Denture resins & teeth: manufacturers and brands
164 companies make or specify denture materials among the 225 that list one with FDA, under 917 brand and model names. FDA has issued 395 510(k) clearances in this category, 49 of them in the last five years.
510(k) clearances per year, 1976–2026
Denture material 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 | Digital denture early experience kit · Lucitone Digital Print · Lucitone Digital Print for Primeprint · Genios | 148 | 2026 |
| Prismatik Dentalcraft, Inc. | United States | Maker | BioTemps NOW Milling Block;Bridge Block;A1 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A2 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A3 (5-pack) · BioTemps NOW Milling Block;Bridge Block;A3.5 (5-pack) · +27 | 56 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additively Manufactured Denture Resin · Denture Base Resin · Freeprint denture · 3D Printing Material Denture Base · +1 | 16 | 2026 |
| Voco GmbH | Germany | Maker | CediTEC · CediTEC DB · GrandTEC · Quick Up · +6 | 117 | 2026 |
| Shofu Inc | Japan | Maker | VERACIA · VERACIA SA · DENTADISC | 96 | 2025 |
| SprintRay Inc. | United States | Maker | Apex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink) · Apex Flex - Light Pink · Apex Flex - Standard Pink · Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) · +11 | 8 | 2026 |
| GC America Inc. | United States | Maker | Coe Comfort · Coe Lubricant · Coe Soft · Coe Soft Print · +31 | 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 |
| Kulzer, LLC | United States | Maker | dima Denture Base · dima Print Denture Base 2 · dima Print Try-In · Palabond · +10 | 37 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | CB11-A1 · CB11-A2 · CB11-A3 · CB11-A3.5 · +7 | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | BlueLine · Bonartic II NFC Plus · BonSelect TCR · Candulor Bonartic TCR · +54 | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | Ribbond · Ribbond-Triaxial | 7 | 2026 |
| Graphy, Inc. | South Korea | Maker | TERA HARZ DENTURE · Tera Harz Hard Denture | 6 | 2025 |
| Liaoning Upcera Co., Ltd | China | Maker | PMMA Blocks, FLNT Temp, FLNT Base | 10 | 2026 |
| Dental Direkt GmbH | Germany | Maker | DD base P HI · DD Bio Splint P HI | 9 | 2024 |
| Shandong Huge Dental Material Corporation | China | Maker | BioTemps NOW Milling Blocks · Denture Base · Denture Base Polymers · Flexible Block · +14 | 8 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | POP (Preformed Ovate Pontic) | 7 | 2025 |
| Deltamed GmbH | Germany | Maker | ACRIFIX Bonder · ACRIFIX rosa-opak · ACRIFIX rosa/pink · ACRIFIX rosa/pink Set · +11 | 6 | 2024 |
| LuxCreo Inc. | United States | Maker | FPD Reisn | 4 | 2026 |
| Saremco Dental AG | Switzerland | Maker | saremco print Crowntec | 4 | 2025 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Plan - Denture Module | 20 | 2024 |
| Kettenbach GmbH & Co. KG | Germany | Maker | MUCOPREN SOFT RELINING SYSTEM | 14 | 2026 |
| Harvest Dental Products, LLC | United States | Maker | EasyGum Composite Strip | 5 | 2023 |
| Imagine Milling Technologies, LLC | United States | Maker | Harvest Dental Polymer Blocks · NextDent Denture/E-Denture | 4 | 2026 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Denture UV · UltraPrint Flexible Denture UV · UltraPrint Denture Teeth UV | 3 | 2026 |
| Bisco, Inc. | United States | Maker | — | 88 | 2025 |
| Parkell, Inc | United States | Maker | Etch-free | 58 | 2025 |
| Somnomed, Inc. | United States | Maker | Flex · SomnoDent Air+ | 11 | 2026 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | Germany | Maker | VITA VIONIC BOND · VITA VIONIC® BASE RESIN IMPACT · VITA VIONIC VIGO · VITAPAN, VITAPAN PLUS, VITAPAN EXCELL, VITAPAN CUSPIFORM · +1 | 8 | 2026 |
| Vertex-Dental B.V. | Netherlands | Maker | Castapress · Castavaria · Ceramill Denture 3D+ · Hot Curing 20 Min Type C · +9 | 7 | 2024 |
| Dentca, Inc. | United States | Maker | DENTCA Base Hi-Impact · DENTCA Base Premium · DENTCA Denture Base II/DENTCA Try-In · DENTCA Denture Teeth | 6 | 2026 |
