Prosthetic devices · 21 CFR 872 Subpart D
Resin Impression Tray Material
FDA device type “Material, Impression Tray, Resin”.
- Companies listing it
- 175132 makers
- Brands and models
- 317
- 510(k) clearances
- 300 in five years
- FDA name
- Material, Impression Tray, Resin
510(k) clearances per year, 1976–2026
Companies that list EBH
175 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | ZMD-1000B TRAY | 37 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Block-Out Resin | 22 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | 3D Printing Material Tryin · 3D Printing Try-in Material, APMR01 | 16 | 2026 |
| Voco GmbH | Germany | Maker | Individo Lux · Modellsilikon · MULTIPLE DEVICES · Profibase · +2 | 117 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | RAYDENT DM | 21 | 2026 |
| SprintRay Inc. | United States | Maker | Try-In 2 | 8 | 2026 |
| GC America Inc. | United States | Maker | Coe Tray Plastic | 137 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Emiluma · ULTRADENT LC BLOCK-OUT RESIN | 95 | 2026 |
| Kulzer, LLC | United States | Maker | dima Print Guide & Tray · Dima Print Impression Blue | 37 | 2026 |
| Hangzhou SHINING3D Dental Technology Co., Ltd | China | Maker | CX100-A1, CX100-A2, CX100-B1, CX100-BL · DT01-LT; DT01-LRP ;DT01-OP ;DT01-DK · Indirect Bonding Tray Resin IBT · Tray Resin TR01 Try-in Resin TN11 A1 Try-in Resin TN11 A2 Try-in Resin TN11 A3 Try-in Resin TN11 A3.5 · +1 | 6 | 2026 |
| Ivoclar Vivadent, AG | United States | Maker | ProArt CAD Try-In · SR-IVOLEN · SR-IVOLEN TRAY MATERIAL | 94 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | Dental Model · Impression Tray · Light Curing Tray · Lower tray · +3 | 8 | 2026 |
| Deltamed GmbH | Germany | Maker | P pro Impression Tray Green · RS VIVO Tray · 3Delta Tray · 3Delta Tray beige · +1 | 6 | 2024 |
| Kettenbach GmbH & Co. KG | Germany | Maker | Identium Adhesive · Panasil Adhesive | 14 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | 3D Printing Resin | 3 | 2026 |
| Guangzhou Heygears IMC., Inc. | China | Maker | UltraPrint Tray UV | 3 | 2026 |
| Vericom Co., Ltd. | South Korea | Maker | CUSTOM IMPRESSION TRAY RESIN | 20 | 2026 |
| Zirkonzahn Srl | Italy | Maker | — | 10 | 2023 |
| Vertex-Dental B.V. | Netherlands | Maker | Ceramill Ortho IBT · Ceramill Tray · E-IDB · NextDent Ortho IBT · +2 | 7 | 2024 |
| Pac-Dent Inc. | United States | Maker | Rodin TruModel | 5 | 2022 |
| Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | Türkiye | Maker | IMIBASE | 5 | 2022 |
| DMP Dental Industry S.A. | Greece | Maker | TRAY ADHESIVE | 3 | 2026 |
| Yamahachi Dental Mfg. Co. | Japan | Maker | Light Resin Plate · TrinDy Tray · TrinDy Try-In | 3 | 2026 |
| Keystone Industries | United States | Maker | Fastray Custom Tray Material · KeyDenture Try-In · KeyTray · Proform Blue Tray · +1 | 2 | 2025 |
| Detax GmbH | Germany | Maker | RS VIVO IBT 1000g | 2 | 2025 |
| The Belport Company, Inc. DBA Gingi-Pak | United States | Maker | — | 2 | 2026 |
| HDI Inc. | South Korea | Maker | Denu Block-Out Resin · Denu Jig Handy · Denu Jig Paste · Denu TemTooth | 2 | 2022 |
| Formlabs Inc. | United States | Maker | Custom Tray Resin · H-0600 Resin · IBT Flex Resin · IBT Resin | 2 | 2026 |
| Asiga | Australia | Maker | DentaTRAY · DentaTRAY Orange | 2 | 2025 |
| Dreve Dentamid GmbH | Germany | Maker | Drufoplast · FotoDent IBT · FotoDent tray2 | 6 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | — | 5 | 2022 |
