Prosthetic devices · 21 CFR 872 Subpart D
Rebasing Repairing Relining Denture Resin
FDA device type “Resin, Denture, Relining, Repairing, Rebasing”.
- Companies listing it
- 144108 makers
- Brands and models
- 507
- 510(k) clearances
- 33549 in five years
- FDA name
- Resin, Denture, Relining, Repairing, Rebasing
510(k) clearances per year, 1976–2026
Companies that list EBI
144 companies currently list this device type with FDA.
| 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 | 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) · +12 | 56 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | Additively Manufactured Denture Resin · Denture Base Resin · Freeprint denture · 3D Printing Material Denture Base | 16 | 2026 |
| Voco GmbH | Germany | Maker | CediTEC · CediTEC DB · GrandTEC · Quick Up · +4 | 117 | 2026 |
| 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) · +6 | 8 | 2026 |
| GC America Inc. | United States | Maker | Coe Comfort · Coe Lubricant · Coe Soft · Coe Soft Print · +30 | 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 · +3 | 37 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | Denture Base Resin DT20 | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | Aesthetic Cold · Aesthetic Hot · Aesthetic Intensiv Color · AutoPlast · +21 | 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 · +2 | 8 | 2026 |
| Deltamed GmbH | Germany | Maker | ACRIFIX Bonder · ACRIFIX rosa-opak · ACRIFIX rosa/pink · ACRIFIX rosa/pink Set · +9 | 6 | 2024 |
| LuxCreo Inc. | United States | Maker | FPD Reisn | 4 | 2026 |
| 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 | 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 | 8 | 2026 |
| Vertex-Dental B.V. | Netherlands | Maker | Castapress · Castavaria · Ceramill Denture 3D+ · Hot Curing 20 Min Type C · +8 | 7 | 2024 |
| Dentca, Inc. | United States | Maker | DENTCA Base Hi-Impact · DENTCA Base Premium · DENTCA Denture Base II/DENTCA Try-In | 6 | 2026 |
| Pac-Dent Inc. | United States | Maker | Rodin 3D Resin Denture Base | 5 | 2022 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Basis · BASIS FLOW II · Basis Hi · Basis Twin Cure · +4 | 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 · +9 | 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 | 2 | 2026 |
| Asiga | Australia | Maker | DentaBASE | 2 | 2025 |
| Clemde SA DE CV | Mexico | Maker | PF Keep / Cad Cam Peek Block | 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 | 14 | 2023 |
| Dreve Dentamid GmbH | Germany | Maker | FotoDent denture | 6 | 2025 |
| New Stetic, SA | Colombia | Maker | Duracryl · EZ-Cryl · Fidelity · Novacryl · +6 | 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 | 1 | 2024 |
| 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 · +3 | 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 |
| 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 · +1 | 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 |
| 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 | 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 · +10 | 2 | 2021 |
| Manufacturera Dental Continental | Mexico | Maker | Bisacryl NicTone · Nic Tone Acrylic Resins · Nic Tone PolyCril · Nic Tone Selfcure Liquid | 2 | 2001 |
