Prosthetic devices · 21 CFR 872 Subpart D
Resin Tooth Shade Material
FDA device type “Material, Tooth Shade, Resin”.
- Companies listing it
- 175108 makers
- Brands and models
- 1,181
- 510(k) clearances
- 93778 in five years
- FDA name
- Material, Tooth Shade, Resin
510(k) clearances per year, 1976–2026
Companies that list EBF
175 companies currently list this device type with FDA.
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 21 Sep 2026 | K262982 | Core·it Dual | Spident Co., Ltd. |
| 10 Sep 2026 | K262202 | Cerasmart Forte | GC America Inc. |
| 31 Aug 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. |
| 1 Jul 2026 | K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. |
| 1 Jul 2026 | K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, AG |
| 18 Jun 2026 | K261246 | SRGC-06 | GC America Inc. |
| 2 Jun 2026 | K261093 | DIAFIL | DiaDent Group International |
| 19 May 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International |
| 11 May 2026 | K260805 | Dual Core | Vericom Co., Ltd. |
| 27 Apr 2026 | K261357 | Grandio disc multicolor | Voco GmbH |
| 27 Apr 2026 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 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. |
| 15 Apr 2026 | K260661 | Midas Restore | SprintRay Inc. |
| 6 Apr 2026 | K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd |
| 11 Mar 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC |
| 3 Mar 2026 | K254245 | ZAFIRA® | New Stetic, SA |
| 21 Jan 2026 | K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 5 Dec 2025 | K252465 | Any-Core | Mediclus Co., Ltd |
| 7 Nov 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company |
| 29 Sep 2025 | K253236 | G-BLOCK | Graphenano Dental, SL |
| 23 Sep 2025 | K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 29 Aug 2025 | K251946 | G aenial Universal Injectable II | GC America Inc. |
| 6 Jun 2025 | K251283 | Once-Fil Flow | Mediclus Co., Ltd |
| 30 May 2025 | K250317 | EsFlow PLUS | Spident Co., Ltd. |
| 27 May 2025 | K251578 | BEAUTIFIL II | Shofu Inc |
| 23 May 2025 | K250778 | Sil-Flow | DSI Dental Solutions Ltd |
| 21 May 2025 | K251239 | GrandioSO Unlimited | Voco GmbH |
| 12 May 2025 | K250763 | Reon | C.E.I.B.Med |
| 30 Apr 2025 | K250497 | Additive Manufacturing (Light Curing) Crown Bridge Resin | Aidite (Qinhuangdao) Technology Co., Ltd |
| 14 Apr 2025 | K250823 | Any-Com Flow | Mediclus Co., Ltd |
| 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 |
| 7 Feb 2025 | K242713 | Any-Com Bulk | Mediclus Co., Ltd |
| 20 Dec 2024 | K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao HuGe Biomaterials Company, Ltd. |
| 18 Dec 2024 | K243720 | 3Delta UNlimited | Deltamed GmbH |
| 17 Dec 2024 | K242816 | Quantium | Bisco, Inc. |
| 27 Nov 2024 | K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited |
| 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 |
| 18 Oct 2024 | K232994 | Vittra APS Unique Flow | Dentscare Ltda |
| 15 Oct 2024 | K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC |
| 15 Oct 2024 | K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd |
| 8 Oct 2024 | K242014 | Jet Flow Bulk | Meta Biomed Co, Ltd |
| 1 Oct 2024 | K242277 | Crown HT | SprintRay Inc. |
| 26 Sep 2024 | K241147 | Any-Com | Mediclus Co., Ltd |
| 17 Sep 2024 | K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Kulzer, LLC |
| 11 Sep 2024 | K232559 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd |
| 27 Jun 2024 | K240823 | els extra low shrinkage® composite & els extra low shrinkage® flow | Saremco Dental AG |
| 25 Apr 2024 | K231142 | Temporis, Irix Plus | Dws S.R.L. |
| 15 Mar 2024 | K240694 | FORMA Composite (Shade A3D) | Ultradent Products, Inc. |