| Pac-Dent Inc. | United States | Maker | Rodin 3D Resin Denture Base | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMIDENT LUX · PAMA | 5 | 2022 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Basis · BASIS FLOW II · Basis Hi · Basis Twin Cure · +13 | 3 | 2026 |
| Keystone Industries | United States | Maker | Clearmet · Dentusil · Diamond D Denture Material · Duz-All · +14 | 2 | 2025 |
| Detax GmbH | Germany | Maker | Freepint denture impact dark reddish pink 1000g · freeprint denture flex pink 1000g · freeprint denture flex pink transparent 1000g · FREEPRINT® denture impact pink 1000 g · +29 | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | Rodin Titan 3d Resin · 23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle · 23986, Rodin Titan, Shade B1, 1.2kg/Bottle · 23987, Rodin Titan, Shade A1, 1.2kg/Bottle · +18 | 2 | 2026 |
| Formlabs Inc. | United States | Maker | Denture Base Resin V2 · Premium Teeth Resin | 2 | 2026 |
| Asiga | Australia | Maker | DentaBASE · DentaTOOTH | 2 | 2025 |
| Clemde SA DE CV | Mexico | Maker | PF Keep / Cad Cam Peek Block · Partial Flex | 2 | 2025 |
| Graphenano Dental, SL | Spain | Maker | G-CAM | 2 | 2025 |
| J. Morita USA, Inc. | United States | Maker | SilkLine Soft Denture Relining Material | 42 | 2022 |
| DIO Corporation | South Korea | Maker | DIOnavi-Denture · DIOnavi-Denture02 · DIOnavi-P. MAX · DIOnavi. C&B · +1 | 14 | 2023 |
| Dreve Dentamid GmbH | Germany | Maker | FotoDent denture | 6 | 2025 |
| New Stetic, SA | Colombia | Maker | Duracryl · EZ-Cryl · Fidelity · Novacryl · +25 | 5 | 2026 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | QuikGlaze · QuikGlaze XL · Silagum AM Comfort Primer Refi · Silagum AM Comfort Varnish Ref · +1 | 4 | 2022 |
| bredent GmbH & Co. KG | Germany | Maker | visio.lign color · visio.lign shield | 3 | 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 |
| Riton 3D Technology Co., Ltd | China | Maker | Denture Base Model D1-DP · Denture Base Model F1-TP · Denture Teeth Model DT1-A1 · Denture Teeth Model DT1-A2 · +1 | 1 | 2024 |
| Dental Manufacturing S.p.A. | Italy | Maker | ACRY PRINT 3D RU-004 DENTURE HI · ACRY PRINT 3D RU-005 GUIDE · ACRY NATURE AFG 6 LOWER · ACRY NATURE AFG 6 UPPER · +10 | 1 | 2026 |
| Stratasys Ltd | Israel | Maker | TrueDent Clear · TrueDent Cyan · TrueDent Magenta · TrueDent White · +1 | 1 | 2022 |
| Myerson LLC | United States | Maker | Dentivera · DuraFlex CAD disc · PermaSoft · Trusana · +6 | 1 | 2023 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | Denture Base Resin(PN-Denture (Red,White)) | 1 | 2024 |
| DENKEN-HIGHDENTAL Co., Ltd. | Japan | Maker | AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase · Rezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super Primer · Super Primer | 1 | 2022 |
| Huliang (shanghai) Bio-Tech Co., Ltd. | China | Maker | Perfect PMMA · PMMA BLOCK | 1 | 2023 |
| Id Korea Co., Ltd. | South Korea | Maker | ID Light Cure System | 1 | 2025 |
| Carbon, Inc. | United States | Maker | DB4000 High Impact Denture Base | 1 | 2026 |
| Cavex Holland BV | Netherlands | Maker | Cavex Instant Stone | 26 | 2015 |
| Sterngold | United States | Maker | Quickline/Instagums · Stern Vantage | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Tokuyama Dental Corporation | Japan | Maker | Sofreliner Tough · Sofreliner Tough S · TOKUYAMA REBASE III | 19 | 2021 |
| Bicon, LLC | United States | Maker | TRINIA | 18 | 2015 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | E-FIBER · Perma Fiber / Perma Mesh · PERMA MESH | 11 | 2021 |
| Lang Dental Mfg. Co., Inc. | United States | Maker | Acrylic Primer · FLEXACRYL HARD · FLEXACRYL SOFT · Jet Denture Repair · +8 | 9 | 2011 |
| Merz Dental GmbH | Germany | Maker | M-PM Disc (Pink) · PremEco Line Prothetic Color System · Promolux · Promolux HI · +12 | 8 | 2017 |
| Whip Mix Corporation | United States | Maker | VeriSplint IOS | 8 | 2016 |
| Schutz Dental GmbH | Germany | Maker | — | 7 | 2016 |