| Polident d.o.o. | Slovenia | Maker | Pink CAD/CAM Disc | 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 |
| Union Dental S.A. | Spain | Maker | ANAXDENT PMMA BLANK · CORiTEC PMMA DISC Monolayer & Multilayer · IDODENTINE BLOCK · IDODENTINE DISC · +2 | 1 | 2015 |
| The Myerson Company Limited | Trinidad & Tobago | Maker | Dentivera · DuraCetal · DuraFlex · PermaSoft · +5 | 1 | 2017 |
| National Dentex LLC | United States | Maker | SomnoDent MAS | 1 | 2012 |
| Wright Health Group | United Kingdom | Maker | Dentavit · Dentorium | 1 | 2013 |
| Valplast Intl. Corp. | United States | Maker | Valplast · Valplast 110N | 1 | 2006 |
| Perflex Ltd | Israel | Maker | ACRYFREE BIOSENS FLEXINYLON · T-Crystal | 1 | 2015 |
| Talon Acrylics, Inc. | United States | Maker | Talon & Revere · Talon Thermoplastic Polymer/Revere Thermoplastic Polymer | 1 | 2007 |
| 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 | — | — |
| IDOC Dental Lab | United States | Maker | Lucitone Digital Print | — | — |
| Evoden Industria Comercio Importacao e Exportacao de Produto | Brazil | Maker | Evoblock · Perleon | — | — |
| 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 | — | — |
| 3BFAB Teknoloji Anonim Sirketi | Türkiye | Maker | Dentafab NanoCeram | — | — |
| UFP Technologies, Inc. | United States | Maker | Tooth Shade Resin Material | — | — |
| Ningbo Sezen Technology Co., Ltd. | China | Maker | FPD Reisn | — | — |
| Proto3000 Inc. | Canada | Maker | Vertex-Dental B.V. | — | — |
| Bird-X, Inc. | United States | Maker | Coldpac Denture Acrylic | — | — |
| Fricke Dental MFG. Co. | United States | Maker | HI-I, Vitacrilic, Vitalon, Pouresin, Profit, Polycast, Acupac, R&R | — | — |
| MyoHealth Technologies, LLC | United States | Maker | Myoaligner Appliance | — | — |
| 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 | — | — |
| Esstech, Inc | United States | Maker | FP3D | — | — |
| Makevale Ltd. | United Kingdom | Maker | Excel Formula Acrylics | — | — |
| Vynacron Dental Resins, Inc. | United States | Maker | VYNACRON | — | — |
| CFS Dental Inc. | United States | Maker | — | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| Shen FU Arts Lab | China | Maker | — | — | — |
| Shofu Inc | Japan | Contract manufacturer | DENTADISC | 96 | 2025 |
| 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 |
| 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 |
| Dental Manufacturing S.p.A. | Italy | Foreign exporter | ACRY PRINT 3D RU-004 DENTURE HI · ACRY PRINT 3D RU-005 GUIDE | 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 |
| 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 · +1 | — | — |
| 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 · +1 | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Coe Comfort · Coe Soft · Reline kit / Soft | — | — |
| Dentatus AB | Sweden | Manufacturer | TufLink | — | — |
| anaxdent North America | United States | Lister | ACRYLINE · 3Delta UNlimited | — | — |
| 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 | — | — |
| 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 | — | — | — |
