Miscellaneous devices · 21 CFR 872 Subpart G
Accessories Operative Dental Unit
Air compressor and vacuum unit that are connected to dental operative unit to provide compressed air and vacuum capability to power and drive other dental devices, which are attached to the dental operative unit.
- Companies listing it
- 142109 makers
- Brands and models
- 399
- 510(k) clearances
- 20 in five years
- FDA name
- Unit, Operative Dental, Accessories
510(k) clearances per year, 1976–2026
Companies that list NRD
142 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Air compressor (model: Air compressor) · Testing machine (model: HP Tester) | 5 | 2026 |
| Guilin Kevin Peter Technology Co., Ltd. | China | Maker | Intraoral Camera | 3 | 2026 |
| Firstar Dental Company | United States | Maker | — | 3 | 2026 |
| Satelec - Acteon Group | United States | Maker | C20 INTRAORAL CAMERA · C50 INTRAORAL CAMERA D | 18 | 2024 |
| Dentalez, Inc. | United States | Maker | Barracuda CV-101 · Barracuda CV-102 · Barracuda MC-201 · Barracuda MC-202 · +20 | 9 | 2026 |
| Durr Dental SE | Germany | Maker | CamX Elara · CamX Triton HD Cam · CamX Triton HD Handpiece · Mojave Mobile · +2 | 6 | 2023 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Premium Plus (Dongguan) Limited | China | Maker | Dental accessories · organisers, dispensers, holders, retainers, denture boxes · tooth fracture detector,spatula, napkin holders, instrument rings, mask extenders | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | H6000 Handpiece Cleaning and Lubrication System · Lubricant | 2 | 2026 |
| A-dec, Inc. | United States | Maker | A-dec DV10plus Dental Dry Vacuum System · A-dec DV12plus Dental Dry Vacuum System · A-dec DV5plus Dental Dry Vacuum System · A-dec DV7plus Dental Dry Vacuum System · +6 | 68 | 2022 |
| Midmark Corporation | United States | Maker | ClassicSeries · Midmark Smart Air Compressor · Midmark Smart G Vacuum · PowerAir · +3 | 7 | 2025 |
| AIOBIO Co., Ltd. | South Korea | Maker | Outer Hood | 2 | 2024 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | compressors | 1 | 2025 |
| Denjoy Dental Co., Ltd. | China | Maker | Dental Suction Unit | 1 | 2025 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | Oil Free Air Compressor(model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000) · Oil Free Air Compressor(model: UA200;UA300;UA400;UA600;UA900;UA1000;UA1200;AT800;BA800;AT20P;AT40P;AT60P;AT80P;AT100P) · Oil Free Air Compressor(model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000) · Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) · +1 | 1 | 2026 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Silent Oil free Air compressor | 1 | 2023 |
| ProEdge Dental Products | United States | Maker | BluTab Waterline Maintenance Tablets · BluTube Dental Unit Water Purification Cartridge | 1 | 2023 |
| Shanghai Handy Medical Equipment Co., Ltd. | China | Maker | HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D · Intraroral Camera | 1 | 2022 |
| SOTA Cloud Corporation | United States | Maker | SOTA Cloud Smart Camera | 1 | 2026 |
| Duerr Dental SE | United States | Maker | AirStar - AS10, AS10C, AS12, AS12C, AS21, AS21C, AS22, AS22C, AS30, AS30C, AS40, AS40C, AS50, AS50C, AS70, AS100 · AirStar Clinical Air Compressor - AS60, AS90, AS120, AS60C, AS90C, AS120C · AirStar ECO - ASE121A, ASE121D, ASE122A, ASE122D, ASE220A, ASE220D, ASE250A, ASE250D, ASE450A, ASE450D,ASE600A, ASE600D · AirStar INT - AS22INT, AS22CINT, AS50INT, AS50CINT, AS70INT · +13 | 14 | 2019 |
| Takara Belmont Corporation | Japan | Maker | QUOLIS 5000 SERIES DENTAL UNIT | 7 | 2017 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | Oral Camera; CAM-Ⅰ; CAM-Ⅱ | 5 | 2007 |
| Premium Plus International Limited | Hong Kong SAR China | Maker | Barrier Film · Dentmas · Handle Sleeves · Handpiece Sleeves · +4 | 3 | 2017 |
| Surgident Co., Ltd. | South Korea | Maker | Dental operative unit&accessories | 2 | 2019 |
| Sota Precision Optics, Inc. | United States | Maker | Claris i5HD | 2 | 2006 |
| Ritter Concept GmbH | Germany | Maker | Ritter | 1 | 2016 |
| PerioView, LLC | United States | Maker | Perio-View | 1 | 1995 |
| Guilin Yikeshi Medical Instrument Co Ltd | China | Maker | DENTURE BOX | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental bibs clip · Dental Camera · Disposable Cups, Universal Barrier Film, Universal Barrier Film Dispenser | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | compressors | — | — |
