Miscellaneous devices · 21 CFR 872 Subpart G
Oral Cavity Evacuator
FDA device type “Evacuator, Oral Cavity”.
- Companies listing it
- 12591 makers
- Brands and models
- 212
- 510(k) clearances
- 170 in five years
- FDA name
- Evacuator, Oral Cavity
510(k) clearances per year, 1976–2026
Companies that list EHZ
125 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Institut Straumann AG | Switzerland | Maker | ASPEO | 212 | 2026 |
| Dentsply Sirona, Inc. | United States | Maker | Aquasil Ultra Cordless digit Power Dispenser · digit Syringe Dispenser | 148 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Dr. Vortex | 30 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Ultradent Luer Vacuum Adapter | 95 | 2026 |
| Inter-Med, Inc. | United States | Maker | Aspirator / Valve Cleaning Brush · Autoclavable Replacement Heads · Elasti-Vac & Pre-Bent Elasti-Vac · Endodontic Aspirator · +10 | 7 | 2026 |
| Young Innovations Inc | United States | Maker | Biotrol Surgical Evacuation Tips · Vented Oral Evacuation Tips · Young Dental High Volume Evacuator Tips | 23 | 2025 |
| Durr Dental SE | Germany | Maker | Adapter 11 to 16mm for HVE Air Protect XL, XL Plus · Adapter 16-11 · HVE Air Protect XL Plus, gray · HVE Air Protect XL, gray · +5 | 6 | 2023 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Keystone Industries | United States | Maker | Keystone HVE Tips | 2 | 2025 |
| Premium Plus (Dongguan) Limited | China | Maker | HVE Suction Tubes · Oral evacuators | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Mobile-Vac | 2 | 2026 |
| A-dec, Inc. | United States | Maker | High Volume Evacuator (HVE) Handpiece Durr · High Volume Evacuator (HVE) including tip · 11.13700 · 11.13710 · +3 | 68 | 2022 |
| DCI International LLC | United States | Maker | HVE and SE | 1 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Vacuum Former | 1 | 2025 |
| Pacific Care Limited | Hong Kong SAR China | Maker | — | 1 | 2025 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Oral Cavity Suction Unit | 1 | 2023 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Integra LifeSciences Corporation | United States | Maker | Miltex | 2 | 2014 |
| Hager Worldwide, Inc. | United States | Maker | Bull Frog HVEs, Saliva Ejectors, and Accessories | 2 | 2005 |
| Angstrom Mfg., Inc. | United States | Maker | — | 2 | 2011 |
| J.H.Orsing AB | Sweden | Maker | CareShield · Hygosurge · Hygotip · Hygotip XL Bio · +7 | 1 | 1994 |
| Osung Mnd Co Ltd | South Korea | Maker | SN3SUS · SN3SUSL · SN3TI · SN4SUS · +8 | — | — |
| Zain's Medical Image | Pakistan | Maker | Aspirator Tips · Coupland Aspirator Tip · Coupland Suction Tube · Coupland Suction Tube, with tips · +1 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Aspirator tip (Chrome) · Aspirator tip (Stainless steel) I/II/III · Aspirator tip type IV/ type V/ type II L | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | air/ water tips · Dental irrigation syringe 3-WAY AIR WATER SYRINGE TIP · evacuation tips · High Volume HVE Tips · +5 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Vacuum Former | — | — |
| Practicon, Inc. | United States | Maker | Angle-Ease · Color Splash Saliva Ejectors · Color Tip Saliva Ejectors · ColorFlex Saliva Ejectors · +17 | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Evacuator, Oral Cavity | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Evacuator, oral cavity | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Evacuator Tip | — | — |
| SPS/Crosstex International | United States | Maker | Combo-TIp · Evacuator Tips (HVE and MaxVac Plus Combo Tip) · MaxVac Plus Combo Tip · Surgical Aspirator Tips | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Evacuator, oral cavity | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | evacuator, oral cavity | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Disposable Aspirator Tips, Evacuator Tips | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | EVACUATOR, ORAL CAVITY | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | High Volume HVE Tips | — | — |