| Purple Dental Tech | United States | Repacker / relabeler | Exquisite Dental Tech · Purple Dental Lab | — | — |
| Dental Plus USA, LLC | United States | Repacker / relabeler | G-CAM · PMMA | — | — |
| Mountain Dental Lab Service Inc | United States | Repacker / relabeler | DENTSPLY INTL | — | — |
| Olson Dental Laboratory, Inc. | United States | Repacker / relabeler | acrylic · resin | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Innovation MediTech GmbH | Germany | Contract manufacturer | — | — | — |
| Snowrock USA | United States | Repacker / relabeler | Snow Rock | — | — |
| OTC Dental | United States | Repacker / relabeler | DenSureFit · DenSureFitPro | — | — |
| Karlin Dental Distributors | Canada | Private-label distributor | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Aug 2026 | K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. |
| 13 Aug 2026 | K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. |
| 31 Jul 2026 | K262681 | NanoCeram Resin | 3BFAB Teknoloji AS |
| 8 Jul 2026 | K262300 | Denture Base Resin V2 | Formlabs Inc. |
| 1 Jul 2026 | K261474 | DENTCA Tru Flexible | Dentca, Inc. |
| 2 Jun 2026 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. |
| 6 May 2026 | K260376 | Denture Base | Shandong Huge Dental Material Corporation |
| 25 Nov 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo Inc. |
| 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. |
| 20 Nov 2025 | K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. |
| 30 Oct 2025 | K252430 | Freeprint® denture flex | Detax GmbH |
| 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. |
| 25 Jun 2025 | K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. |
| 3 Jun 2025 | K242897 | Partial Flex | Clemde SA DE CV |
| 20 May 2025 | K250489 | FP3D | Keystone Industries |
| 29 Apr 2025 | K250617 | Apex Flex | SprintRay Inc. |
| 11 Apr 2025 | K243356 | Asiga DentaBASE | Asiga |
| 31 Mar 2025 | K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd |
| 23 Dec 2024 | K243103 | Denture Base | Riton 3D Technology Co., Ltd |
| 17 Dec 2024 | K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. |
| 22 Nov 2024 | K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd |
| 24 Oct 2024 | K241089 | KeyPrint KeyDenture Base | Keystone Industries |
| 12 Sep 2024 | K241493 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. |
| 4 Sep 2024 | K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. |
| 20 Jun 2024 | K240688 | RODIN Titan 3D Resin | Belport Company, Inc., Gingi-Pak |
| 5 Mar 2024 | K233859 | BASIS FLOW II | Yamahachi Dental Mfg. Co. |
| 23 Feb 2024 | K233995 | Ivotion Base Print | Ivoclar Vivadent, AG |
| 27 Nov 2023 | K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV |
| 20 Oct 2023 | K231578 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. |
| 20 Oct 2023 | K231388 | NextDent Base | Vertex-Dental B.V. |
| 5 Sep 2023 | K232691 | Polibond | Zirkonzahn Srl |
| 16 Aug 2023 | K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC |
| 14 Jul 2023 | K230445 | OnX Tough | SprintRay Inc. |
| 23 Jun 2023 | K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH |
| 12 May 2023 | K222489 | Harvest Printable Resin | Harvest Dental Products, LLC |