| Practicon, Inc. | United States | Maker | PRACTIFILM BARRIER FILM | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Universal barrier film | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Bib Clip · Dappen Dishes · Dental Wedge · Micro Applicator Tips · +2 | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Barrier film · Disposable Dental evacuation traps · Disposable plastic sleeves/covers · Unit, operative dental, accessories | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Barrier film · disposable Dental evacuation traps · Disposable plastic sleeves/covers · unit, operative dental, accessories | — | — |
| Tech West Inc. | United States | Maker | ACL10S2 · ACL10S5 · ACL15S5 · ACL20D5 · +47 | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Vacuum Pump · Beyes Oil-Less Air Compressors · CANAVIEW Intraoral Camera · Caremaster Automatic Handpiece Lubrication System · +1 | — | — |
| Tangshan Zhengtong Exhibition Co., Ltd. | China | Maker | Adapter · Barrier Film · Disposable Tray Covers, Paper Tray Covers, · Plastic Sleeves | — | — |
| Surgicrafts | Pakistan | Maker | NRD / Unit, operative dental, accessories | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Dappen Dish/Mixing Spatulas | — | — |
| BH Medical Products Co., Ltd | China | Maker | bib holder · cartridge gun · endo block · endo ring · +9 | — | — |
| NuCare LLC | United States | Maker | Bib Holder · Cartridge Gun · Endo Block · Endo Ring · +11 | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Handpiece Sleeves, Light Handle Covers, Tray Sleeves · Medical Face Shield, Protect Glasses · Sensor Cover, Digital X-Ray Sensor Protector | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Protect Glasses | — | — |
| Jiangsu Yabaobao Medical Instrument Co.,Ltd. | China | Maker | Disposable cups · Universal barrier film · Universal barrier film dispenser | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Protect Glasses | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Air Water Syringe Sleeves | — | — |
| TF New Material Sci and Tec Co.,ltd | China | Maker | Barrier films | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Barrier film · Full chair sleeves · Half chair sleeves · Syringe sleeves · +2 | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Universal Barrier Film | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | Unit, operative dental, accessories | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Unit, operative dental, accessories | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Universal Barrier Film,Denture Box | — | — |
| Huzhou Junda Industry Co., Ltd. | China | Maker | Sleeve sleeves | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Digital sensor cover; Half chair sleeve; Handpiece sleeve; Headrest cover; Indicator strips; Indicator tape · Intraoral camera sleeve; Micro Brush Applicators; Paper wrapper; Paper/poly pouches; Plastic Prophy; Barrier envelopes · T-bar light handle cover; X-ray head sleeve · Tray cover; Air/water syringe sleeve; Barrier film; Bendable applicator brush; Bib holder; Clear curing light cover; | — | — |
| Hefei Mlush Sanitary Products Co., Ltd | China | Maker | barrier films | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | — | — | — |
| DUNAMIS DENTAL Co., Ltd. | South Korea | Maker | SAM | — | — |
| DongGuan Magenta Medical Equipment Co., Ltd. | China | Maker | DARYOU Intraoral Camera,Intraoral camera,Dental camera · EyeCam · FocusDent intraoral dental camera · iCam · +5 | — | — |
| Mastercraft Dental Co. of Texas | United States | Maker | Companion Senior · LeSabre · MiniPro · Phoenix · +10 | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Unit, operative dental, accessories | — | — |
| Dukal Corporation | United States | Maker | Dukal Air Water Syringe Sleeves | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Unit, operative dental, dental accessories | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | Barrier Film/ Keyboard Film | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | UNIT, OPERATIVE DENTAL, ACCESSORIES | — | — |
| Wolf X-Ray Corp | United States | Maker | Perfect Shape | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Plastic Sleeve, Barrier Film, Handpiece Sleeve | — | — |
