Miscellaneous devices · 21 CFR 872 Subpart G
Preformed Impression Tray
FDA device type “Tray, Impression, Preformed”.
- Companies listing it
- 301220 makers
- Brands and models
- 681
- 510(k) clearances
- 160 in five years
- FDA name
- Tray, Impression, Preformed
510(k) clearances per year, 1976–2026
Companies that list EHY
301 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | HiTray · MTM Clear Aligner Patient Case (contains only impression trays, not aligners) · MTML Impression Tray Pack · Universal Tray Adhesive | 148 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Impression Tray · R2 Tray | 30 | 2026 |
| Aidite (Qinhuangdao) Technology Co., Ltd | China | Maker | 3D Printing Material Gingiva Model · 3D Printing Material Model | 16 | 2026 |
| Voco GmbH | Germany | Maker | TRAY CLEANER · TRAYPUROL TABS-IMPRESSION TRAY | 117 | 2026 |
| Align Technology, Inc. | United States | Maker | Invisalign Impression Tray Large Lower · Invisalign Impression Tray Large Upper · Invisalign Impression Tray Medium Lower · Invisalign Impression Tray Medium Upper · +4 | 16 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | RIT-BT · RIT-LL · RIT-LU · RIT-ML · +5 | 21 | 2026 |
| GC America Inc. | United States | Maker | Check Bite Tray · Coe Sideless Impression Tray · Depressed Anterior Tray · McGowan -Winkler Impression Tray · +5 | 137 | 2026 |
| Sybron Dental Specialties | United States | Maker | Clear Impression Trays · Originate Impression Trays · Putty Spacer · Three-In-One Impression Trays · +1 | 203 | 2026 |
| Kulzer, LLC | United States | Maker | Pala Digital Denture Starter Kit · Pala Digital Denture Tray Refill · Pala Digital Impression Tray · Universal Silicone Adhesive | 37 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | DBT-A-001 · DBT-A-002 · DBT-F-001 · DBT-P1-001 · +2 | 23 | 2025 |
| Ivoclar Vivadent, AG | United States | Maker | AccuDent XD Impression Tray · AccuDent XD Tray Adhesive · Centric Tray | 94 | 2026 |
| Inter-Med, Inc. | United States | Maker | Impression Tray | 7 | 2026 |
| Dent4You AG | Switzerland | Maker | PRESIDENT Tray | 5 | 2026 |
| Shandong Huge Dental Material Corporation | China | Maker | Impression Tray · Light Curing Tray · Lower tray · Upper tray | 8 | 2026 |
| American Orthodontics | United States | Maker | Impression Tray | 44 | 2026 |
| Premier Dental Products Company | United States | Maker | AccuBite · Alfa · Bite-Tray · Emulate · +9 | 28 | 2026 |
| Young Innovations Inc | United States | Maker | Transform Trays | 23 | 2025 |
| Blue Sky Bio, LLC | United States | Maker | Blue Sky Bio Impression | 20 | 2024 |
| Shinhung Mst Co., Ltd. | South Korea | Maker | BAT00 · SPICC40 · SPICC45 · SPICC55 · +1 | 7 | 2023 |
| Centrix, Inc. | United States | Maker | — | 44 | 2025 |
| Neobiotech Co., Ltd. | South Korea | Maker | SAM Bite Plate · SAM Partially Smile Line Plate | 17 | 2024 |
| Somnomed, Inc. | United States | Maker | SomGauge | 11 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Border-Lock® Impression Trays · Clear Impression Trays · HeatWave Customizable Impression Trays · Perfectray · +5 | 8 | 2026 |
| Ttbio Corp. | Taiwan | Maker | — | 6 | 2023 |
| Dentca, Inc. | United States | Maker | DENTCA Tray | 6 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Keystone Industries | United States | Maker | Big Bite Trays · BoTrays disposable impression trays · Edentulous Impression Trays · Prehma Disposable Impression Trays · +4 | 2 | 2025 |
| Premium Plus (Dongguan) Limited | China | Maker | Impression trays, 3-IN-1 Trays | 2 | 2025 |
| HDI Inc. | South Korea | Maker | Denu Dual Tray PA; Denu Dual Tray PB; Denu Dual Tray P1; Denu Dual Tray P2 · Denu Dual Tray UL; Denu Dual Tray LL; Denu Dual Tray UM; Denu Dual Tray LM; Denu Dual Tray US; Denu Dual Tray LS | 2 | 2022 |
| Smart Denture Conversions, LLC | United States | Maker | — | 2 | 2026 |
| Coltene/Whaledent AG | Switzerland | Maker | PRESIDENT TRAY | 45 | 2022 |
| Ortho Organizers, Inc. | United States | Maker | Duralock · Redi-Lock | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Extend-O Iimpression Trays · Norm-O Impression Trays · Solay Disposable impression Trays | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | Impression Tray | 4 | 2025 |