| 13 Apr 2023 | K230098 | Trusana | Myerson LLC |
| 6 Apr 2023 | K230341 | ACRIFIX | Deltamed GmbH |
| 17 Mar 2023 | K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd |
| 17 Nov 2022 | K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. |
| 10 Nov 2022 | K221678 | SprintRay High Impact Denture Base | SprintRay Inc. |
| 21 Sep 2022 | K220236 | V-Print dentbase | Voco GmbH |
| 14 Sep 2022 | K220979 | SprintRay Denture Base | SprintRay Inc. |
| 12 Aug 2022 | K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation |
| 11 Aug 2022 | K222414 | TERA HARZ DENTURE | Graphy, Inc. |
| 7 Jul 2022 | K220771 | Stratasys TrueDent | Stratasys Ltd |
| 5 Jul 2022 | K220743 | CediTEC | Voco GmbH |
| 22 Jun 2022 | K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. |
| 4 Mar 2022 | K213994 | Flexible Block | Shandong Huge Dental Material Corporation |
| 10 Jan 2022 | K212541 | 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix | Deltamed GmbH |
| 28 Jul 2021 | K210189 | Pac-Dent Denture Base Resin | Pac-Dent Inc. |
| 5 May 2021 | K210298 | GR-14 Resin System | pro3dure medical GmbH |
| 30 Mar 2021 | K203641 | E-Denture Pro | Envisiontec GmbH |
| 23 Mar 2021 | K210828 | DIOnavi-Denture02 | DIO Corporation |
| 19 Nov 2020 | K200580 | FotoDent denture | Dreve Dentamid GmbH |
| 16 Nov 2020 | K200461 | Freeprint denture | Detax GmbH & Co. KG |
| 22 Oct 2020 | K193623 | DIOnavi-Denture | DIO Corporation |
| 18 Aug 2020 | K191591 | BB Base 3D printing resin for denture base | Enlighten Materials Co., Ltd. |
| 31 Jul 2020 | K190790 | Flex Fit | Dk Mungyo Corporation |
| 29 Jan 2020 | K191926 | VITA VIONIC Bond | Vita Zanhnfabrik H. Rauter GmbH Co. |
| 1 Nov 2019 | K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. |
| 4 Oct 2019 | K190940 | Tokuyama Rebase III | Tokuyama Dental Corporation |
| 26 Aug 2019 | K191427 | Halley resin system | Dentsply Sirona, Inc. |
| 24 Apr 2019 | K190043 | Halley resin | Dentsply Sirona, Inc. |
| 21 Dec 2018 | K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | Juvora, Ltd. |
| 18 Dec 2018 | K182422 | Lucitone Denture Base Materials | Dentsply Sirona, Inc. |
| 12 Oct 2018 | K181220 | Juell 3D Volo Base | Park Dental Research Corp |
| 27 Apr 2018 | K172764 | Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) |
| 16 Jan 2018 | K172683 | Yamahachi Pink CAD/CAM Disk | Yamahachi Dental Mfg. Co. |
| 2 Nov 2017 | K172407 | Duracetal | The Myerson Company Limited |
| 2 Oct 2017 | K170375 | Nobilplast Denture Resin | Cmp Industries, LLC |
| 5 Jul 2017 | K170549 | TOKUYAMA CUREGRACE | Tokuyama Dental Corporation |
| 30 Jun 2017 | K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. |
| 31 May 2017 | K163482 | Orthodontic Acrylic 2 | Lang Dental Manufacturing Co., Inc. |
| 13 Mar 2017 | K162654 | mollosil plus | Detax GmbH & Co. KG |
| 3 Mar 2017 | K162044 | Dentca Denture Base II | Dentca, Inc. |
| 13 Feb 2017 | K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora, Ltd. |
| 6 Oct 2016 | K161330 | Pour Acrylic | Dentsply Sirona, Inc. |
| 28 Sep 2016 | K153546 | PINK CAD/CAM disc | Polident d.o.o. |
| 2 Sep 2016 | K152981 | JET SET 4 DENTURE REPAIR RESIN | Lang Dental Manufacturing Co., Inc. |