| BH Medical Products Co., Ltd | China | Maker | HVE tips | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Aspirator tips | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Air-water syringe tip (metal & plastic), Surgical tip Air-water syringe, tip cover, High volume evacuator | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Evacuation Products | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Sani tip | — | — |
| Medline Industries, LP | United States | Maker | COVERED YANKAUER · MEDLINE EVACUATOR, ORAL CAVITY - EHZ | — | — |
| Zhejiang Jasmine Oralcare Products Co., Ltd. | China | Maker | Angle-Ease Ejector | — | — |
| Svenska Dentorama AB | Sweden | Maker | DENTORAMA ANGLE FOR ASPIRATOR TUBES · DENTORAMA ASPIRATOR TUBES | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Evacuator, Oral Cavity | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Surgical Aspirator Tip | — | — |
| Boen Healthcare Co Ltd | China | Maker | Evacuator; Oral Cavity; Surgical Aspirator Tip | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Oral Vented Evacuation Tips | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | sani tip | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Evacuator · oral cavity · surgical aspirator tip | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Evacuator, Evacuation Suction Tips, Oral Evacuation Tips | — | — |
| Dukal Corporation | United States | Maker | Dukal Evacuation Products & Accessories, including Private Label. | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Evacuator, Evacuation Suction Tips, Oral Evacuation Tips | — | — |
| EMS Electro Medical Systems SA | Switzerland | Maker | GBT FLOW CONTROL | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | EVACUATOR, ORAL CAVITY | — | — |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manu | China | Maker | Vent O Vac Evacuator Tip | — | — |
| Palmero Healthcare | United States | Maker | HVEsolo | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, PLASTIC ADAPTORS | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | Dental suction tip | — | — |
| Zyris, Inc. | United States | Maker | Isolite · Isolite 3 · Isolite Core · Isolite Core+ · +3 | — | — |
| Power Dental USA | United States | Maker | EVACUATOR, ORAL CAVITY | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | Evacuator, Oral Cavity | — | — |
| Dacheng Huaguan Dental Instruments Co., Ltd. | China | Maker | Evacuator · Oral Cavity · Surgical Aspirator Tip | — | — |
| Weldon Instruments | Pakistan | Maker | Evacuator, oral cavity | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Evacuator, Oral Cavity | — | — |
| Cixi Qimei Combination Tool Packing Factory | China | Maker | F Connector | — | — |
| Ascentcare Dental Products | United States | Maker | VacuVUE | — | — |
| Chi Feng Co.,ltd | Taiwan | Maker | AiroPur | — | — |
| DongGuan JunHai Medical Device Co., Ltd | China | Maker | Oral Cavity Evacuator | — | — |
| MedFruition Electronics Technology Co Ltd | China | Maker | Purevac® High Volume Evacuation Mirror Tips · Purevac® HVE System | — | — |
| Quality Aspirators | United States | Maker | EVACUATOR · ORAL CAVITY | — | — |
| DongGuan TaiFeng Sporting Manufactory Co., | China | Maker | Lock On S/E Valve Tips | — | — |
| IPB Inc | United States | Maker | Evacuator | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Nubird Inc. | United States | Maker | NuBird Silver Raven | — | — |
| Parts Warehouse Inc | United States | Maker | HVE and SE | — | — |
| Welmed, Inc. | United States | Maker | Evacuator, Oral Cavity | — | — |
| CPAC Equipment, Inc. | United States | Maker | SteriVac | — | — |
| ErgoMedi Ltd. | Finland | Maker | ErgoFinger | — | — |
| Iimed Medical Mexicana S. de R.L. de C.V. | Mexico | Maker | — | — | — |
| Mediplast AB | Sweden | Maker | Mediplast Evacuator, oral cavity | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Wenzhou KLF Medical Plastics Co Ltd | China | Maker | Evacuator | — | — |
| Yasco Enterprise Corp | Taiwan | Maker | Evacuator Oral Cavity | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Erchinger | Germany | Maker | — | — | — |
| Eurofins inpac Medizintechnik GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Saliva Systems | United States | Maker | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Maker | — | — | — |
| United Plastics Group(Suzhou)Co.,Ltd | China | Maker | — | — | — |
