Surgical devices · 21 CFR 872 Subpart E
Air and/or Water Syringe Unit
FDA device type “Unit, Syringe, Air And/Or Water”.
- Companies listing it
- 13196 makers
- Brands and models
- 188
- 510(k) clearances
- 120 in five years
- FDA name
- Unit, Syringe, Air And/Or Water
510(k) clearances per year, 1976–2026
Companies that list ECB
131 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | FLASHTIPS · Sani-Tip | 148 | 2026 |
| Inter-Med, Inc. | United States | Maker | Air/Water Syringe Tips · EZ-Lock Adapter · Precision Irrigator · SYRINGE TIP COVER | 7 | 2026 |
| Young Innovations Inc | United States | Maker | Biofree Tip · Biofree Tip; Crystal Tip; Natures Tip; Starz Tipz · Crystal Tip · Natures Tip · +3 | 23 | 2025 |
| Guangdong JINME Medical Technology Co., Ltd. | China | Maker | Dental air compressor | 5 | 2026 |
| Firstar Dental Company | United States | Maker | — | 3 | 2026 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Alliage S/A Industrias Medico Odontologica | Brazil | Maker | SYNCRUS G4 | 3 | 2024 |
| Premium Plus (Dongguan) Limited | China | Maker | air-water syringe tips · greenline syringe tips | 2 | 2025 |
| Lakong Medical Devices Co., Ltd. | China | Maker | Air Water Syringes, Syringe Tips - Metal & Disposable | 2 | 2026 |
| A-dec, Inc. | United States | Maker | A-dec 200 Dental System - Syringe · A-dec Air/Water Syringe · A-dec Air/Water Syringe Tip | 68 | 2022 |
| KaVo Dental GmbH | Germany | Maker | 0.773000 - Multifunction LUX Syringe · 0.773010 - Multifunction LUX Syringe · 0.773500 - 3-Function Syringe · 0.773510 - 3-Function Syringe · +2 | 2 | 2021 |
| DCI International LLC | United States | Maker | Dental syringe and accessories | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Syringe Tip | 1 | 2026 |
| Pacific Care Limited | Hong Kong SAR China | Maker | Astek Innovations Ltd. / Medicom | 1 | 2025 |
| Jiangsu Dynamic Medical Technology Co., Ltd | China | Maker | Dental Syringe | 1 | 2023 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | KIDS TRIPLE SYRINGE - BLUE · KIDS TRIPLE SYRINGE - PINK | 11 | 2021 |
| Rolence Ent., Inc. | Taiwan | Maker | 3-way syringes | 5 | 2009 |
| Integra LifeSciences Corporation | United States | Maker | Miltex · Padgett | 2 | 2014 |
| Beaverstate Dental, Inc. | United States | Maker | 113-014 · 113-015 · 113-202 · 113-400 · +6 | 2 | 1995 |
| Sable Industries, Inc. | Canada | Maker | Air/Water Syringe | 2 | 2009 |
| Hager Worldwide, Inc. | United States | Maker | Access Tip · Dura-Syringe · Duration Tip · Uni-Sryinge · +1 | 2 | 2005 |
| Osung Mnd Co Ltd | South Korea | Maker | SAE-01 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Air-Water Syringe Tip · Air/Water Syringe Unit · Oral Cavity Suction Device | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Air water dental syringe tip · dental syringe cleanser | — | — |
| Shanghai Alwings Medical Instrument Co.,Ltd. | China | Maker | Air/Water Syringe Tip | — | — |
| Medcave Private Limited | Pakistan | Maker | Unit Syringe | — | — |
| SPS/Crosstex International | United States | Maker | Air/Water Syringe Tips · Patient's Choice Sparkle | — | — |
| Panorama International | Pakistan | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Air water syringe tip · Unit, syringe, air and/or water | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Air water syringe tip · UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | — | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Anqing Clean Dental Instrument Technology Co Ltd | China | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Hubei Guarddent Medical Technology Co.,Ltd | China | Maker | Air Water Syringe Tips | — | — |
| BH Medical Products Co., Ltd | China | Maker | Air/Water Syringe Tips | — | — |
| NuCare LLC | United States | Maker | Air Water Syringe Tip | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Mouth Expander/ Mouth props | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Saliva Ejector | — | — |
| AMD Medicom Inc | Canada | Maker | Hedy Air/Water Syringe Tip · Hedy Intra Oral Tips · Pro-Syringe · Pro-Tip Turbo Converter Adec · +4 | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Saliva Ejector | — | — |
| READY SET IMPORT dba Mynt Professional | United States | Maker | RSI Air/Water Syringe Tips | — | — |
| Hefei Xingcheng Sanitary Products CO.,LTD | China | Maker | Irrigation tip, Air water syringe tip | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip,Curved Utility Syringes, HP Mixing Tip | — | — |
| Henan Lusterdent Medical Instrument Co.,Ltd | China | Maker | Air Water Syringe Tips / Air Water Syringe Adapter Unit | — | — |