| 15 Jun 2016 | K160498 | Dentivera Milling Disc | Dental Solutions, LLC |
| 22 Apr 2016 | K153590 | AvaDent Denture Base Material | Global Dental Science |
| 22 Mar 2016 | K152051 | ClearMet | Mycone Dental Supply Co., T/A Keystone Industries |
| 3 Mar 2016 | K153253 | GC Reline II | GC America Inc. |
| 13 Nov 2015 | K152270 | Denture base resin | Korea Engineering Plastics Co., Ltd. |
| 21 Oct 2015 | K151646 | ProTech Plus | Protech Professional Products, Inc. |
| 13 Aug 2015 | K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | Wieland Dental + Technik GmbH & Co. KG |
| 21 Jul 2015 | K143033 | DENTCA DENTURE BASE | Dentca, Inc. |
| 27 May 2015 | K150511 | Coating Material | Sun Medical Co., Ltd. |
| 26 May 2015 | K150454 | Acryfree Denture Base Material and Biosens Denture Base Material | Perflex Ltd |
| 14 Apr 2015 | K143265 | Acrylic Block | Sun Medical Co., Ltd. |
| 3 Feb 2015 | K142894 | TCS Blend | Thermoplastic Comfort Systems, Inc. |
| 7 Jan 2015 | K143486 | Ufi Gel hard C | Voco GmbH |
| 15 Sep 2014 | K140758 | M-PM-DISC (PINK) | Merz Dental GmbH |
| 12 Sep 2014 | K141439 | ORTHODONTIC ACRYLIC (NOT FINALIZED) | Bisco, Inc. |
| 16 Jun 2014 | K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL | Zest Anchors, LLC |
| 29 Apr 2014 | K140146 | COMFORTSOFT SOFT DENTURE LINER SYSTEM | Whip Mix Corporation |
| 23 Jan 2014 | K132725 | JUVORA DENTQAL DISC | Juvora, Ltd. |
| 22 Aug 2013 | K130076 | PROMOLUX, PROMOLUX HI, WEROPRESS, PREMECO PCS | Merz Dental GmbH |
| 26 Jul 2013 | K130680 | ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS | Dentsoll, Inc. |
| 12 Jul 2013 | K131036 | YAMAHACHI DENTURE BASE RESINS | Yamahachi Dental Manufacturing Co. |
| 1 Mar 2013 | K123220 | VERTEX THERMOSENS RIGID | Vertex-Dental B.V. |
| 10 Jan 2013 | K123396 | I.FLEX BY TCS | Thermoplastic Comfort Systems, Inc. |
| 15 Oct 2012 | K122348 | QUARTZ SPLINT SYSTEM (UD, WOVEN, ROPE, MESH) QUARTZ SPINT RESIN QS FLOW | Dentsply Sirona, Inc. |
| 10 Apr 2012 | K113608 | DEFLEX | Nuxen S.R.L. |
| 16 Mar 2012 | K113788 | DEFLEX ACRILATO | Nuxen S.R.L. |
| 18 Nov 2011 | K111709 | FOUNDATION DENTAL RESIN | Unix-Japan Co., Ltd. |
| 4 Nov 2011 | K112397 | ORTHO-JET CRYSTAL | Lang Dental Mfg. Co., Inc. |
| 28 Oct 2011 | K112445 | SOFRELINER TOUGH S | Tokuyama Dental Corporation |
| 29 Sep 2011 | K111832 | PALADON ULTRA POWDER (PINK), PALADON ULTRA LIQUID | Heraeus Kulzer, LLC |
| 12 Sep 2011 | K111178 | JUELL SOFT CURE | Juell Dental |
| 12 Sep 2011 | K111177 | JUELL HARD CURE | Juell Dental |
| 4 May 2011 | K110440 | QUICK UP | Voco GmbH |
| 29 Apr 2011 | K110037 | PALAXPRESS ULTRA POWDER (PINK); PALAXPRESS ULTRA LIQUID | Heraeus Kulzer, LLC |
| 28 Mar 2011 | K102874 | NEW STETIC ACRYLICS | New Stetic, SA |
| 25 Mar 2011 | K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | Vertex-Dental B.V. |
| 17 Feb 2011 | K103391 | IVOBASE HYBRID, IVOBASE HIGH IMPACT | Ivoclar Vivadent, AG |
| 3 Dec 2010 | K102654 | VERTEX RAPID SIMPLIFIED | Vertex-Dental B.V. |
| 23 Nov 2010 | K102207 | FIBER FORCE | Synca Marketing |
| 29 Oct 2010 | K102347 | GRANDTEC | Voco GmbH |