| New Stetic, SA | Colombia | Maker | Portux 3D Printing Resin Basic · Portux 3D Printing Resin Model | 5 | 2026 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Tray Adhesive 1x 10ml USA | 4 | 2022 |
| Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | Brazil | Maker | SMART PRINT GUM MODEL COLOR PINK 250g · SMART PRINT L'AQUA MODEL 1kg · SMART PRINT L'AQUA MODEL 250g · SMART PRINT L'AQUA MODEL 500g · +13 | 1 | 2026 |
| Riton 3D Technology Co., Ltd | China | Maker | Dental Model Model H1-G · Dental Model Model H1-Y · Dental Model Model S1-G · Dental Model Model S1-Y · +9 | 1 | 2024 |
| Pacific Care Limited | Hong Kong SAR China | Maker | Bluewater Dental Innovations / Shark Tray | 1 | 2025 |
| Shenzhen Piocreat 3D Technology Co., Ltd | China | Maker | PioNext Dental Model Resin (Models: PN-IBT, PN-Try-in, PN-Splint, PN-Splint Flex) · PioNext Dental Model Resin (Models: PN-Model, PN-Model 2, PN-RD, PN-WM, PN-CIT, PN-SG, PN-Cast, PN-GM) | 1 | 2024 |
| Pulpdent Corporation | United States | Maker | Pulpdent Tray Adhesive | 107 | 2021 |
| Scientific Pharmaceuticals | United States | Maker | CURAY-FORM GEL | 73 | 2020 |
| Sterngold | United States | Maker | Stern Tek Duplicating Material · SternTek Custom Tray Impression Material | 24 | 2017 |
| S & C Polymer GmbH | Germany | Maker | — | 20 | 2009 |
| Philips Medical Systems International BV | Netherlands | Maker | EVA Tray | 16 | 2010 |
| Buffalo Dental Mfg. Co., Inc. | United States | Maker | Vacuum Forming Materials, EVA, Buff-Tuff | 11 | 1996 |
| Prime Dental Manufacturing, Inc. | United States | Maker | Prime-Dent Alginate Flavoring · Prime-Dent Tray Adhesive | 9 | 2012 |
| Lang Dental Mfg. Co., Inc. | United States | Maker | Aurora VLC · INSTANT TRAY MIX · JET TRAY RESIN | 9 | 2011 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | Henry Schein | 9 | 2017 |
| Merz Dental GmbH | Germany | Maker | M-PRINT Surgical guide HT · M-Print Tray · M-Print TryIn | 8 | 2017 |
| Whip Mix Corporation | United States | Maker | Denar Best Bite Registration · VeriTRAY | 8 | 2016 |
| Dxm Co., Ltd. | South Korea | Maker | DIBT Disposable Impression Bite Tray · Fishbone Hybrid Disposable Bite Tray | 6 | 2020 |
| Psp Dental Co., Ltd. | United Kingdom | Maker | Temp Tray | 6 | 1986 |
| Airway Management, Inc. | United States | Maker | THERMOBLEND | 5 | 2018 |
| Nanova Biomaterials Inc | United States | Maker | — | 5 | 2018 |
| Major Prodotti Dentari S.P.A. | Italy | Maker | Light-Cure.Tray · major.tray · MIT Light-Cure.Tray | 3 | 2008 |
| Hager Worldwide, Inc. | United States | Maker | Almore Surfactant · Miracast | 2 | 2005 |
| pro3dure medical GmbH | Germany | Maker | GR-11 Tray;GR-18.1 IB;STRUCTOMER IBT · GR-11.1 Tray · GR-16 Xray · GR-18.2 IB · +1 | 2 | 2021 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Dent Impression Material | 2 | 2013 |
| Enlighten Materials Co., Ltd. | Taiwan | Maker | CC tray 3D printing resin for individual tray | 2 | 2020 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Ortho Model Resin · Vacuum Forming Material, Pro Guard Mouthguard Material, Pro-form Vacuum Forming Material, Pro- Tray Custom Material · Water-Washable Ortho Model Resin · 3D printing Resin | 1 | 2020 |
| Union Dental S.A. | Spain | Maker | IDOPOL TRAYS | 1 | 2015 |
| Handae Chemical Co., Ltd | South Korea | Maker | PERFECT BITE · PERFECT-F VPS FIT CHECKER · PERFECT-F VPS HEAVY BODY · PERFECT-F VPS LIGHT BODY · +3 | 1 | 2004 |