| Davis Schottlander & Davis, Ltd. | United Kingdom | Maker | — | 7 | 2004 |
| Micerium S.P.A. | Italy | Maker | TENDER FIBER DUE · TENDER FIBER ORTHO · TENDER FIBER QUATTRO | 6 | 2011 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | Emperor 5/20 · Emperor CC · Emperor Comf-Dent · Emperor Comfdent · +4 | 6 | 1986 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | VarseoSmile Teeth · VarseoSmile TriniQ | 4 | 2013 |
| St. George Technology, Inc. | United States | Maker | Excel Formula Heat Cure Denture Base Material · Excel Formula Heat-Cured Denture Base Material · Excel Formula Orthodontic Denture Base Material · Excel Formula Pourable Denture Base Material · +4 | 4 | 2003 |
| Major Prodotti Dentari S.P.A. | Italy | Maker | major.base 20 · major.repair · Bambino Tooth · Major AF Comp · +4 | 3 | 2008 |
| Bioloren S.R.L. | Italy | Maker | INFIBRA | 3 | 2018 |
| Thermoplastic Comfort Systems, Inc. | United States | Maker | iFlex by TCS · Karadent by TCS · Unbreakable by TCS | 3 | 2015 |
| Comfort Acrylics, Inc. | United States | Maker | Talon | 3 | 2019 |
| pro3dure medical GmbH | Germany | Maker | ACRY Print RU-004 Denture HI · ACRY Print RU-005 Guide · dima Print Denture Base 2 · dima Print Splint clear · +14 | 2 | 2021 |
| Manufacturera Dental Continental | Mexico | Maker | Bisacryl NicTone · Nic Tone Acrylic Resins · Nic Tone PolyCril · Nic Tone Selfcure Liquid | 2 | 2001 |
| George Taub Products & Fusion Co., Inc. | United States | Maker | STELLAR Attachment · STELLAR DC Acrylic · STELLAR LC Acrylic | 2 | 1986 |
| Polident d.o.o. | Slovenia | Maker | Artificial teeth CROSS LINKED 2 · Artificial teeth ICX-ROYAL · Artificial teeth REF-LINE · DD poly Y ML · +3 | 2 | 2016 |
| anax dent GmbH | Germany | Maker | Acryline | 2 | 2012 |
| Enlighten Materials Co., Ltd. | Taiwan | Maker | BB Base 3D printing resin for denture base | 2 | 2020 |
| Reliance Dental Mfg., LLC | United States | Maker | DuraConditioner, Dura Rely-A-Soft | 2 | 1987 |
| J.B.C and Co. | United States | Maker | CO.'S ORTHODONTIC ACRYLIC RESINS · JBC' | 2 | 2000 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | China | Maker | DENTURE PREFORMED (PARTIALLY PREFABRICATEDDENTURE | 1 | 2020 |
| Union Dental S.A. | Spain | Maker | ANAXDENT PMMA BLANK · CORiTEC PMMA DISC Monolayer & Multilayer · IDODENTINE BLOCK · IDODENTINE DISC · +12 | 1 | 2015 |
| The Myerson Company Limited | Trinidad & Tobago | Maker | Dentivera · DuraCetal · DuraFlex · PermaSoft · +8 | 1 | 2017 |
| National Dentex LLC | United States | Maker | SomnoDent MAS | 1 | 2012 |
| Wright Health Group | United Kingdom | Maker | Dentavit · Dentavit Monarch Acrotone Senator Dentorium · Dentoluux · Dentoluux V · +1 | 1 | 2013 |
| Valplast Intl. Corp. | United States | Maker | Valplast · Valplast 110N · Platinum Line | 1 | 2006 |
| Masterdent Ltda. | Colombia | Maker | DAVINCI · RAFAEL · RESISTAL · STARDENT · +2 | 1 | 2000 |
| Perflex Ltd | Israel | Maker | ACRYFREE BIOSENS FLEXINYLON · T-Crystal | 1 | 2015 |
| Blue Dent Dental | Brazil | Maker | Denture, plastic, teeth | 1 | 2018 |
| Talon Acrylics, Inc. | United States | Maker | Talon & Revere · Talon Thermoplastic Polymer/Revere Thermoplastic Polymer | 1 | 2007 |
| gebdi Dental Products GmbH | Germany | Maker | — | 1 | 2009 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental Plastic edge | — | — |
| Polydentia S.A. | Switzerland | Maker | F-Splint-Aid · F-Splint-Aid Slim · Fiber-Bond · Fiber-Plast · +8 | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | Biocryl ICE · Biocryl Resin · Biocryl X · Splint Biocryl Resin · +1 | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA Hard Relining (1:1) · IDENTA Soft Relining | — | — |
| Nanjing Chamlion Laser Technology Co., Ltd. | China | Maker | Malo Bridge · Synthetic Polymer Teeth(01) · Synthetic Polymer Teeth(02) · Synthetic Polymer Teeth(03) · +28 | — | — |
| IDOC Dental Lab | United States | Maker | Lucitone Digital Print | — | — |