| Shengiho Enterprise Co., Ltd. | Taiwan | Maker | ACCESSORIES,Barrier Products,Plastic Pans,shield,ring,traps, · Dental Accessories, Oral cup, Water Bottle, DisposableTraps, Mixing Wells, Dappen Dishes, Brush handle, tips · DENTAL OPERATIVE U | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | ORAL IRRIGATION DENTAL · UNIT | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| MPS Project | India | Maker | MED-ARP- 9000+2000 /MED-ARP- 9000+3000/ MPS-MED-ARP-11000+3000 / · Medical AGSS Plant Model No. MPS-MED-AGP-1000+1000 / MPS-MED-AGP-1400+1400 / · Medical Air Plant Model No.MPS-MED-ARP-2000+1000 / MPS-MED-ARP-3000+1000 / MPS-MED-ARP-4000+1000 / · Medical Vacuum Plant Model No.MPS-MED-VCP-2000+2000 / MPS-MED-VCP-3000+3000 / MPS-MED-VCP-3500+3500 / · +10 | — | — |
| Jujiang Huada Medical Dressing Co., Ltd. | China | Maker | Barrier Film · Bib Clip · Dental Tray Cover · Disposable Cup | — | — |
| Omnia SRL | United States | Maker | Omnia Surgical line | — | — |
| Shenzhen Samo Technology Co.,Limited | China | Maker | Oral camera, C100,C200,C300,C400,C500,C600,C700,C800,C900 | — | — |
| Chuan Fu Medical Instrument Co., Ltd | Taiwan | Maker | CF-685 Intraoral Camera Set · CF-689 Intraoral Camera Set · CF-986 Intraoral Camera Set · CF-988 Intraoral Camera Set · +5 | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | Barrier Films · Plastic Bags · Plastic Covers | — | — |
| Anhui JM Healthcare Products Co.,Ltd. | China | Maker | Dental Sleeve, Armboard cover, Key Board Cover, Aftercare Film, Barrier Film, Plastic Bags, Plastic Covers | — | — |
| Dacheng Huaguan Dental Instruments Co., Ltd. | China | Maker | Plastic Holder · Plastic Traps | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| R.E. Morrison Equipment Inc | Canada | Maker | BaseVac · BaseVac BVA Compressors · BaseVac BVC Custom · BaseVac D-Series · +5 | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Instrument Tray Sleeves, Barrier Sleeves, Plastic Covers Plastic Covers, Syringe Sleeves, Handle Sleeves, Plastic Bags, · Scaler Sleeves, Bite Block Sleeves, Barrier Films, Handpiece Sleeves, Light/Sensor Sleeves | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | PORTABLE DENTAL UNIT | — | — |
| Greatcare 4u sdn bhd | Malaysia | Maker | Headrest cover | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS Unit, operative dental, accessories | — | — |
| Dntlworks Equipment Corp. | United States | Maker | DNTLworks | — | — |
| Fomed Industries Inc. | China | Maker | Unit, Operative Dental, Accessories (Barrier Film), Half Chair Sleeves, Headrest covers Sleeves, Tray Sleeves | — | — |
| Foshan Gladent Medical Instrument Co.,Ltd. | China | Maker | Dental Intraoral camera and Dental air compressor | — | — |
| Jiangsu Saikang Medical Equipment Co., Ltd | China | Maker | Dental unit | — | — |
| Medipack Medical Packaging Mfg Co | China | Maker | Unigard · Unigauze · Uniguard · Unipack | — | — |
| MouthWatch, LLC | United States | Maker | MouthWatch Intraoral Camera · MouthWatch Plus+ Intraoral Camera | — | — |
| Yangzhou star oral care product co., ltd. | China | Maker | — | — | — |
| Yiwu Jiekang Medical Articles Co., Ltd. | China | Maker | Barrier Sleeves | — | — |
| Dome Inc. | United States | Maker | Coronado | — | — |
| Enercon Technologies | United States | Maker | MouthWatch HD PLUS+ Intraoral Camera | — | — |
| Accs Products, Inc. | United States | Maker | ACCS Dental Accessory | — | — |
| ACME Tooling Technology Co., Ltd. | Taiwan | Maker | Intra-oral camera | — | — |
| ARI Medical Technology Co., Ltd. | China | Maker | ARI Medical Dental Unit, Dental Chair, Dental Scanner, Dental Accessorie+D7:D8s | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Hefei MT Medical Co.,ltd. | China | Maker | Dental Unit | — | — |
| Jiangsu Rooe Medical Technology Co., Ltd. | China | Maker | ROOE Medical Dental Unit, Dental Accessories | — | — |
| Minitube AB | Sweden | Maker | Intraoral Camera Sheath · Minitube X-Ray Sensor Sheath | — | — |
| ADM Tronics Unlimited, Inc. | United States | Maker | MouthWatch Intraoral Camera | — | — |
| Heaven Healthcare Co., Ltd. | China | Maker | Universal Barrier Film | — | — |
| MDX Co., Ltd. | South Korea | Maker | Air Compressor (Models: AnyAir2, AnyVac40) | — | — |
| Ningbo Yingmed Medical Instruments Co.,Ltd. | China | Maker | Barrier Film | — | — |
| Stoma Ventures LLC | United States | Maker | DOVE | — | — |
| I.C.LERCHER-Solutions GmbH | Germany | Maker | — | — | — |