| Seilglobal CO., Ltd | South Korea | Maker | Disposable Impression Tray · JB Tray, JBUT, JBLT, JBUTLT, JBUTR, JBLTR | 1 | 2015 |
| Wright Health Group | United Kingdom | Maker | Wrights Light Cure Tray Blanks | 1 | 2013 |
| Perflex Ltd | Israel | Maker | Thermofix , BDImpress | 1 | 2015 |
| Signor Seven International | Pakistan | Maker | Impression trays - Regular Perforated Full-Arch Stainless Steel Impression, 10 set SKU 12185 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Medcave Private Limited | Pakistan | Maker | Material Impression Tray | — | — |
| Panorama International | Pakistan | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Accompany Surgical | Pakistan | Maker | IMPRESSION TRAY · MATERIAL · RESIN | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Dental simulator · Teeth model | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Dental simulator · Teeth model | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | — | — | — |
| Denta Craft Instruments | Pakistan | Maker | IMPRESSION TRAY; MATERIAL; RESIN | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Identa Dental Material GmbH | Germany | Maker | IDENTA LC Base Plates · IDENTA LC Individual Trays | — | — |
| Solventum US LLC | United States | Maker | Incognito Indirect Bonding Tray | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Nanjing Chamlion Laser Technology Co., Ltd. | China | Maker | Chamlion-Dental Model · Chamlion-Dental Tray | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | denture teeth · Impression Trays, Bite Registration Tray | — | — |
| BH Medical Products Co., Ltd | China | Maker | bite tray · impression tray | — | — |
| NuCare LLC | United States | Maker | Bite Registration Trays · Fluoride Trays · Impression Trays | — | — |
| Vedia Solutions, Division of Laxmi Dental Limited | India | Maker | Taglus Denture Resin · Taglus Flexi Denture Resin · Taglus Model Resin C Taglus Model Resin I · Taglus Model Resin P · +6 | — | — |
| Lohar Medical Company | Pakistan | Maker | EBH / MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Nadir & Co. | Pakistan | Maker | Impression Trays Perforated | — | — |
| Mount Blonck Trading | Pakistan | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| one day dental partner | South Korea | Maker | kage MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Associated Dental Products Ltd | United Kingdom | Maker | Kemdent Godiva Red Cakes · Kemdent KemKat Impression Compound · Kemdent tracing Sticks Green · Kemdent tracing Sticks Red · +1 | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | PriZma 3D Bio Try-In | — | — |
| Suzhou laixin 3D Technology Co.,Ltd | China | Maker | Cast Resin (Cast, Cast-Wax) · Model Resin (DB Flex, DB Impact, DC, DT Dark, DT Dark Meharry 2, DT Dark Pink, DT Light, DT Light Pink) · Model Resin (DT Light Pink 2, DT, DT Pink 2, DT Pink, DT Clear Pink, Dental Teeth, Dental Teeth Plus, FlexiDenture) · Model Resin (FlexiDenture Pink, FlexiDenture Dark Pink, IBT, Print Teeth, Record model, Soft , Soft Pink, TempraTeeth) · +8 | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Material, Impression Tray, resin | — | — |
| Elite Dental Lab | China | Maker | Artificial Gingiva Materials | — | — |
| Improve Co.,limited | Hong Kong SAR China | Maker | dental models | — | — |
| dentona AG | Germany | Maker | optiprint tray 385 · optiprint tray HR | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Material, Impression Tray, resin | — | — |