| Park Dental Research Corp | United States | Contract manufacturer | Bone Collector System | 8 | 2026 |
| CAO Group, Inc. | United States | Contract manufacturer | Aegis Plume Evacuator | 13 | 2020 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Disposable High Volume Evacuator Tips | 3 | 2007 |
| Sotera Health LLC | United States | Contract manufacturer | Safetrap Tissue Collector | — | — |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Disposable Surgical Aspirator Tip, Blue, 1/16" · Valdent USA Disposable Surgical Aspirator Tip, Green, 1/4" · Valdent USA Disposable Surgical Aspirator Tip, White, 1/8" · Valdent USA High-Volume Evacuation Tips, Assorted Colors · +1 | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL EVACUATOR · DENTAL EVACUATOR TIP | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | TOSCANA | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Evacuator Tips | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | TRAY, SURGICAL, INSTRUMENT | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Cislak Manufacturing, Inc. | United States | Contract manufacturer | Cislak · Zoll Dental | — | — |
| Premium Plus Dental | United States | Lister | Premium Plus Oral Evacuators · Premium Plus Soft Touch | — | — |
| BBF Sterilisationsservice GmbH | Germany | Contract manufacturer | FRIOS® BoneCollector Titanium Filter | — | — |
| Pascal International | United States | Contract manufacturer | ORATIP | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tips | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Canister Type Evacuation Traps · MARK3® Disposable Evacuation Traps · MARK3® HVE TIPS | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | Angle-Ease Ejector | — | — |
| Shanghai MU PROMOTIONS Co., Ltd. | China | Foreign exporter | Air-Water Syringe Tip (Metal & Plastic), Surgical Tip Air-Water Syringe, Tip Cover, High Volume Evacuator | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | EVACUATOR, ORAL CAVITY-EVACUATOR TIPS, HVE Tip Accessories, Adaptors | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Evacuator Tips | — | — |
| Midwest Dental | United States | Repacker / relabeler | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | — | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Oriental International Supplies Limited | Hong Kong SAR China | Foreign exporter | Vent O Vac, Evacuator Tip | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | EVACUATOR, ORAL CAVITY | — | — |
| Kash Sales Inc. | Canada | Foreign exporter | — | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. | China | Foreign exporter | — | — | — |
| Boone Center, Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Nov 1997 | K973248 | IMTEC BONE COLLECTOR SYSTEM | Imtec Corp. |
| 18 May 1994 | K941164 | TAP EXPRESS EJECTOR | Tap Express, Inc. |
| 15 May 1991 | K911072 | SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR | A & F Products |
| 9 Nov 1990 | K903718 | OROSCOPE MODEL NUMBER COS-100 | Cygnus Instruments, Inc. |
| 23 Jun 1989 | K892882 | DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 | Nieusma R & D, Inc. |
| 23 Jun 1989 | K892881 | DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 | Nieusma R & D, Inc. |
| 12 May 1988 | K880754 | DRI-CLAVE LIQUID KLEENZALL | Columbus Dental Mfg. Co. |
| 20 Nov 1987 | K873545 | PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT | Commercial Products & Engineering Co. |
| 12 Nov 1987 | K874401 | TITANIUM SUCTION TIP | Implant Innovations International, Inc. |
| 13 Feb 1987 | K864621 | VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER | Seldoren , Ltd. |
| 30 Oct 1986 | K863769 | EVACUATOR TIPS | The Medical Group, Inc. |
| 4 Aug 1980 | K801682 | SPACELINE HIGH VOLUME EVACUATION HANDPIE | Pacific Dental Corp. |
| 26 Jan 1979 | K782068 | MVS UNIT, MODEL SEU-8 AND DEU-8, 80 | Dentsply Intl., Inc. |
| 27 Sep 1978 | K781488 | MVS-MODEL SEU-6, DEU-6 | Dentsply Intl., Inc. |
| 27 Sep 1978 | K781486 | STERI-VAC POWER UNITS | Cpac, Inc. |
| 16 May 1978 | K780701 | DENTAL OFFICE ENVIRONMENT CONTROL UNIT | Laminaire Corp. |
| 31 Jan 1977 | K770152 | AUTO-RINSE | Dental Innovators, Inc. |
Official records: FDA product classification for EHZ · 21 CFR 872.6640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026