| Shanghai Fanta Dental Materials Co., Ltd. | China | Maker | 3D Tooth | — | — |
| one day dental partner | South Korea | Maker | kage Denture preformed (partially prefabricated denture) · kage Denture, plastic, teeth,print · kage Additively manufactured, preformed, resin denture tooth-print | — | — |
| Aadi Med Private Limited | India | Maker | Re-Inforcement Mesh (Golden / Silver) | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Crown · PriZma 3D Bio Crown Diamond · PriZma 3D Bio Crown Tough | — | — |
| Shenzhen Sunmc Dental Technology Co., Ltd. | China | Maker | Denture, plastic, teeth | — | — |
| Suzhou laixin 3D Technology Co.,Ltd | China | Maker | Dental Teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) · Dental Teeth Plus (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) · Print teeth (A1,A2,A3,A3.5,B1,B2,B3,Bleach,C2) | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Teeth shade guide | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | arylic dentures | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Professional Shade Guide | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Evoden Industria Comercio Importacao e Exportacao de Produto | Brazil | Maker | Evoblock · Perleon · Duodent · Duolut · +4 | — | — |
| China Dental Outsourcing Inc | China | Maker | DENTURE PREFORMED (PARTIA · Valplast · DENTURE · TEETH | — | — |
| Dxin Trading HK Co., Limited | China | Maker | arylic dentures | — | — |
| Huile Denture Technology (Hong Kong) Co Limited | China | Maker | arylic dentures | — | — |
| Burbank Dental Lab | United States | Maker | — | — | — |
| Leixir Resources Private Limited | India | Maker | Lucitone Digital Print Denture System | — | — |
| Pan-Am Dental, Inc. | United States | Maker | RESIN, DENTURE, RELINING, REPAIRING, REBASING | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Maker | Denture, Plastic, Teeth | — | — |
| 3BFAB Teknoloji Anonim Sirketi | Türkiye | Maker | Dentafab NanoCeram | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Synthetic resin teeth | — | — |
| UFP Technologies, Inc. | United States | Maker | Tooth Shade Resin Material | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | FPD Reisn | — | — |
| Proto3000 Inc. | Canada | Maker | Vertex-Dental B.V. | — | — |
| Shenzhen Jiahong Dental Technology Co., Ltd | China | Maker | EKO · ELM | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Permanent Crown Resin · Denture Base Resin, Temporary C&B resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Permanent Crown Resin · Denture Base Resin, Temporary Dental Model Resin | — | — |
| Beijing Yingguan Dental Science&Technology Co.,Ltd. | China | Maker | CAD/CAM frame & partial denture PEEK · CAD/CAM full denture PEEK | — | — |
| Crown Trading (HK) Co., Limited | China | Maker | Denture, Plastic, Teeth | — | — |
| Foo Tian Dental Laboratory | China | Maker | Dental Removable Prosthesis like metal dentures&acrylic dentures&valplast denture | — | — |
| Smile Dental Laboratory Company Limited | China | Maker | Flexible,Partial and Full Denture | — | — |
| Sonrisa | United States | Maker | Easy Denture | — | — |
| VIVI Dental Laboratory | China | Maker | Denture, Plastic, Teeth | — | — |
| Bird-X, Inc. | United States | Maker | Coldpac Denture Acrylic | — | — |
| Caribbean Custom Mold Inc | Dominican Republic | Maker | Sonrisa | — | — |
| Istar dental lab | China | Maker | Acrylic denture: ACD-upper and lower; PRD-upper and lower | — | — |
| Kelsey Dental LLC | United States | Maker | medical titanium materials | — | — |
| Integrity Dental Services LLC | United States | Maker | Denture Preformed (Partially Prefabricated Denture) · Denture, Plastic, Teeth | — | — |
| Rite Smile Labs | China | Maker | premade acrylic teeth · 3d printed teeth artificial resin | — | — |
| Fricke Dental MFG. Co. | United States | Maker | HI-I, Vitacrilic, Vitalon, Pouresin, Profit, Polycast, Acupac, R&R | — | — |