| Richbolt Enterprises | Pakistan | Maker | IMPRESSION TRAYS · , S | — | — |
| Laparomed Private Limited | India | Maker | IMPRESSION TRAYS | — | — |
| Sabri Industries | Pakistan | Maker | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | IMPRESSION TRAYS, MATERIAL, RESINS, BITE TRAYS | — | — |
| PNUAdd Co., Ltd. | South Korea | Maker | JB Fork Radi+, RAYeTray · JB Tray, JB Tray Radi+ | — | — |
| Saga Dental Supply A | Norway | Maker | Impression Tray | — | — |
| Power Dental USA | United States | Maker | — | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Tray | — | — |
| Smilden Biotechnology CO., Ltd. | Taiwan | Maker | DM03 Model Resin | — | — |
| Weldon Instruments | Pakistan | Maker | EBH / MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| 3BFAB Teknoloji Anonim Sirketi | Türkiye | Maker | Dentafab Tray Resin · Dentafab Visione Resin · Powerresins Mock Up Resin | — | — |
| DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. | China | Maker | Dental Model Materials · Light Cure Composite Resin | — | — |
| SMD Dental Laboratory | South Korea | Maker | impression tray | — | — |
| Changzhou Ou Nuo Medical Equipment Co., Ltd. | China | Maker | C150, C200, MUL063, MUL076, MUL100, MUL150, MUL175, MUL200, MUL250, MUL300, MUL350, MUL400, MUL450, MUL500, MUL076 Pro, · Dental Sheet/Dental Roll: T040RC125N, T050RC125N, T063RC125N, T076RC125N, T088RC125N, T100RC125N, T040MC125N, · MUL076 Lux, C050 Pro. · T050MC125N, T063MC125N, T076MC125N, T088MC125N, T100MC125N, T040RS125N, T050RS125N, T063RS125N, T076RS125N, T088RS125N, · +3 | — | — |
| Dongguan Xinletian Dental Equipment Co., Ltd. | China | Maker | Model Resin | — | — |
| Shenzhen Yongchanghe Technology Co., Ltd. | China | Maker | Tray resin, Ortho model resin, Pro model resin, Gingiva mask resin | — | — |
| Xiamen Antinsky Industry Co., Ltd | China | Maker | Tray Resin, Ortho Model Resin, Standard Dental Model Resin, Dental Model Resin, Gingiva Resin | — | — |
| Renewmedical Co., Ltd. | South Korea | Maker | Renew Tray G-1, Renew Tray G-2, Renew Tray G-3, Renew Tray G-4, Renew Tray G-5 · Renew Tray MG-2, Renew Tray MG-4, Renew Tray MG-7, Renew Tray MP-2 · Renew Tray MP-4, Renew Tray MP-7, Renew Tray RG-1, Renew Tray RG-3 · Renew Tray P-1, Renew Tray P-2, Renew Tray P-3, Renew Tray P-4, Renew Tray P-5 | — | — |
| Apply Labwork Inc. | Taiwan | Maker | BioModeling Sand · FLEX BT TRANSLUCENT · Tray Orange | — | — |
| HO Chi Minh Branch - Vatech Viet Joint Stock Company | Vietnam | Maker | Resin-based 3D printed model | — | — |
| Huaian Tisurg Medical Instruments Co., Ltd. | China | Maker | Custom Tray Resin · H-0600 Resin · IBT Flex Resin · IBT Resin | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Shanghai Coherz Technologies Co., Ltd. | China | Maker | Dental Foil, Model Resin | — | — |
| Dentall, Inc. | China | Maker | Resin Model | — | — |
| Innovation MediTech GmbH | Germany | Maker | Impression trays | — | — |
| JamesB Dental Studio | United States | Maker | JBDS | — | — |
| Liaoning Xinaite Technology Co.,Ltd | China | Maker | Model Resin | — | — |
| Xiamen Zhiyuan Medical Technology Co.,Ltd | China | Maker | Impression Tray | — | — |
| ZiYang Rayform Technology Co., Ltd | China | Maker | Surgical Guide (RF-DB-04), Indirect Bonding Tray Resin (RF-IR-14), Model Resin (RF-ZX-03, RF-MI-2103, RF-MI-1101), · Try In Resin (RF-TIR-16), Tray Resin (RF-TR-15), Gingiva Mask (RF-YY-10), Ortho Model Resin (RF-ZJ-01), · Water Washable Model Resin (RF-ZJ-02), Soft Splint (RF-SS-13), Hard Splint (RF-HS-12) | — | — |