| bredent GmbH & Co. KG | Germany | Maker | — | 3 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Impression trays/trays | 1 | 2025 |
| Chemoment Materials Co.,ltd | China | Maker | Impression tray | 1 | 2022 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | AUTOCLAVABLE IMPRESSION TRAY · MOLDEX 3 X 1 · 3D MOLDEX · 3D MOLDEX Bite | 11 | 2021 |
| Panthera Dental Inc. | Canada | Maker | Panthera D-Guide | 5 | 2020 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Dentmas · Impression Trays | 3 | 2017 |
| Advantage Dental Products, Inc. | United States | Maker | Therm Tray 1 | 3 | 1999 |
| Integra LifeSciences Corporation | United States | Maker | Miltex | 2 | 2014 |
| G&H Wire Company | United States | Maker | N/A | 2 | 2008 |
| Lascod Spa | Italy | Maker | Exploit | 2 | 2020 |
| Dental Technologies, Inc. | United States | Maker | Alpha-Dent Impression Tray | 2 | 2013 |
| Temrex Corp. | United States | Maker | BITE RELATORS · Rite Bite Trays | 2 | 2012 |
| BEGO Implant Systems GmbH & Co. KG | Germany | Maker | — | 2 | 2021 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Preformed impression tray, Plastic impression tray, impression tray | 1 | 2020 |
| Arnold Tuber Industries | United States | Maker | IMPRESSION TRAYS | 1 | 2009 |
| Biotex, Inc. | United States | Maker | Slide Bite Fork | 1 | 2021 |
| Osung Mnd Co Ltd | South Korea | Maker | TARLL · TARLU · TARML · TARMU · +51 | — | — |
| ErgoDenta ApS | Denmark | Maker | Half Non-Perforated Impression Tray, Left · Half Non-Perforated Impression Tray, Right · Half Perforated Impression Tray, Left · Half Perforated Impression Tray, Right · +20 | — | — |
| Zain's Medical Image | Pakistan | Maker | Impression Trays · Impression Trays Large, Lower, Perforated · Impression Trays Large, Lower, Solid · Impression Trays Large, Upper, Perforated · +37 | — | — |
| Metro Medical | Pakistan | Maker | Impression Trays, Bite Gauge · Impression Trays, English Pattern, Set of 8 (Lower) · Impression Trays, English Pattern, Set of 8 (Upper) · Impression Trays, For upper left jaw, For lower right jaw · +42 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Aluminium impression tray 1#/2#/3#/3#/4#/5#/6#/( a pair) perforated · Aluminium impression tray 1#2#/3# ( a pair) un-perforated · Denture duplicators · Partial impression tray (stainless steel) left · +14 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | O-Tray impression trays · "O" TRAYS | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Bite Tray K for Posterior · Color Tray Premium for Lower Blue · Color Tray Premium for Lower Gold · Color Tray Premium for Lower Pink · +38 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Impression trays/trays | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | ADJUSTABLE IMPRESSION TRAY · Autoclavable IMPRESSION tray · Disposable IMPRESSION tray · general tray · +4 | — | — |
| Technimen Skillers | Pakistan | Maker | Impression trays | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Commic Surgico | Pakistan | Maker | Impression Tray For Crown Works · Partial Impression Tray · Plastic Impression Tray · Preformed Impression Tray · +1 | — | — |
| Endo Tech Instruments | Pakistan | Maker | Dental Examination Kit of 3pcs and 4pcs · Impression Trays | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | Abutment lab analog · Ball lab analog · Fixture lab analog · Impression copin guide pin · +3 | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Bite Registration Tray · Impression Tray | — | — |
| Medcave Private Limited | Pakistan | Maker | Impression tray | — | — |
| Panorama International | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Disposable impression bite registration tray · Impression tray · Tray Cover | — | — |
| Accompany Surgical | Pakistan | Maker | Impression Tray | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Tray, impression, preformed | — | — |
