Miscellaneous devices · 21 CFR 872 Subpart G
Suction Operatory Unit
FDA device type “Unit, Suction Operatory”.
- Companies listing it
- 7058 makers
- Brands and models
- 116
- 510(k) clearances
- 30 in five years
- FDA name
- Unit, Suction Operatory
510(k) clearances per year, 1976–2026
Companies that list EBR
70 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Aerosol Suction System; C-AS; C-AS1 | 6 | 2025 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Suction machine (model: suction 10, suction 20) | 5 | 2026 |
| Guilin Refine Medical Instrument Co., LTD. | China | Maker | External Oral Aerosol Suction System | 3 | 2026 |
| Firstar Dental Company | United States | Maker | — | 3 | 2026 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Vacuum unit | 2 | 2026 |
| A-dec, Inc. | United States | Maker | A-dec 362R Support System, Refurbished · A-dec 363R Pedestal MT Support System, Refurbished · A-dec 461R Support System, Refurbished · A-dec 561R Support System, Refurbished · +1 | 68 | 2022 |
| Midmark Corporation | United States | Maker | Midmark Cuspidor | 7 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Dental Extraoral Suction unit · Infinity Endo File Removal Kit | 1 | 2025 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) · Suction System, Dry Vaccum System(model: DV600,DV800,DV1000,DV1500) · Suction System, Dry Vaccum System(model: SV300,SV400,SV600,SV800,SV1000,PV100,V20,V40,V60,V80,V100) · Suction System, Dry Vaccum System(model: WV200,WV400,WV600) | 1 | 2026 |
| Zumax Medical Co., Ltd. | China | Maker | DSD-01 Dental Suction Unit | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Extraoral Suction System | 1 | 2023 |
| Beaverstate Dental, Inc. | United States | Maker | A-4550 · A-5000 · A-5032 · A-5124 · +10 | 2 | 1995 |
| Sable Industries, Inc. | Canada | Maker | HVE/SE Valve (Suction) | 2 | 2009 |
| Ritter Concept GmbH | Germany | Maker | Ritter | 1 | 2016 |
| Nanning Baolai Medical Instrument Co., Ltd. | China | Maker | Extraoral suction system model: ESS1 | 1 | 2015 |
| Micrylium Laboratories Inc. | Canada | Maker | BioVAC | 1 | 1998 |
| Osung Mnd Co Ltd | South Korea | Maker | SN3STS · SN3STSL · SN3TI · SN4STS · +15 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | UNIT, SUCTION OPERATORY | — | — |
| Dental Studio | South Korea | Maker | Easy Surgical 360 Suction · TITANIUM SUCTION SET A TYPE · TITANIUM SUCTION SET B TYPE | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Dental Extraoral Suction unit | — | — |
| Medcave Private Limited | Pakistan | Maker | Suction Operatory | — | — |
| Aesculap AG | Germany | Maker | Aesculap | — | — |
| Beyes Dental Inc | Canada | Maker | DuraMax Extraoral Suction System - Aerosol Control, Models: X1, X2, X3, X4, X5, X6 X7 | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | UNIT, SUCTION OPERATORY | — | — |
| Surgicrafts | Pakistan | Maker | EBR / UNIT, SUCTION OPERATORY | — | — |
| Maquira Industria de Produtos Odontologicos | Brazil | Maker | ODONTOLOGICAL ASPIRATOR WITH BONE COLLECTOR · SURGICAL ASPIRATOR | — | — |
| Zirc Dental Products Inc | United States | Maker | Water Wise Starter Kit, Water Wise Replacement Bottle | — | — |
| G.S.T. Corporation Limited | India | Maker | Gold Cross · GSTC · Heuer | — | — |
| Omnia SRL | United States | Maker | ASPIRATION SYSTEM | — | — |
| Greens Surgicals Private Limited | India | Maker | Dr. Vinay Kumar | — | — |
| Dufner Instrumente GmbH | Germany | Maker | SUCTION UNIT | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | AMALGAM SEPARATOR · Medical Suction Unit | — | — |
| iSonic Inc. | United States | Maker | iSonic | — | — |
| Ascentcare Dental Products | United States | Maker | VacuLUX Adapter | — | — |
| Dntlworks Equipment Corp. | United States | Maker | NitrousVac portable vacuum unit | — | — |
| QSA Surgical | Pakistan | Maker | — | — | — |
| Allied Medical LLC | United States | Maker | GOMCO PUMPS | — | — |
| Foshan Gladent Medical Instrument Co.,Ltd. | China | Maker | — | — | — |
| Jiangsu Saikang Medical Equipment Co., Ltd | China | Maker | Electric suction unit · Manual suction unit · Sputum suction unit | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| ITM Industria de Tecnologias Medicas LTDA | Brazil | Maker | Suction Operatory Unit | — | — |
| Jiangsu Yongfa Medical Equipment Technology Co. Ltd. | China | Maker | Electric Suction Unit · Manual Suction Unit · Sputum Suction Unit | — | — |
| Apothecaries Sundries Mfg Pvt Ltd | India | Maker | ASCO · Comfosmart | — | — |
| ARI Medical Technology Co., Ltd. | China | Maker | ARI Medical Suction Unit | — | — |
| ChangShu Beyond Medical Device Co., Ltd. | China | Maker | beyond · wound drainage reservoir | — | — |
| Jiangsu Rooe Medical Technology Co., Ltd. | China | Maker | ROOE Electric Suction Unit; Manual Suction Unit; Sputum Suction Unit | — | — |
| Koros USA Inc | United States | Maker | UNIT, SUCTION OPERATORY | — | — |
| Narang Medical Ltd | India | Maker | NET | — | — |
| dentalree.com International Inc | United States | Maker | Dental Extraoral Suction unit | — | — |
| E-Vac Corp. | United States | Maker | E-VAC TIP | — | — |
| Endocraft LLC | United States | Maker | Suction Cannula | — | — |
| Shanghai No. 2 Medical College Duhang Medical Equipment Fact | China | Maker | Sputum suction unit, Manual suction unit, Electric suction unit | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| GeoTec, Inc. | United States | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Tonglu Wanhe Medical Instrument Co., Ltd. | China | Maker | — | — | — |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | SuperbAir Air Compressor | 3 | 2007 |
| Aesculap, Inc. | United States | Lister | SUCTION UNIT | 2 | 2006 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | dental suction · dental unit | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | STAR5 | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | C-AS1 | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Straw Aspirator Kit | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Nordent MFG., Inc. | United States | Contract manufacturer | Nordent Suction Tips | — | — |
| PDT Inc. | United States | Contract manufacturer | Bone Aspirator | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) · Suction System, Dry Vaccum System (model: SV300,SV400,SV600,SV800,SV1000,PV100,V20,V40,V60,V80,V100) · Suction System, Dry Vaccum System (model: V600,DV800,DV1000,DV1500) | — | — |
| DeRoyal Industries Inc | United States | Contract manufacturer | Unit, Suction Operatory - DeRoyal | — | — |
| Saferlife Products Co.,Ltd. | China | Repacker / relabeler | Suction pump · Suction unit | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 11 Apr 1994 | K925367 | A-DEC 7284 CUSPIDOR, CASCADE | A-dec, Inc. |
| 12 Mar 1986 | K860058 | DENPAX | Nissho Iwai American Corp. |
| 8 Apr 1977 | K770600 | OROPHARYNGEAL SUCTION AIRWAY | W.H. Wall, D.D.S. |
Official records: FDA product classification for EBR · 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