015 |
| Rmo, Inc. | United States | Manufacturer | Adhesive Orthodontic Bracket and Tooth Conditioner Resin - TruLock | 1 | 1990 |
| World Class Technology Corporation | United States | Manufacturer | Aspire | 1 | 2019 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | gel etch · Ultra Band Lok | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | Admira Fusion X-Base · BEAUTIFIL FLOW PLUS · BEAUTIFIL II · CERASMART · +32 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Coating · Core · Dental cement · Dental Filling · +10 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Adhesive, Resin, Composite · dental composite, resin, cement · Flowable Composite Restorative · Universal Composite Restorative · +1 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Aura; Aura Bulk Fill; Aura eASY · G-aenial Injection Matrix Kit; G-aenial Universal Flo; MI Fil · Gradia Direct Flo · Material, tooth shade, resin · +6 | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Chemical Cure Composite Restorative Material · Chemical Cure Composite Restorative Material; Chemical Cure Dentin/Enamel Bonding Adhesive · Chemical Cure Dentin/Enamel Bonding Adhesive · Citric Acid · +34 | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | core · Dental · Dental Cement · dental composite · +10 | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Beautifil Flow · Charisma Composites · EsthetX HD · Filtek Z350XT Composite · +9 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | Blue Etch · Topical Gel | — | — |
| Premium Plus Dental | United States | Lister | Stela Automix System | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIAETCH · DIAFIL · DIAFIL Bulk FLOW · DIAFIL Capsule · +3 | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | — | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | Esthet · Material, Tooth shade, Resin · Surefil | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN · MATERIAL, TOOTH SHADE, RESIN | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Resin Tooth Shade Material · Tooth Shade Resin Material | — | — |
| Viarden Lab LLC | United States | Manufacturer for export | DESENSITIZER VIARDEN LAB, C-PROTECTOR, VIARCLEAN UP V · FEELING LUX NANO HYBRID, FEELING LUX ZR, FEELING LUX ADHESIVE, FEELING LUX SEALNT, ETCHING GEL, PROETCH, STAINS | — | — |
| Bina Limited | Belize | Foreign exporter | Material, tooth shade, resin · SEALANT | — | — |
| Dental Brands for Less | Canada | Foreign exporter | 3M-ESPE | — | — |
| anaxdent North America | United States | Lister | anaxBLEND · anaxGUM · anaxPINK · Mock-up Direct · +1 | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | PERFORMA ADHEVISE | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent · Master-Dent Anterior/Posterior Composite Restorative · Master-Dent Core Build-Up Material · Material, Tooth Shade, Resin | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | Hyramic CAD/CAM Restorative | — | — |
| NU Radiance, Inc. | United States | Repacker / relabeler | FloComp-It · Nu Radiance Etching Gel · Nu Radiance Liquid Enamel Conditioner · PostComp-It · +6 | — | — |
| Axiodent Inc. | United States | Repacker / relabeler | — | — | — |
| Signa Medical, Inc. | United States | Repacker / relabeler | DenMat Bulk Fill; Evanesce Bulk Fill · DenMat Tenure; Tenure MPB · MATERIAL, TOOTH SHADE, RESIN | — | — |
| Sanicure BV | Netherlands | Foreign exporter | EBG - CROWN AND BRIDGE, TEMPORARY, RESIN EBF - Material, tooth shade, resin · Material, tooth shade, resin | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | Hyramic CAD/CAM Restorative | — | — |
| Zapalign LLC | United States | Repacker / relabeler | EBF - Material, tooth shade, resin KLE - AGENT, TOOTH BONDING, RESIN | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | Core Build Up | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | Material, tooth shade, resin | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | G-CAM | — | — |
| Primotec LLC | United States | Repacker / relabeler | PrimoPink | — | — |
| Prais Reliable Dental Supplies S.A | Seychelles | Foreign exporter | Beautifil Flow Plus · Herculite Enamel · Herculite Syringe · Herculite Unidose | — | — |
| Upcera Dental America Inc. | United States | Repacker / relabeler | Hyramic CAD/CAM Restorative | — | — |
| HEXA Dental | United States | Contract manufacturer | Hexa Bonding · Hexa Composite | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | BEAUTIFIL II · BEAUTIFIL II LS | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| MN Health Inc, | United States | Repacker / relabeler | — | — | — |
| SR China | China | Repacker / relabeler | GRADIA PREMi | — | — |