| Fricke Dental MFG. Co. | United States | Maker | Vitacrilic | — | — |
| Loyol New Material Suhzou Co.,Ltd | China | Maker | Model, Tray, Gingvia Mask, Casting Wax, Study Model, Ortho Model | — | — |
| Shenzhen Jinyi Medical Technology Co.,Ltd | China | Maker | Dental Models | — | — |
| TC Dental & Medical Supplies Inc | United States | Maker | Starryshine | — | — |
| Dent-A-Pharm Produktionsgesellschaft mbH | Germany | Maker | Light curing tray material | — | — |
| MEGADENTA Dentalprodukte GmbH | Germany | Maker | MEGATRAY | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| DMG Digital Enterprises SE | Germany | Maker | — | — | — |
| Shofu Inc | Japan | Contract manufacturer | DENTAPRINT | 96 | 2025 |
| Young Innovations Inc | United States | Contract manufacturer | Impression Trays · MATERIAL, IMPRESSION TRAY, RESIN- Astek | 23 | 2025 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| The Argen Corporation | United States | Contract manufacturer | Argen Tray | 11 | 2024 |
| Amann Girrbach AG | Austria | Foreign exporter | — | 3 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | DSI Implant Jig Paste Light Cure Pattern Modeling Resin · Jig Sculpting Light Cure Pattern Modeling Resin · Unilite Blockout Material | 2 | 2025 |
| Bicon, LLC | United States | Manufacturer | Hydroplastic Resin | 18 | 2015 |
| G&H Wire Company | United States | Contract manufacturer | Algi-Mate | 2 | 2008 |
| Reliance Dental Mfg., LLC | United States | Manufacturer | Duralay, Duralay Crown and Bridge, Duralay II, Duraseal, Durabase, Durabase Soft, Duraliner II, Duratray | 2 | 1987 |
| Valplast Intl. Corp. | United States | Manufacturer | Precise-Fit | 1 | 2006 |
| YETI Dentalprodukte GmbH | Germany | Manufacturer | — | 1 | 2018 |
| gebdi Dental Products GmbH | Germany | Manufacturer | — | 1 | 2009 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Resin Light-Cure Custom Tray Material, Blue · Valdent USA Resin Light-Cure Custom Tray Material, Pink | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | metal impression tray · rotary impression tray | — | — |
| Jersey Dental Supplies | United States | Repacker / relabeler | Emiluma; ULTRADENT LC BLOCK-OUT RESIN · IMPREGUM F ADHESIVE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Impression tray | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | EVACUATOR, ORAL CAVITY | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Impression Material | — | — |
| Premium Plus Dental | United States | Lister | — | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tray | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| IDOC Dental Lab | United States | Contract manufacturer | JB Fork, JB Tray | — | — |
| Ray America Inc. | United States | Lister | RAYDENT DM | — | — |
| Beaming White LLC | United States | Manufacturer | Rubber mouth tray | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | IMPRESSION TRAY,RESIN,BITE TRAY,IMPRESSION TRAY MATERIAL | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Tray Covers | — | — |
| Dental Brands for Less | Canada | Foreign exporter | DENTSPLY · Sultan | — | — |
| Garreco, LLC. | United States | Manufacturer | — | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | MATERIAL, IMPRESSION TRAY, RESIN | — | — |