| Huaxian Yuwei Dental Materials Factory | China | Maker | Yuwei Brand Synthetic Polymer Teeth (Ecostar,Suplar.Neputas,Physioca,Typlus) · Yuwei Brand Synthetic Polymer Teeth (Mercury, Venus, Mars, Jupiter, Saturn, Uranus, Neptune ) | — | — |
| MyoHealth Technologies, LLC | United States | Maker | Myoaligner Appliance | — | — |
| Nuvia MSO | United States | Maker | Nuvia Denture | — | — |
| Nuvia Smiles SAS | Colombia | Maker | Nuvia Smiles Dentures | — | — |
| Perfect crown dental lab | United States | Maker | Denture, plastic, teeth | — | — |
| Xi'an SinoTitanium Metals Co.,Ltd | China | Maker | medical titanium materials | — | — |
| AD Systems And Consulting (Pty) Ltd. | South Africa | Maker | Denture Base Resi n DT20 | — | — |
| Bio Composants Medicaux (BCM) | France | Maker | Fiber Force products (repackaged product of Fast Splint) | — | — |
| Co-Oral-Ite Dental MFG. Co. | United States | Maker | Teets | — | — |
| Enta B.V. | Netherlands | Maker | enta®cryl | — | — |
| Esstech, Inc | United States | Maker | FP3D | — | — |
| Mabel Dental Lab | United States | Maker | Now Denture | — | — |
| Makevale Ltd. | United Kingdom | Maker | Excel Formula Acrylics | — | — |
| Vita Tesco | China | Maker | MFT Teeth | — | — |
| Vynacron Dental Resins, Inc. | United States | Maker | VYNACRON | — | — |
| Zingo Digital Dental Lab LLC | United States | Maker | ZiNGO DIGITAL DENTAL LAB | — | — |
| CFS Dental Inc. | United States | Maker | — | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| Guangzhou Jinguanqiao Industry Co., Ltd | China | Maker | — | — | — |
| Shen FU Arts Lab | China | Maker | — | — | — |
| Zelia Dental Lab LLC | United States | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | Softline | 203 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | JuellCure Hard · JuellCure Hard Impression Material · JuellCure Soft · JuellCure Soft Impression Material | 8 | 2026 |
| CreoDent Prosthetics LTD | United States | Repacker / relabeler | Denture | 9 | 2022 |
| Hunan Vsmile Biotechnology Co.,Ltd | China | Contract manufacturer | Flexible Block | 2 | 2024 |
| The Argen Corporation | United States | Contract manufacturer | ArgenDS Denture Disc · ArgenPMMA EBG · ArgenPMMA EBI · ArgenPMMA MQC | 11 | 2024 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| ZimVie US Corp LLC | United States | Contract manufacturer | — | 1 | 2026 |
| Astron Dental Corporation | United States | Repacker / relabeler | Astron LC Light Cure Base Plate · Astron LC Light Cure Custom Tray · Astron LC Light Cure Reline | 5 | 1987 |
| Protech Professional Products, Inc. | United States | Manufacturer | ProTech Plus Self Cure Hard Reline and Repair Acrylic · ProTech UBAR Metal Bonding Acrylic | 2 | 2015 |
| Synca Marketing | Canada | Foreign exporter | Fast Splint Matrix 1:1 compressible hybrid bulk refill (40) · Fast Splint Matrix 1:4 compressible hybrid refill (40) · Fast Splint Matrix 1mm compressible bulk refill (40) · Fast Splint Matrix adhesive wax strips (8-55mm) · +28 | 1 | 2010 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental aligner removal hook · DENTURE BOX · ELASTIC PLACER · plastic retainer case · +1 | — | — |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | LCR · Triad Gel | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | COE COMFORT · COE SOFT · GC RELINE · KOOLINER II · +1 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Coe · Denture res · Kooliner · Perio · +2 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | Synthetic Polymer Teeth | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Hard Relining · Patterson Temporary Crown and Bridge Material | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Coe · denture · denture resin · Kooliner · +2 | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Coe Comfort · Coe Soft · Reline kit / Soft | — | — |
| Premium Plus Dental | United States | Lister | Denture, plastic teeth | — | — |
| Dentatus AB | Sweden | Manufacturer | TufLink | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | — | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Plastic Teeth Model · Resin Denture Tooth | — | — |