| Lacigrus International | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | impression tray | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | tray, impression, preformed | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | TRAY, IMPRESSION | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Great Lakes Dental Technologies, Ltd. | United States | Maker | George Gauge · Lucia Jig | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Disposable Impression Bite Trays · Disposable Impression Trays, · Orthodontic Impression Trays | — | — |
| Denta Craft Instruments | Pakistan | Maker | Impression Tray | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Foam Strip Mouth Tray; Gel Prefilled Mouth Tray; Thermoplastic Mouth Tray; Mouth Piece; Teeth Whitening Mouth Tray | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS · TRAY, IMPRESSION | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Garish Apparels | Pakistan | Maker | Tamzon Instruments Inc. | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EHY / TRAY, IMPRESSION, PREFORMED | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Impression trays | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | impression tray · TRAY, IMPRESSION, PREFORMED | — | — |
| Harf Industries | Pakistan | Maker | Sterilization Cassette | — | — |
| Silver Plus Corp. | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Surgiscape | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Impression tray | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Foam Strip Mouth Tray;Gel Prefilled Mouth Tray;Bruxism Mouth Guard · Sports Mouth Guard;Teeth Whitening Mouth Tray,Medical Face Shield · Thermoplastic Mouth Tray /Mouth Piece | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Bite tray · Dental Tray · Plastic Tray | — | — |
| Maryam Trading | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Vedia Solutions, Division of Laxmi Dental Limited | India | Maker | Taglus Impression Tray | — | — |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | China | Maker | Anti Snore Mouth Tray · Impression Mouth Tray(For grinding,TeethWhitening) · Mouthguard | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Gel Prefilled Mouth Tray;Bruxism Mouth Guard; Thermoplastic Mouth Tray /Mouth Piece · Sports Mouth Guard;Teeth Whitening Mouth Tray,Medical Face Shield; Foam Strip Mouth Tray | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Biopsy Fine Cut Instruments | Pakistan | Maker | TRAY IMPRESSION · TRAY, IMPRESSION, PREFORMED | — | — |
| Choose Surgical Instruments | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Teeth Protector/ Mouth Guard · Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Foam Strip Mouth Tray · Gel Prefilled Mouth Tray · Mouth Piece · Teeth Whitening Mouth Tray · +1 | — | — |
| AdvanTech Plastics, LLC | United States | Maker | GDT-LLP · GDT-LMP · GDT-LSP · GDT-ULP · +2 | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Impression Trays Perforated | — | — |
| Nadir & Co. | Pakistan | Maker | Impression Trays | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Impression Trays | — | — |
| Daddy D Pro | Pakistan | Maker | Impression Trays Perforated | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Dental impression tray · Fluoride Trays Foam | — | — |
| Ortho Dental Lab, LLC | United States | Maker | Impression Tray · SmileSet Impression Tray | — | — |
| Crown Surgical Corp. | Pakistan | Maker | CROSURG | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Tray;Impression Tray; Impression Tray Base; Tray Base;Teeth-whiten tray | — | — |
| Surjex | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| one day dental partner | South Korea | Maker | kage TRAY, IMPRESSION, PREFORMED | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | Tray Impression Perforated | — | — |
| Medesy Srl | Italy | Maker | medesy | — | — |
| Meed Skills Surgical | Pakistan | Maker | Meed Skills Surgical | — | — |
| Ekong Technology Co., Limited. | China | Maker | mouth tray case · Thermoplastic Mouth Tray; Mouth Piece; Teeth Whitening Mouth Tray; Foam Strip Mouth Tray; Gel Prefilled Mouth Tray, | — | — |