| The Atlanta Dental supply Company | United States | Repacker / relabeler | Admira Flow | — | — |
| Dylan Lucas International Inc | Canada | Foreign exporter | — | — | — |
| EdelweissDR AG | Switzerland | Repacker / relabeler | — | — | — |
| Frontier Dental Supply Inc | Canada | Foreign exporter | — | — | — |
| Imperial Trading Limited | Barbados | Foreign exporter | — | — | — |
| Innopex Limited | 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 | — | — | — |
| Pharmco Medical B.V. | Netherlands | Foreign exporter | — | — | — |
| Tas Medical Supply | United States | Foreign exporter | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | 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 composites 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 Shade MaterialEBF | 2 | 872.3690 | 108 | 937 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Sep 2026 | K262982 | Core·it Dual | Spident Co., Ltd. | EBF Resin Tooth Shade Material |
| 10 Sep 2026 | K262202 | Cerasmart Forte | GC America Inc. | EBF Resin Tooth Shade Material |
| 31 Aug 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | EBF Resin Tooth Shade Material |
| 1 Jul 2026 | K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | EBF Resin Tooth Shade Material |
| 1 Jul 2026 | K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 18 Jun 2026 | K261246 | SRGC-06 | GC America Inc. | EBF Resin Tooth Shade Material |
| 2 Jun 2026 | K261093 | DIAFIL | DiaDent Group International | EBF Resin Tooth Shade Material |
| 19 May 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | EBF Resin Tooth Shade Material |
| 11 May 2026 | K260805 | Dual Core | Vericom Co., Ltd. | EBF Resin Tooth Shade Material |
| 27 Apr 2026 | K261357 | Grandio disc multicolor | Voco GmbH | EBF Resin Tooth Shade Material |
| 27 Apr 2026 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 23 Apr 2026 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | EBF Resin Tooth Shade Material |
| 15 Apr 2026 | K260661 | Midas Restore | SprintRay Inc. | EBF Resin Tooth Shade Material |
| 6 Apr 2026 | K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 11 Mar 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | EBF Resin Tooth Shade Material |
| 3 Mar 2026 | K254245 | ZAFIRA® | New Stetic, SA | EBF Resin Tooth Shade Material |
| 21 Jan 2026 | K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 5 Dec 2025 | K252465 | Any-Core | Mediclus Co., Ltd | EBF Resin Tooth Shade Material |
| 7 Nov 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | EBF Resin Tooth Shade Material |
| 29 Sep 2025 | K253236 | G-BLOCK | Graphenano Dental, SL | EBF Resin Tooth Shade Material |
| 23 Sep 2025 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 29 Aug 2025 | K251946 | G aenial Universal Injectable II | GC America Inc. | EBF Resin Tooth Shade Material |
| 6 Jun 2025 | K251283 | Once-Fil Flow | Mediclus Co., Ltd | EBF Resin Tooth Shade Material |
| 30 May 2025 | K250317 | EsFlow PLUS | Spident Co., Ltd. | EBF Resin Tooth Shade Material |
| 27 May 2025 | K251578 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 23 May 2025 | K250778 | Sil-Flow | DSI Dental Solutions Ltd | EBF Resin Tooth Shade Material |
| 21 May 2025 | K251239 | GrandioSO Unlimited | Voco GmbH | EBF Resin Tooth Shade Material |
| 12 May 2025 | K250763 | Reon | C.E.I.B.Med | EBF Resin Tooth Shade Material |
| 30 Apr 2025 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 14 Apr 2025 | K250823 | Any-Com Flow | Mediclus Co., Ltd | EBF Resin Tooth Shade Material |
| 14 Mar 2025 | K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) | Kettenbach GmbH & Co. KG | EBF Resin Tooth Shade Material |
| 7 Feb 2025 | K242713 | Any-Com Bulk | Mediclus Co., Ltd | EBF Resin Tooth Shade Material |
| 20 Dec 2024 | K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao HuGe Biomaterials Company, Ltd. | EBF Resin Tooth Shade Material |
| 18 Dec 2024 | K243720 | 3Delta UNlimited | Deltamed GmbH | EBF Resin Tooth Shade Material |
| 17 Dec 2024 | K242816 | Quantium | Bisco, Inc. | EBF Resin Tooth Shade Material |
| 27 Nov 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | EBF Resin Tooth Shade Material |
| 18 Oct 2024 | K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | edelweiss dentistry products gmbh | EBF Resin Tooth Shade Material |
| 18 Oct 2024 | K232994 | Vittra APS Unique Flow | Dentscare Ltda | EBF Resin Tooth Shade Material |
| 15 Oct 2024 | K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | EBF Resin Tooth Shade Material |
| 15 Oct 2024 | K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd | EBF Resin Tooth Shade Material |