| 15 Mar 2024 | K240112 | Light Cure Composite | Sincera Technology (changchun) Co., Ltd |
| 5 Jan 2024 | K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited |
| 22 Dec 2023 | K233082 | TopCEM Dual Cure Resin Cement | Rizhao HuGe Biomaterials Company, Ltd. |
| 14 Nov 2023 | K232050 | saremco print BRIDGETEC | Saremco Dental AG |
| 9 Nov 2023 | K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG |
| 1 Nov 2023 | K233502 | TERA HARZ II | Graphy, Inc. |
| 7 Sep 2023 | K230644 | Signum opaque F | Kulzer, LLC |
| 24 Jul 2023 | K231523 | EsCom250 | Spident Co., Ltd. |
| 13 Jul 2023 | K230877 | Admira Fusion 5 | Voco GmbH |
| 8 Mar 2023 | K223742 | Dental Ceramic Blocks | Aidite (Qinhuangdao) Technology Co., Ltd |
| 6 Mar 2023 | K222445 | LC ChromeFlow | S&C Polymer Silicon- Und Composite Spezialitaten GmbH |
| 14 Dec 2022 | K222623 | Digital Crown | SprintRay Inc. |
| 6 Dec 2022 | K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | Premier Dental Products Company |
| 28 Oct 2022 | K222583 | Stela Capsule System | Sdi Limited |
| 28 Oct 2022 | K222581 | Stela Automix System | Sdi Limited |
| 12 Oct 2022 | K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. |
| 11 Oct 2022 | K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Cosmedent, Inc. |
| 23 Sep 2022 | K222877 | FREEPRINT crown | Detax GmbH |
| 23 Sep 2022 | K213339 | DENU Composite Resin, DENU Flow Resin | HDI Inc. |
| 9 Sep 2022 | K222723 | AMBARINO High-Class | Creamed GmbH & Co. Produktions- und Handels KG |
| 31 Aug 2022 | K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Sybron Dental Specialties |
| 16 Aug 2022 | K220329 | G-CAM | Graphenano Dental, SL |
| 9 Aug 2022 | K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS |
| 1 Jul 2022 | K221909 | J-Temp | Ultradent Products, Inc. |
| 13 Jun 2022 | K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products |
| 25 May 2022 | K202920 | OptiComp | Pac-Dent Inc. |
| 21 Apr 2022 | K220605 | Venus Bulk Flow ONE | Kulzer, LLC |
| 21 Jan 2022 | K213343 | Saremco Print CROWNTEC | Saremco Dental AG |
| 6 Dec 2021 | K211804 | 3Delta Crown | Deltamed GmbH |
| 24 Nov 2021 | K211345 | C-30 Crown Kit | Perfect Fit Crowns, LLC |
| 14 Oct 2021 | K210231 | Vittra APS Unique | Dentscare Ltda |
| 6 Oct 2021 | K202063 | TrusFIL Universal Composite Restorative | Rizhao HuGe Biomaterials Company, Ltd. |
| 22 Sep 2021 | K210045 | ACTIVA PRESTO PACK | Pulpdent Corporation |
| 26 Jul 2021 | K210412 | Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent Inc. |
| 20 Jul 2021 | K210349 | TKO Composite Bite Turbo Gel | Reliance Orthodontic Products, Inc. |
| 15 Jul 2021 | K202846 | TERA HARZ | Graphy, Inc. |
| 28 Jun 2021 | K210421 | Diafil & Diafil Capsule | DiaDent Group International |
| 24 Jun 2021 | K211259 | Renamel Bulkfill | Cosmedent, Inc. |
| 25 May 2021 | K210977 | E-Dent 1000 | Envisiontec GmbH |
| 5 Feb 2021 | K200470 | Shofu Block HC Hard | Shofu Inc |
| 3 Feb 2021 | K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation |
| 22 Dec 2020 | K201707 | Opallis, Opallis Flow | Dentscare Ltda |
| 30 Nov 2020 | K200155 | Bright High Flow | GENOSS Co., Ltd. |
| 27 Oct 2020 | K200156 | Bright Low Flow | GENOSS Co., Ltd. |
| 28 Sep 2020 | K201795 | Transcend | Ultradent Product, Inc. |
| 19 Aug 2020 | K193537 | Omnichroma Flow | Tokuyama Dental Corporation |
| 14 Aug 2020 | K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Nobio Ltd. |
| 8 Jul 2020 | K201307 | VisCalor | Voco GmbH |
| 23 Jun 2020 | K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG |
| 6 May 2020 | K193496 | CharmFil | Dentkist, Inc. |