| Mian Shahid Corp. | Pakistan | Maker | — | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA IMPRESSION TRAY | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | — | — |
| Tecomet | United States | Maker | PFR | — | — |
| Volgo Care International (Private) Limited | Pakistan | Maker | VOLGOCARE | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Impression Tray Base,Impression Tray | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Impression Trays - Dental, Bite Registration Trays, Fluoride Trays | — | — |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Teeth Protector · Thermoplastic Mouth Tray/ Mouth Piece/ Teeth Whitening Mouth Tray/ Foam Strip Mouth Tray/ Gel Prefilled Mouth Tray | — | — |
| SGS Export Intl. | Pakistan | Maker | Tray, Impression, Preformed | — | — |
| Spartech Instruments & Co. | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Foam Strip Mouth Tray/Gel Prefilled Mouth Tray/ Bruxism mouth guard · Thermoplastic Mouth Tray/Mouth Piece/Sports mouth guard/Teeth Whitening Mouth Tray | — | — |
| Dr Frigz International Pvt Ltd | Pakistan | Maker | All type of Impression Trays, Instruments Trays | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Accumedix, Inc. | United States | Maker | Blue Sky Bio Impression Copings | — | — |
| Armatech International | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Central Surgical Co. Pvt. Ltd. | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED, IMPRESSION TRAYS | — | — |
| Sabokay Industries | Pakistan | Maker | Tray, Impression, Performed | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Dental Impression Tray | — | — |
| Darleys Surgical Co. | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Elite Dental Lab | China | Maker | Preformed Impression Tray | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Dental mouthpiece, teeth whitening tray, anti-snore mouth guard, anti-grinding mouth guard, DSI Mouth Tray · DSI Prophy Laxis Mouth Tray | — | — |
| Hazel Enterprises | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Thermoplastic Mouth Tray, Mouth Piece/Dental mouthpiece,Teeth whitening tray; TRAY, IMPRESSION, PREFORMED | — | — |
| Surgikare | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| T.A. Walthem & Company | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Washington Surgical International | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Ashtel Studios, Inc. | United States | Maker | Dental Guard, Dental Tray | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Anti-snore mouth guard · Mouth Tray; Tray Case | — | — |
| Infirmary Medical Supplies | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Alvi Expo | Pakistan | Maker | CUTTER, WIRE | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Impression Tray | — | — |
| Hospimed Mfg | Pakistan | Maker | Impression Trays · Trays | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | Disposable Impression Tray/ Bite Registration Tray/ Fluoride Impression Tray/ Bite Whitening Tray | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | Impression, Preformed, Transform Trays | — | — |
| Aurum Group Ltd. | Canada | Maker | Bleaching tray · Custom Tray | — | — |
| Concise Enterprises | Pakistan | Maker | Impression Tray | — | — |
| Mts Brothers Surgical Instruments | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| NR Surgical Company | Pakistan | Maker | TRAY, IMPRESSION, PREFORMED | — | — |
| Sino Ortho Limited | China | Maker | bracket case | — | — |
| ASA Dental | Italy | Maker | Impression Trays | — | — |
| Shanghai D-One International Co., Ltd. | China | Maker | DENTAL GUARD | — | — |
| Trinity Sterile Inc | United States | Maker | Tray | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | Tray, impression ,Preformed | — | — |
| 3DIEMME Srl | Italy | Maker | EVOBITE | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Maker | Tray | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | Tray Cover | — | — |
| Bio-Art Equipamentos Odontologicos Ltda | Brazil | Maker | PlastPress (Positive Pressure Machine 110V) · Plastvac P7 (Vacuum Forming Machine 110V) | — | — |