| anaxdent North America | United States | Lister | ACRYLINE · 3Delta UNlimited · anaxcam The Show | — | — |
| Shenzhen Upcera Digital Dental Technology Co., Ltd | China | Foreign exporter | PMMA Blocks, FLNT Temp, FLNT Base | — | — |
| Sanicure BV | Netherlands | Foreign exporter | RESIN, DENTURE, RELINING, REPAIRING, REBASING | — | — |
| DDS Dentalab | United States | Repacker / relabeler | DENTURE · TEETH | — | — |
| Shenzhen Upcera Dental Technology Co., Ltd | China | Foreign exporter | PMMA Blocks, FLNT Temp, FLNT Base | — | — |
| Zapalign LLC | United States | Repacker / relabeler | RESIN, DENTURE, RELINING, REPAIRING, REBASING | — | — |
| Garreco, LLC. | United States | Manufacturer | — | — | — |
| Universal Orthodontic Lab, Inc. | United States | Manufacturer | — | — | — |
| Purple Dental Tech | United States | Repacker / relabeler | Exquisite Dental Tech · Purple Dental Lab | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Partial Pre-fab Denture · Plastic Denture Tooth · Resin Denture Tooth | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | G-CAM · PMMA | — | — |
| Primotec LLC | United States | Repacker / relabeler | REF-LINE | — | — |
| Mountain Dental Lab Service Inc | United States | Repacker / relabeler | DENTSPLY INTL | — | — |
| Olson Dental Laboratory, Inc. | United States | Repacker / relabeler | acrylic · resin · Teeth | — | — |
| Showcase Dental Lab LLC | United States | Contract manufacturer | Denture, Acrylic Teeth, Denture, Partial Denture | — | — |
| star dental lab | United States | Repacker / relabeler | alloy chrome cobalt base metal for dentures · crown and bridge porcelain teeth · crown and bridge temporary resin · partial and full dentures plastic teeth · +2 | — | — |
| Arvit Dental Laboratory Inc. | United States | Repacker / relabeler | Teeth, Denture, Plastic | — | — |
| Global Dental Technologies, Inc. | United States | Repacker / relabeler | Denture, Plastic, Teeth | — | — |
| Henry Schein Canada, Inc. | Canada | Foreign exporter | DB + POS EACH · DB+ 20 ANT FULL SET · DB+ 20 POS FULL SET · DB+ ANT EACH | — | — |
| Dentac, LLC | United States | Repacker / relabeler | dentac denture · denture | — | — |
| Fire Dental Studio, LLC | United States | Repacker / relabeler | FIRE ELM - Denture, plastic, teeth | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Premiere 1 Dental Laboratory, LLC | United States | Repacker / relabeler | Preformed Denture Teeth, Partially Fabricated Denture, Partially Fabricated Partial Denture, · Denture, Partial, Acrylic Teeth, Plastic, Plastic Teeth | — | — |
| Gregory Weil Dental Ceramic Studio, Inc. | United States | Repacker / relabeler | Denture | — | — |
| Innovation MediTech GmbH | Germany | Contract manufacturer | — | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Snowrock USA | United States | Repacker / relabeler | Snow Rock | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | KAITONG/ROYAL SYNTHETIC POLYMER TEETH | — | — |
| CeraMax Dental Art, LLC | United States | Repacker / relabeler | Denture | — | — |
| Jack Jack LLC | United States | Lister | — | — | — |
| JSB Dental, Inc. | United States | Repacker / relabeler | D496503 | — | — |
| OTC Dental | United States | Repacker / relabeler | DenSureFit · DenSureFitPro | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Uhler Dental Products & Solutions LLC | United States | Repacker / relabeler | New Stetic | — | — |
| A.D.L. Dental Lab | United States | Repacker / relabeler | — | — | — |
| Karlin Dental Distributors | Canada | Private-label distributor | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where denture materials 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 |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI | 2 | 872.3760 | 108 | 335 |
| Teeth Plastic DentureELM | 2 | 872.3590 | 61 | 55 |
| Resin Denture Tooth Preformed Additively ManufacturedPZY | 2 | 872.3590 | 35 | 1 |