| Medimaging Integrated Solution Inc. | Taiwan | Maker | — | — | — |
| Motion Dental Equipment Corp. | Taiwan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | Tray cover | 23 | 2025 |
| Keystone Industries | United States | Contract manufacturer | Prehma Barrier Film · Prehma Pro-Guard Towels · Prehma Sleeves · Simplastic Patient Drape · +3 | 2 | 2025 |
| Dentamerica | United States | Repacker / relabeler | DENTAMERICA | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | Mirage 2 Delivery System with Swivel Holder Bar- Export ONLY · Mirage Delivery System | 3 | 2007 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| Apixia, Inc. | United States | Repacker / relabeler | — | 1 | 2012 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA Brand Capsule Applier, Stainless Steel | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | barrier Film | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | AIR COMPRESSOR AND VACUUM UNIT; BARRIER FILM; HANDPIECE SLEEVES; INSTRUMENT TRAY SLEEVES; LIGHT/SENSOR SLEEVES/ POUCHES; · BARRIER SLEEVES; SURRINGE SLEEVES; DENTAL TRAY COVER, HEADREST COVER, INTRAORAL CAMERA SHEATH | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patient Towel | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | accessories | — | — |
| SPS/Crosstex International | United States | Manufacturer | Sani-Vac Evacuation System Cleaner | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | A-Series Delivery Unit (A2, A6, A12); A-Series Mobile Cart (MC-1302F, MC-1300F, MC-1302F-VAC, MC-1300F-VAC, MC-1300FC); · FLIGHT DENTAL SYSTEMS- A-Series (A12, A6S, A2, A10, A6R) | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Barrier Film | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3® Bite Blocks · MARK3® Disposable Bib Holders · MARK3® Headrest Covers Paper · MARK3® Mixing Pads | — | — |
| Maxill Inc. | United States | Foreign exporter | Maxill | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | Oil free air compressor(Model: AJAX100;AJAX200;AJAX300;AJAX400;AJAX600;AJAX800;AJAX1000) · Oil free air compressor(Model: UA200;UA300;UA400;UA600;UA900;UA1000;UA1200;BA800;AT800;AT20P;AT40P;AT60P;AT80P;AT100P) · Oil free air compressor(Model:BA100;BA200;BA220;BA300;BA400;BA600;BA1000;BA1200;AT200;AT260;AT300;AT400;AT600;AT1000) · Suction System, Dry Vaccum System (model: SP1000,SP3000,SP3000+,SP5000,SP5000+,ADS V3, ADS V5, ADS V7,ADS V10, ADS V14) · +1 | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | air water syringe sleeve, plastic tray sleeve, full/half chair sleeve, headrest cover , barrier films | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Takara Belmont Company · TOYO MEDICAL CO | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | Dam frame,overglove,Barrier apron,Waste bag,Inserts,Capsule applier,Brush handle& tips,Finger ruler,Matrix,Splash shield · DENTAL ACCESSORIES,Oral cup,Water Bottle,Vacuum Canister,Mixing Tip,Plastic Boxes,Matrices,Aligner Seater,Connector · Foam insert,Cartridge connector,Syringe tips,Intraoral tip,Plug,Core Forms,Polishing item,Tube&Plug,Indicator tape&strip · Traps,Wraps, Model cartridge,Model Former, Mixing well, Pouch, Dappen dishes, Plastic sterilization tubing, Spatula,Bowl | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | ATOMO air compressor and vacuum unit · Barrier Film; Handpiece Sleeves; Instrument Tray Sleeves; Light/Sensor Sleeves/Pouches; Barrier Sleeves; Syringe Sleeves · Dental Tray Cover, Headrest Cover, Intraoral Camera Sheath | — | — |
| Midwest Dental | United States | Repacker / relabeler | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | sleeves | — | — |
| Palmero Healthcare | United States | Repacker / relabeler | Vacuum Clean · Vacuum Shock | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | UNIT, OPERATIVE DENTAL, ACCESSORIES | — | — |
| Atlas Healthcare LLC | United States | Repacker / relabeler | SomaGuard Self-Adhesive Barrier Film | — | — |
| BGSS Company Inc. | United States | Repacker / relabeler | TRAY COVER | — | — |
| PacStar International, inc. | United States | Repacker / relabeler | SLEEVES, BARRIER FILM | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 20 Dec 2007 | K072273 | BELMONT QUOLIS 5000 SERIES DENTAL UNIT | Takara Belmont USA, Inc. |
| 31 Aug 2004 | K042266 | ACCLAIM | Duerr Dental SE |
Official records: FDA product classification for NRD · 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