| Dacheng Huaguan Dental Instruments Co., Ltd. | China | Maker | Bite Tray · impression tray | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| Libral Traders Pvt Ltd | India | Maker | Dental Impression Trays | — | — |
| Chung Song Industrial Co. | South Korea | Maker | IMPRESSION TRAY | — | — |
| Shenzhen Xiazhifeng Electronic Co., Ltd | China | Maker | Silicone orthodontic appliance | — | — |
| Weldon Instruments | Pakistan | Maker | EHY / TRAY, IMPRESSION, PREFORMED | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Tray, Impression, Preformed | — | — |
| Changzhou Shengkang Medical Instrument Co.,LTD | China | Maker | Dental tray | — | — |
| Erkodent Erich Kopp GmbH | Germany | Maker | ERKOFLEX AND ERKOPLAST | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Unip Berhad | Malaysia | Maker | IMPRESSION TRAY | — | — |
| Cixi Qimei Combination Tool Packing Factory | China | Maker | Impression Trays | — | — |
| Sobytek Instruments Co. | Pakistan | Maker | TRAYS | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Worldlabusa | United States | Maker | Impression | — | — |
| Chi Feng Co.,ltd | Taiwan | Maker | Harmony | — | — |
| Fomed Industries Inc. | China | Maker | Tray,Impression,Preformed(Impression tray) | — | — |
| Smile Dental Laboratory Company Limited | China | Maker | Custom Tray | — | — |
| Sonrisa | United States | Maker | No Stress Impress | — | — |
| TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | China | Maker | impression tray | — | — |
| Caribbean Custom Mold Inc | Dominican Republic | Maker | Sonrisa | — | — |
| Dantech Digital Dental Solutions Private Limited | India | Maker | Teeth Whitening Trays | — | — |
| DongGuan TaiFeng Sporting Manufactory Co., | China | Maker | Micro Trays | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Ningbo Welong Plastic Products Co., Ltd | China | Maker | Dental Gurad | — | — |
| North Eos Industries Inc | Taiwan | Maker | EOS BEAUTY TRAY | — | — |
| Open Airway Dental Solutions | Australia | Maker | EHY / Tray, Impression, PREFORMED · EHY / Tray, Impression, PREFORMED - Oventus Bite Fork | — | — |
| Topway Dental Laboratory Co., Ltd | China | Maker | Preformed Impression Tray | — | — |
| Vamco, LLC | United States | Maker | Jawbone Wagner Impression Tray · Wagner Tray · Wagner Universal · Wagner Universal Impression Tray | — | — |
| Guangdong Zhilianxing Precision Technology Co.,Ltd. | China | Maker | Impression Coping | — | — |
| Xiamen Zhiyuan Medical Technology Co.,Ltd | China | Maker | RESIN, MATERIAL, Impression Tray | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Dr. Walser Dental GmbH | Germany | Maker | MPI TRAY | — | — |
| Huntar Company, Inc. | United States | Maker | George Gauge | — | — |
| Jardon Eye Prosthetics, Inc. | United States | Maker | JARDON ENUCLEATION AND EVISCE · JARDON ENUCLEATION AND EVISCER | — | — |
| Orthopli Corp. | United States | Maker | — | — | — |
| Viant Medical, LLC | United States | Maker | Align Technology | — | — |
| Precision Dental Products, LLC | United States | Maker | OneBite | — | — |
| Rongxing Plastic Jurong Co.,Ltd. | China | Maker | Tray, Impression, Preformed | — | — |
| Special Projects Engineering Inc | United States | Maker | NEO Tray | — | — |
| Suzhou Jinsheng Plastic Co Ltd | China | Maker | TRAYS | — | — |
| Tianjin Tairuibosi Medical Appliance Co.,Ltd | China | Maker | Impression Foam Box | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Ada Products Company, LLC | United States | Maker | — | — | — |
| Akervall Technologies Inc. | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| DSD Planning Center SL | Spain | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Samson Innovation Corp. Ltd. | Hong Kong SAR China | Maker | — | — | — |
| Prismatik Dentalcraft, Inc. | United States | Contract manufacturer | Metal Quadrant Impression Trays, 250-Pack · Metal Quadrant Impression Trays, 50-Pack | 56 | 2026 |
| Spident Co., Ltd. | South Korea | Foreign exporter | Spident Bite Tray | 22 | 2026 |
| Zest Anchors, LLC | United States | Manufacturer | — | 26 | 2026 |