| Denture Preformed (Partially Prefabricated Denture)EKO | 2 | 872.3600 | 19 | 4 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Aug 2026 | K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 13 Aug 2026 | K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 31 Jul 2026 | K262681 | NanoCeram Resin | 3BFAB Teknoloji AS | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jul 2026 | K262300 | Denture Base Resin V2 | Formlabs Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 1 Jul 2026 | K261474 | DENTCA Tru Flexible | Dentca, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 2 Jun 2026 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 6 May 2026 | K260376 | Denture Base | Shandong Huge Dental Material Corporation | EBI Rebasing Repairing Relining Denture Resin |
| 25 Nov 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Nov 2025 | K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 20 Nov 2025 | K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 30 Oct 2025 | K252430 | Freeprint® denture flex | Detax GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 17 Sep 2025 | K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | EBI Rebasing Repairing Relining Denture Resin |
| 25 Jun 2025 | K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 3 Jun 2025 | K242897 | Partial Flex | Clemde SA DE CV | EBI Rebasing Repairing Relining Denture Resin |
| 20 May 2025 | K250489 | FP3D | Keystone Industries | EBI Rebasing Repairing Relining Denture Resin |
| 29 Apr 2025 | K250617 | Apex Flex | SprintRay Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 11 Apr 2025 | K243356 | Asiga DentaBASE | Asiga | EBI Rebasing Repairing Relining Denture Resin |
| 31 Mar 2025 | K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd | EBI Rebasing Repairing Relining Denture Resin |
| 23 Dec 2024 | K243103 | Denture Base | Riton 3D Technology Co., Ltd | EBI Rebasing Repairing Relining Denture Resin |
| 17 Dec 2024 | K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 22 Nov 2024 | K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBI Rebasing Repairing Relining Denture Resin |
| 24 Oct 2024 | K241089 | KeyPrint KeyDenture Base | Keystone Industries | EBI Rebasing Repairing Relining Denture Resin |
| 12 Sep 2024 | K241493 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 4 Sep 2024 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 20 Jun 2024 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak | EBI Rebasing Repairing Relining Denture Resin |
| 5 Mar 2024 | K233859 | BASIS FLOW II | Yamahachi Dental Mfg. Co. | EBI Rebasing Repairing Relining Denture Resin |
| 23 Feb 2024 | K233995 | Ivotion Base Print | Ivoclar Vivadent, AG | EBI Rebasing Repairing Relining Denture Resin |
| 27 Nov 2023 | K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | EBI Rebasing Repairing Relining Denture Resin |
| 20 Oct 2023 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 20 Oct 2023 | K231388 | NextDent Base | Vertex-Dental B.V. | EBI Rebasing Repairing Relining Denture Resin |
| 5 Sep 2023 | K232691 | Polibond | Zirkonzahn Srl | EBI Rebasing Repairing Relining Denture Resin |
| 16 Aug 2023 | K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | EBI Rebasing Repairing Relining Denture Resin |
| 14 Jul 2023 | K230445 | OnX Tough | SprintRay Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 23 Jun 2023 | K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 12 May 2023 | K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | EBI Rebasing Repairing Relining Denture Resin |
| 13 Apr 2023 | K230098 | Trusana | Myerson LLC | EBI Rebasing Repairing Relining Denture Resin |
| 6 Apr 2023 | K230341 | ACRIFIX | Deltamed GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 17 Mar 2023 | K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd | EBI Rebasing Repairing Relining Denture Resin |
| 17 Nov 2022 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 10 Nov 2022 | K221678 | SprintRay High Impact Denture Base | SprintRay Inc. | EBI Rebasing Repairing Relining Denture Resin |