| Evolve Dental Technologies, Inc. | United States | Repacker / relabeler | KöR Disposable Impression Trays · KöR EVA Sheets | — | — |
| Steel City Health Private Limited | India | Repacker / relabeler | Dental Impression Kit | — | — |
| Hongkong Loyal Beauty Technology Limited | Hong Kong SAR China | Foreign exporter | Material, Impression Tray, Resin Model | — | — |
| indigodental GmbH | Germany | Foreign exporter | — | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| BES Depot, LLC | United States | Lister | FLEX BT TRANSLUCENT · Tray Orange | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Bright Supply Inc | United States | Lister | Britedent | — | — |
| MEGA-PHYSIK Ges. fuer physikalische Messtechnik mbH & Co KG | Germany | Private-label distributor | MEGA TRAY | — | — |
| Parkside Dental Studio | United States | Repacker / relabeler | Parkside dental studio | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 26 Jan 1994 | K933745 | PERMAGEN UNIVERSAL BONDING RESIN | Bio-Systems Research |
| 18 Jun 1993 | K930487 | PALATRAY LC MINT | Heraeus Kulzer, LLC |
| 17 Nov 1992 | K923979 | LC TRAY MATERIAL | Dentsply Intl., Inc. |
| 29 Sep 1992 | K923549 | PALADISC LC | Heraeus Kulzer, LLC |
| 21 Aug 1991 | K912820 | POLYESTER RESIN HAND MOLDED TRAY | E&D Dental Products, Inc. |
| 6 Jun 1991 | K905058 | PALAVIT L | Kulzer, LLC |
| 26 Jul 1990 | K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL | Kulzer, LLC |
| 29 Jun 1990 | K901782 | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM | Productivity Training Corp. |
| 25 Apr 1989 | K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS | Advantage Dental Products, Inc. |
| 27 Jul 1988 | K881838 | MODIFIED PERMAGUM ADHESIVE | Espe GmbH (Us) |
| 9 Mar 1988 | K875257 | IMPREGUM F ADHESIVE | Espe GmbH (Us) |
| 9 Mar 1988 | K875228 | PERMADYNE ADHESIVE | Espe GmbH (Us) |
| 7 Mar 1988 | K873739 | ACRYLIC IMPRESSION TRAY MATERIALS | E&D Dental Manufacturing Co. |
| 22 Jun 1987 | K872210 | IMPRESSION TRAY | Dentsply Intl., Inc. |
| 3 Nov 1986 | K863421 | SR-IVOLEN TRAY MATERIAL | Ivoclar USA, Inc. |
| 7 Nov 1985 | K854042 | RESIN TRAY IMPRESSION MATERIAL | Dentsply Intl., Inc. |
| 6 Sep 1985 | K853093 | PSP TEMP - TRAY | Psp Dental Co., Ltd. |
| 2 Jul 1985 | K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER | The S. S. White Co. |
| 8 Feb 1985 | K844471 | VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE | Dentsply Intl., Inc. |
| 23 Jan 1985 | K850014 | HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE | Medi-Dent American, Inc. |
| 26 Jul 1983 | K831293 | SOLARCRYL CUSTOM TRAY MATERIAL | Solar Dental Co., Inc. |
| 10 Jun 1982 | K820998 | DENTRON-DIRECT-TRAY | Dentron, Inc. |
| 10 Jun 1982 | K820997 | DENTRON-EXACT - TRAY | Dentron, Inc. |
| 24 Feb 1982 | K813550 | HYBRID DENTAL PRODUCT | Dentsply Intl., Inc. |
| 14 Apr 1981 | K810686 | SR-IVOLEN | J. Aderer, Inc. |
| 12 Nov 1980 | K802751 | P-10 POSTERIOR FILLING MATERIAL | 3M Company |
| 7 Aug 1980 | K801780 | OXY CUSTOM TRAY RESIN | Oxy Dental Products, Inc. |
| 15 Jun 1979 | K790897 | QUAD IV CUSTOM IMPRESSION TRAY | Sted, Inc. |
| 26 Feb 1979 | K782153 | IMPRESSION TRAY, MDDS CUSTOM | Chayet and Sonnenrich, P.C. |
| 15 Oct 1976 | K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS | Cutter Laboratories, Inc. |
Official records: FDA product classification for EBH · 21 CFR 872.3670.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026