| Kettenbach GmbH & Co. KG | Germany | Manufacturer | Multi Tray | 14 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | 8 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | RSVP Impression Tray Lower · RSVP Impression Tray Upper | 27 | 2024 |
| Smylio | United States | Manufacturer | OrthoFX Tray | 4 | 2026 |
| DIO Corporation | South Korea | Foreign exporter | Wax Denture | 14 | 2023 |
| GrindGuard Inc | United States | Manufacturer | — | 1 | 2026 |
| Cavex Holland BV | Netherlands | Contract manufacturer | Cavex Bleach Transparant 1,0 mm | 26 | 2015 |
| Whip Mix Corporation | United States | Manufacturer | VERITRAY | 8 | 2016 |
| Dentamerica | United States | Repacker / relabeler | POLYBITE | 4 | 2010 |
| Storz AM Mark GmbH | Germany | Contract manufacturer | Impression tray | 2 | 2008 |
| Hager Worldwide, Inc. | United States | Manufacturer | Algilock · Miracold Plus Spray · Miratray Adhesvie Spray · Miratray Implant Advanced | 2 | 2005 |
| Aesculap, Inc. | United States | Lister | Aesculap | 2 | 2006 |
| Reliance Dental Mfg., LLC | United States | Manufacturer | Trays, Perforated Impression | 2 | 1987 |
| Directa AB | Sweden | Contract manufacturer | TRAY CLEANER | 1 | 2015 |
| Rmo, Inc. | United States | Manufacturer | RMO Impression Tray | 1 | 1990 |
| Sherpa | South Korea | Manufacturer | Excel Tray | 1 | 2011 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA #1 Lower Full Arch Perforated Stainless Steel Impression Tray · Valdent USA #1 Upper Full Arch Perforated Stainless Steel Impression Tray · Valdent USA #2 Lower Full Arch Perforated Stainless Steel Impression Tray · Valdent USA #2 Upper Full Arch Perforated Stainless Steel Impression Tray · +11 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | ABS IMPRESSION TRAY · FLUORIDE FOAM TRAY · Impression Bite Begistration Tray · impression tray · +4 | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Impression Trays | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | DENTAL IMPRESSION TRAY, BITE REGISTRATION TRAY, DISPOSABLE IMPRESSION TRAY | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Impression Trays | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Tray | — | — |
| Practicon, Inc. | United States | Manufacturer | Disposable Edentulous Trays · ECOsply Biodegradable Impression Trays · Micro Tray · Practicon Autoclavable Impression Tray | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Samtrade Supplies Inc. | Canada | Foreign exporter | Tray Adhesive | — | — |
| Summit Orthodontic Services, Inc. | United States | Repacker / relabeler | Aluminum Impression Trays · DISPOSABLE IMPRESSION TRAYS · RIGID PLASTIC IMPRESSION TRAYS · Stainless Steel Impression Trays | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus 3-IN-1 Trays with Wire Connectors · Premium Plus Dental Plastic Cpated Metal Pliable Impression Trays · Premium Plus Impression Trays · Premium Plus Rim Lock Impression Trays | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J ORTHODONTICS | — | — |
| PDT Inc. | United States | Contract manufacturer | PDT · WindowTray | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tray | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | Cargus Bite Registration Trays · MARK3® Disposable Impression Trays · MARK3® Premium Bite Registration Trays | — | — |
| LLD Care d.o.o. | Croatia | Foreign exporter | T-Loc | — | — |
| Sklar Corporation | United States | Repacker / relabeler | Impression Tray | — | — |
| Ray America Inc. | United States | Lister | RIT-LL · RIT-LU · RIT-ML · RIT-MU · +4 | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | TRAY, IMPRESSION, PREFORMED | — | — |
| battech | United States | Repacker / relabeler | Tray;lmpression Tray; Impression Tray Base; Tray Base;Teeth-whiten tray | — | — |
| Maxill Inc. | United States | Foreign exporter | Impression Tray (Dual-Arch, Krystal Klear, Classic, Anodonita, Orthodontic) | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Bite Tray · Dental Tray · Plastic Tray | — | — |