| 8 Oct 2010 | K100653 | JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD | Lang Dental Mfg. Co., Inc. |
| 18 Mar 2009 | K081554 | TOKUYAMA TISSUECARE | Tokuyama Dental Corporation |
| 27 Feb 2009 | K083479 | BIOCRYL X | Great Lakes Orthodontics, Ltd. |
| 22 Jan 2009 | K081537 | CFS FLEXIBLE | Comfort and Flexible Systems |
| 17 Dec 2008 | K082180 | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 | Angelus Industria DE Produtos Odontologicos S/A |
| 25 Nov 2008 | K082153 | MAJOR.REPAIR | Major Prodotti Dentari S.P.A. |
| 17 Nov 2008 | K081981 | LANG DENTAL ACRYLIC PRIMER | Lang Dental Mfg. Co., Inc. |
| 8 Oct 2008 | K081884 | MAJOR.BASE 20 | Major Prodotti Dentari S.P.A. |
| 22 Sep 2008 | K081514 | TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER | Lang Dental Mfg. Co., Inc. |
| 20 Feb 2008 | K072851 | POLYSTAR 79 DENTURE BASE RESIN | Cmp Industries, LLC |
| 13 Dec 2007 | K073040 | SMH FLEX S | Smh Biomaterial AG |
| 9 Nov 2007 | K072479 | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD | Rapid Injection Systems Corp. |
| 5 Nov 2007 | K072580 | JET DENTURE REPAIR POWDER MEHARRY 100,454 GRAMS, JET DENTURE REPAIR PROFESSIONAL PACKAGE 100 GRAMS/118ML, 1220,30,23 | Lang Dental Mfg. Co., Inc. |
| 19 Oct 2007 | K072402 | FLEX-STAR V | Cmp Industries, LLC |
| 12 Oct 2007 | K072713 | ION DENTAL RESIN SYSTEM | Dentsply International, Inc. |
| 2 Aug 2007 | K071245 | TALON AND REVERE | Talon Acrylics, Inc. |
| 29 Mar 2007 | K070698 | COE COMFORT | GC America Inc. |
| 29 Mar 2007 | K070697 | COE SOFT | GC America Inc. |
| 8 Feb 2007 | K063626 | DURAFLEX | Cosmetic Dental Materials, Inc. |
| 12 Jan 2007 | K063170 | TENDER FIBER | Micerium S.P.A. |
| 8 Sep 2006 | K061735 | INFIBRA, MODEL 1200 | Global Dental Products, Inc. |
| 28 Jul 2006 | K061580 | ECLIPSE WAX REMOVER | Dentsply International, Inc. |
| 26 Jul 2006 | K061501 | FLEXO DENTAL RESIN MATERIAL | Aci, Inc. |
| 20 Jul 2006 | K053060 | TCS UNBREAKABLE | Thermoplastic Comfort Systems, Inc. |
| 6 Jun 2006 | K060844 | SILKLINE SOFT RELINING KIT, MODEL 28-100100 | J. Morita USA, Inc. |
| 26 Jan 2006 | K053516 | MUCOHARD | Parkell, Inc |
| 25 Jan 2006 | K053328 | BIOSPLINT SPLINTING RIBBON | Satelec |
| 21 Dec 2005 | K052780 | DENTAPLAST HOT, MODEL 16-XXX | Bredent-Products For the Dental Technician Laborat |
| 26 Oct 2005 | K052073 | FUTURAPRESS LT, N AND HP, FUTURAJET, FUTURASELF, FUTURAGEN AND FUTURACRYL 2000 | Schutz Dental GmbH |
| 7 Jul 2005 | K051358 | NATURE-CRYL HI PLUS | GC America Inc. |
| 28 Jan 2005 | K043504 | PALAIMPACT | Heraeus Kulzer, LLC |
| 5 Jan 2005 | K043295 | VERSYO.DIRECT | Heraeus Kulzer, LLC |
| 8 Dec 2004 | K042931 | TUF LINK SILICONE RELINER | Dentatus USA Ltd. |
| 25 May 2004 | K040881 | METACRYL | Great Lakes Orthodontics, Ltd. |
| 19 Mar 2004 | K034024 | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS | Bisco, Inc. |
| 21 Jan 2004 | K033632 | VARIFLEX | Great Lakes Orthodontics, Ltd. |
| 15 Jan 2004 | K033472 | TESCERA U-BAR AND BARRELS | Bisco, Inc. |
| 22 Dec 2003 | K033629 | VERSYO.BOND | Heraeus Kulzer, LLC |
| 19 Dec 2003 | K033020 | IMPAK ACRYLIC REPAIR RESIN LIQUID | Cmp Industries, LLC |
| 26 Sep 2003 | K032892 | MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl., Inc. |