| 24 Apr 2020 | K190139 | Zircos-Com | Bioden Co., Ltd. |
| 27 Mar 2020 | K200294 | GrandioSO Light Flow | Voco GmbH |
| 25 Mar 2020 | K192284 | DiaFil Flow | DiaDent Group International |
| 20 Mar 2020 | K192510 | DIAFIL & DIAFIL Capsule | DiaDent Group International |
| 5 Mar 2020 | K191991 | Ezfil | Meta Biomed Co, Ltd |
| 25 Feb 2020 | K191389 | Allcem Veneer APS | Dentscare Ltda |
| 20 Dec 2019 | K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS |
| 16 Dec 2019 | K191306 | Llis, Vittra APS | Dentscare Ltda |
| 22 Nov 2019 | K192260 | everX Flow | GC America Inc. |
| 18 Nov 2019 | K191980 | CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. |
| 29 Oct 2019 | K191385 | BRILLIANT COMPONEER | Coltene/Whaledent AG |
| 13 Sep 2019 | K182921 | Infinix Universal Composite | Nobio Ltd. |
| 4 Sep 2019 | K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda |
| 12 Jul 2019 | K182714 | Novidia Bulk Fill Flow Composite | Nobio Ltd. |
| 3 Jul 2019 | K182780 | XP Composite | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH |
| 3 Jul 2019 | K182580 | Novidia Flowable Composite | Nobio Ltd. |
| 21 Jun 2019 | K190597 | BRILLIANT EverGlow Flow | Coltene/Whaledent AG |
| 3 May 2019 | K182430 | CLEARFIL MAJESTY IC | Kuraray Noritake Dental, Inc. |
| 22 Apr 2019 | K182778 | LC GLOSSFILL XR | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH |
| 11 Apr 2019 | K190453 | VisCalor bulk | Voco GmbH |
| 14 Mar 2019 | K183380 | Tetric PowerFill | Ivoclar Vivadent, AG |
| 9 Jan 2019 | K182869 | Fit SA | Shofu Inc |
| 2 Jan 2019 | K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products |
| 14 Dec 2018 | K182296 | HyperFil-LV | Parkell, Inc |
| 20 Nov 2018 | K182288 | TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona, Inc. |
| 15 Nov 2018 | K181689 | Nexcomp | Meta Biomed Co, Ltd |
| 14 Nov 2018 | K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC |
| 22 Aug 2018 | K181312 | GrandioSO x-tra | Voco GmbH |
| 15 Aug 2018 | K181500 | BRILLIANT Crios | Coltene/Whaledent AG |
| 12 Jul 2018 | K180613 | Estelite Universal Flow | Tokuyama Dental Corporation |
| 3 Jul 2018 | K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. |
| 18 Jun 2018 | K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Zirkonzahn Srl |
| 11 Jun 2018 | K180649 | BeautiCem Veneer Kit | Shofu Inc |
| 7 Jun 2018 | K173573 | Tetric CAD | Ivoclar Vivadent, AG |
| 8 Mar 2018 | K173500 | NMF004A | GC America Inc. |
| 27 Feb 2018 | K173275 | OMNICHROMA | Tokuyama Dental Corporation |
| 24 Feb 2018 | K173643 | Trilor Disks, Blocks and Arches | Bioloren S.R.L. |
| 31 Jan 2018 | K171772 | Ecosite Bulk Fill | Dmg USA, Inc. |
| 18 Dec 2017 | K173124 | PEEK Biosolution | Merz Dental GmbH |
| 6 Dec 2017 | K172530 | BEAUTIFIL Flow Plus X | Shofu Inc |
| 5 Dec 2017 | K172707 | Renamel Microfill | Cosmedent, Inc. |
| 15 Nov 2017 | K171815 | Registrado Scan | Voco GmbH |
| 13 Nov 2017 | K170102 | Pekkton Ivory | Cendres+Metaux SA |
| 2 Oct 2017 | K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl | Swissmeditec GmbH |
| 10 Aug 2017 | K171200 | Grandio blocs | Voco GmbH |
| 4 Aug 2017 | K171147 | REVEAL Bulk | Bisco, Inc. |
| 29 Jun 2017 | K170896 | Admira Fusion x-base | Voco GmbH |
| 3 Apr 2017 | K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation |
| 24 Mar 2017 | K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC |
| 17 Mar 2017 | K163346 | MAZIC Duro | Vericom Co., Ltd. |
| 24 Feb 2017 | K163480 | Renamel NANO +plus | Cosmedent, Inc. |
| 12 Jan 2017 | K162323 | Tooth Shade Resin Material | Liaoning Upcera Co., Ltd |
| 11 Jan 2017 | K162261 | CERAMAGE UP | Shofu Inc |
| 28 Nov 2016 | K163207 | Filtek One Bulk Fill Restorative | 3M Company |