| Beaming White LLC | United States | Manufacturer | Rubber mouth tray | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | Impression tray performed, paper tray cover | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | — | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Preformed Impression Trays | — | — |
| Candid Care Co. | United States | Contract manufacturer | Candid Tray | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Impression Tray | — | — |
| Meta Dental Corp. | United States | Repacker / relabeler | IMPRESSION TRAY | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | Dental Impression Tray, Bite Registration Tray, Disposable Impression Tray | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Thermoplastic Mouth Tray/Mouth Piece/Teeth Whitening Mouth Tray/Foam Strip Mouth Tray/Gel Prefilled Mouth Tray | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Impression Trays Perforated | — | — |
| Dentonics Inc | United States | Repacker / relabeler | Master-Dent | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | UniPack Impression Tray | — | — |
| Upper Canada Soap & Candle Makers Corporation | Canada | Foreign exporter | Cedar & Sage | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Impression Tray | — | — |
| simex Medizintechnik GmbH | Germany | Repacker / relabeler | Tray, Impression, Preformed | — | — |
| HiSmile Pty Ltd | Australia | Foreign exporter | Mouth tray | — | — |
| Efficient Dental Technologies LLC | United States | Repacker / relabeler | NU-TRAY · Temp Tray | — | — |
| Ceragroup Industries | United States | Contract manufacturer | — | — | — |
| Cambrian Medical, Inc. | United States | Repacker / relabeler | cambrian medical | — | — |
| F.M. Howell & Co. | United States | Repacker / relabeler | BlueSkyBio | — | — |
| Opa Dental, LLC | United States | Repacker / relabeler | — | — | — |
| Dentall, Inc. | China | Foreign exporter | Impression | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| Reset Technology Corporation | United States | Repacker / relabeler | Reset Impression Kit | — | — |
| TD Dental Supply, Inc. | United States | Repacker / relabeler | — | — | — |
| Owl Dental | United States | Repacker / relabeler | Owl Impression Tray | — | — |
| Sweetguard Inc | United States | Manufacturer | Preformed Impression Tray | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Consolidated Metal Products LLC | United States | Repacker / relabeler | Massad | — | — |
| enCore Laboratory | United States | Manufacturer | — | — | — |
| Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. | China | Foreign exporter | — | — | — |
| Skyward Medical Devices LLC | United States | Repacker / relabeler | Impression Foam Box | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
| Worldwide Supplies Limited | Hong Kong SAR China | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 22 Jul 1994 | K942668 | O-TRAY IMPRESSION TRAYS | Dentauraum, Inc. |
| 9 Feb 1990 | K896470 | EOS IMPRESSION TRAYS | Ivoclar North America, Inc. |
| 22 Dec 1988 | K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Advantage Dental Co. |
| 14 Oct 1986 | K863836 | POST TRAY | Market Masters, Inc. |
| 18 Mar 1985 | K850776 | PREFORMED DENTAL IMPRESSION TRAYS | L.A.K. Ent., Inc. |
| 31 Jul 1984 | K842274 | F-G-P TRAY | Di-Equi Dental Products |
| 31 Jul 1984 | K842273 | CROWN INDEX TRAY | Di-Equi Dental Products |
| 13 Jul 1984 | K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Buffalo Dental Mfg. Co., Inc. |
| 27 Jun 1984 | K841323 | FUZZY TRAY | Buffalo Dental Mfg. Co., Inc. |
| 26 Dec 1983 | K833485 | IMPRESSION TUBE ADJUSTABLE | Zefr, Inc. |
| 17 Mar 1981 | K810525 | SR-IVOTRAY UNIVERSAL | J. Aderer, Inc. |
| 17 Mar 1981 | K810524 | SR-IVOTRAY SPECIAL | J. Aderer, Inc. |
| 21 Jul 1980 | K801548 | PERF-LOCK IMPRESSION TRAY | Dentsply Intl., Inc. |
| 29 Apr 1980 | K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Company |
| 28 Apr 1978 | K780678 | IMPRESSION TRAY | Rocky Mountain Orthodontics, Inc. |
| 16 Feb 1978 | K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Kerr Corporation (Danbury) |
Official records: FDA product classification for EHY · 21 CFR 872.6880.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026