| 23 Sep 2003 | K032773 | DIAMOND D HIGH IMPACT DENTURE ACRYLIC | Mycone Dental Supply Co., Inc. |
| 3 Jul 2003 | K031070 | CARBON FIBER BRIDGE, MODEL 28757 | Nobel Biocare Services AG |
| 19 Jun 2003 | K030916 | UFI GEL HARD C | Voco GmbH |
| 29 May 2003 | K030663 | TOKUYAMA SOFRELINER TOUGH | Tokuyama Dental Corporation |
| 10 Apr 2003 | K030072 | EVERSTICK PERIO | GC America Inc. |
| 2 Oct 2002 | K022641 | TOKUYAMA REBASE II | Tokuyama America, Inc. |
| 19 Jul 2002 | K021437 | SECURE SOFT | Imtec Corp. |
| 14 Jun 2002 | K021586 | SECURE RELINE/PICKUP MATERIAL | Imtec Corp. |
| 28 May 2002 | K021121 | AROMACRYL | Aromacryl, LLC |
| 13 May 2002 | K021126 | EVERSTICK ORTHO | GC America Inc. |
| 25 Jan 2002 | K013881 | RIBBOND - TRIAXIAL | Inter-Med, Inc. |
| 14 Nov 2001 | K012882 | BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 | Thermoelastic Technologies, Inc. |
| 5 Nov 2001 | K011799 | EVERSTICKNET | GC America Inc. |
| 5 Nov 2001 | K011788 | EVERSTICK | GC America Inc. |
| 5 Sep 2001 | K011820 | DENTORIUM CONVERTIBLE ACRYLIC | Nats Corp. |
| 23 Aug 2001 | K011762 | HI-WAVE; POUR-PLUS | Denplus, Inc. |
| 12 Jul 2001 | K011560 | TRUBYTE DENTURE BASE RESIN SYSTEM | Dentsply Intl., Inc. |
| 26 Jun 2001 | K011277 | HARD RELINER | S & C Polymer GmbH |
| 31 May 2001 | K010800 | VERSYO.COM | Heraeus Kulzer, LLC |
| 8 Jan 2001 | K003334 | STICK NET | GC America Inc. |
| 4 Jan 2001 | K003333 | STICK | GC America Inc. |
| 30 Aug 2000 | K002048 | JBC OPAQUE AND GLITTER | J.B.C and Co. |
| 23 Jun 2000 | K001640 | BIOSOFT RESIN | Biosoft International Corp. |
| 16 Jun 2000 | K001463 | SCHOTTLANDER ENIGMA COLOUR TONE, MODEL 0156 | Davis Schottlander & Davis, Ltd. |
| 10 Feb 2000 | K992176 | EXCEL ULTRA-HI FORMULA HEAT-CURED DENTURE BASE MATERIAL | St. George Technology, Inc. |
| 20 Jan 2000 | K993827 | UFI GEL HARD | Voco GmbH |
| 22 Dec 1999 | K993717 | ENIGMA HI-BASE DENTURE BASE MATERIAL | Davis Schottlander & Davis, Ltd. |
| 7 Oct 1999 | K991687 | MODIFICATION TO LINER II: SOFT RELINE LIQUID | Bosworth Co. |
| 6 Oct 1999 | K992956 | LUCITONE FRS FLEXIBEL DENTAL RESIN | Dentsply Intl., Inc. |
| 22 Sep 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Kay See Dental Mfg. Co. |
| 22 Sep 1999 | K991577 | NIC TONE ACRYLIC RESINS | Manufacturera Dental Continental |
| 8 Sep 1999 | K991996 | IMPACT-PLUS, IMPACT-20, DP97, DP97-20, DP-POUR AND DP-REPAIR | Denplus, Inc. |
| 9 Jul 1999 | K991774 | ACRON MC MODIFICATION | GC America Inc. |
| 28 May 1999 | K990736 | GC RELINE SOFT/EXTRA SOFT | GC America Inc. |
| 25 May 1999 | K990763 | VITRON M | Espe Dental AG |
| 20 May 1999 | K991220 | VITRON H | Espe Dental AG |
| 17 May 1999 | K990699 | ORTHO-GLOW GLITTER | Harry J. Bosworth Co. |
| 13 Apr 1999 | K983461 | UNI-FLEX RESIN | Trans-Atlantic Dental |
| 25 Mar 1999 | K990056 | JELDENT MULTICRYL | J.F. Jelenko & Co., Inc. |
| 23 Mar 1999 | K990448 | THE.R.MO.FREE | Dentamax, Inc. |
| 25 Feb 1999 | K984365 | GC UNIFAST TRAD | GC America Inc. |
Showing the 200 most recent of 335.
Official records: FDA product classification for EBI · 21 CFR 872.3760.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026