| 16 Nov 2016 | K162537 | CAD/CAMouflage Milling Block | Prismatik Dentalcraft, Inc. |
| 15 Nov 2016 | K160049 | Charisma | Heraeus Kulzer, LLC (Mitsui Chemicals Group) |
| 7 Nov 2016 | K162257 | P1145 Dental Restorative | Sybron Dental Specialties |
| 24 Oct 2016 | K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow | Schutz Dental GmbH |
| 27 Sep 2016 | K162107 | TPH Spectra+ Universal Composite Restorative | Dentsply Sirona, Inc. |
| 23 Aug 2016 | K153476 | KATANA AVENCIA Block | Kuraray Noritake Dental, Inc. |
| 4 Aug 2016 | K152471 | CAPO BULK FILL | Schutz Dental GmbH |
| 29 Jul 2016 | K153493 | Clip Flow | Voco GmbH |
| 27 Jul 2016 | K160596 | BEAUTIFIL II LS | Shofu Inc |
| 21 Jul 2016 | K160086 | SHOFU Enamel Conditioner | Shofu Inc |
| 21 Jul 2016 | K152113 | BioHPP - breCAM.BioHPP | bredent GmbH & Co. KG |
| 15 Jul 2016 | K160425 | CAD/CAMouflage Milling Bock | Prismatik Dentalcraft, Inc. |
| 12 Jul 2016 | K153325 | Gradia Plus | GC America Inc. |
| 30 Jun 2016 | K153177 | Admira Fusion Flow | Voco GmbH |
| 20 May 2016 | K153127 | everX Posterior | GC America Inc. |
| 28 Apr 2016 | K152927 | BRILLIANT EVERGLOW | Coltene/Whaledent AG |
| 1 Apr 2016 | K153249 | Pulpdent Solo Flowable Composite with MCP | Pulpdent Corporation |
| 2 Mar 2016 | K151700 | BEAUTIFIL II Gingiva | Shofu Inc |
| 26 Feb 2016 | K153191 | Calcium Bridge | Denali Corporation |
| 30 Dec 2015 | K152373 | VITA VM LC Flow | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. |
| 10 Dec 2015 | K151699 | BEAUTIFIL II Enamel | Shofu Inc |
| 17 Nov 2015 | K152004 | Nanova Universal Composite | Nanova Biomaterials Inc |
| 20 Oct 2015 | K151956 | Admira Fusion x-tra | Voco GmbH |
| 9 Oct 2015 | K151541 | G-Fix | GC America Inc. |
| 21 Sep 2015 | K151514 | Prestige | Danville Materials, LLC |
| 28 Aug 2015 | K151088 | DMRC Bulk Fill | Danville Materials, LLC |
| 21 Jul 2015 | K151094 | Mosaic Universal Composite | Ultradent Products, Inc. |
| 2 Jul 2015 | K150784 | Admira Fusion | Voco GmbH |
| 23 Jun 2015 | K150218 | Fill-Up! | Coltene/Whaledent AG |
| 18 Jun 2015 | K150623 | Nanova Flowable Composite | Nanova Biomaterials Inc |
| 9 Jun 2015 | K150393 | TETRIC EVOFLOW BULK FILL | Ivoclar Vivadent, AG |
| 2 Jun 2015 | K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC |
| 15 May 2015 | K143694 | Rhondium One-Visit-Crown(OVC) | Rhondium, Ltd. |
| 1 May 2015 | K143679 | Nuance FLOW | Den-Mat Holdings, LLC |
| 25 Mar 2015 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X | Kettenbach GmbH & Co. KG |
| 5 Feb 2015 | K143209 | SonicFill 2 | Sybron Dental Specialties |
| 25 Nov 2014 | K142389 | Variolink Esthetic | Ivoclar Vivadent, AG |
| 14 Nov 2014 | K141994 | BULK FILL FLOWABLE COMPOSITE | Novocol, Inc. |
| 10 Jul 2014 | K140976 | ENADEN FLOW | Km Corporation |
| 2 Jul 2014 | K140512 | UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE | Juno Dentistry LP |
| 25 Jun 2014 | K132115 | ABSOLUTE DENTIN 2 | Parkell, Inc |
| 4 Jun 2014 | K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) | Prismatik Dentalcraft, Inc. |
| 8 May 2014 | K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE | 3M Espe Dental Products |
| 9 Apr 2014 | K133182 | HTFX-222 | GC America Inc. |
| 14 Mar 2014 | K133824 | CERASMART | GC America Inc. |
| 14 Mar 2014 | K133608 | TRINIA | Bicon, LLC |
| 4 Dec 2013 | K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK | Shofu Inc |
| 14 Nov 2013 | K131753 | MERIDIAN | Ab Ardent |
Showing the 200 most recent of 937.
Official records: FDA product classification for EBF · 21 CFR 872.3690.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026