| CDM Center of Excellence Ltd. | China | Maker | Unit, Syringe, Air And/Or Water | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Disposable Air-Water Syringe Tips, Cover Of Air-Water Syringe Tips,Curved Utility Syringes, HP Mixing Tip | — | — |
| Boen Healthcare Co Ltd | China | Maker | Dental Irrigation Syringe | — | — |
| Xiantao S&J Protective Products Co., Ltd | China | Maker | Air/Water Syringe Tips, Curved Utility Syringes | — | — |
| Hubei Qianjiang Kingphar Medical Material Co Ltd | China | Maker | Air Water Syringe Tips | — | — |
| Tianjin Water Source Tech Co., Ltd. | China | Maker | Unit, Syringe, Air and/or Water-syringe covers, tip covers | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | UNIT, SYRINGE, AIR ANDIOR WATER | — | — |
| Plasdent Shanghai Co., Ltd. | China | Maker | Unit, Syringe, Air and/or Water-syringe covers, tip covers | — | — |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | Air-water syringe Tip | — | — |
| Wellmed Dental Medical Supply Co., Ltd. | China | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Palmero Healthcare | United States | Maker | Syringe Tip Cover | — | — |
| Zhejiang Mediunion Healthcare Group Co Ltd | China | Maker | Evergrand Glass Syringe,Water syring tips | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| Luzzani Dental srl | Italy | Maker | CGSMMGSG MINIMATE CG SYRINGE, ANGLED · CGSMMSSG MINIMATE CG SYRINGE, STRAIGHT · SB3SSG MINIBRIGHT SYRINGE 3F, STRAIGHT · SB6GSG MINIBRIGHT SYRINGE 3F, ANGLED · +8 | — | — |
| Yongqing Huaguan Dental Instruments Factory | China | Maker | Air/Water Syringe Tips | — | — |
| Hefei Jingcheng Plastic Products Co. Ltd | China | Maker | Syringe | — | — |
| Yueying Medical Instruments (Langfang) Co., Ltd. | China | Maker | Air/Water Syringe Tips | — | — |
| Anhui Ares Medical Technology Co.,Ltd. | China | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Changzhou Shengkang Medical Instrument Co.,LTD | China | Maker | Disposable dental irrigation needles | — | — |
| FARO S.p.A. | Italy | Maker | SYR 3 · SYR 6 | — | — |
| Dongguan Yilong Medical Supplies Co., Ltd. | China | Maker | Air-water Syringe Tips | — | — |
| Shurcon Manufacturing Company | China | Maker | ACCS UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Dongguan Ouwen Medical Device Technology Co., Ltd. | China | Maker | Disposable Air-Water Syringe Tips | — | — |
| Jiangyin Nanquan Macromolecule Product Co Ltd | China | Maker | Dental irrigation syringe | — | — |
| TianJin Jieyaxin Medical Plastic Equipment Co., Ltd. | China | Maker | Air/water syringe tip | — | — |
| Shanghai Joy Crown Industry Co., Ltd | China | Maker | JOY133 | — | — |
| Yiwu Jiekang Medical Articles Co., Ltd. | China | Maker | Syringe Sleeves, Syring Tip Cover | — | — |
| Acteon Manufacturing | France | Maker | Art by RISKONTROL · Classic by RISKONTROL · Total Protect by RISKONTROL | — | — |
| Plastic Billat | France | Maker | ART BY RISKONTROL · CLASSIC BY RISKONTROL · TOTAL PROTECT BY RISKONTROL | — | — |
| Accs Products, Inc. | United States | Maker | ACCS Syringe Air/Water | — | — |
| BGSS Company Asia Limited | China | Maker | — | — | — |
| Foshan Zike Technology Co., Ltd. | China | Maker | Air pressure suit:ZK-A01,ZK-A02,ZK-A03,ZK-A04,ZK-A05,ZK-A06,ZK-A07,ZK-A08,ZK-A09,ZK-A10,ZK-A11,ZK-A12,ZK-A13, · ZK-A14,ZK-A15,ZK-A16,ZK-A17,ZK-A18,ZK-A19,ZK-A20 | — | — |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong SAR China | Maker | Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03,OMD76,OM167, · OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 | — | — |
| Hebei Mita Biotechnology Limited | Hong Kong SAR China | Maker | Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149, · OMG150,OMG-PST001,D03,OMD76,OM167,OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 | — | — |
| Hebei Mita Technology Limited | Hong Kong SAR China | Maker | Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03, · OMD76,OM167,OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 | — | — |
| Oman Medical Beauty Manufacture Limited | Hong Kong SAR China | Maker | Air pressure suit:AGF64,OMG61,OMG145,ksh68,OMG146,OMG147,OMG148,OMG149,OMG150,OMG-PST001,D03,OMD76,OM167, · OMG-PST002,OMG-PST003,OMG-QYF0013,XOM-QYF001 | — | — |
| Parts Warehouse Inc | United States | Maker | Dental Syringe and Accessories | — | — |
| Changzhou Yingfang E-commerce Co., LTD | China | Maker | syringe | — | — |
| Euroband Bioline Ltd | Israel | Maker | Syringes, pre-filled, water or air | — | — |
| Hebei Tuosite Technology Co.,Ltd | China | Maker | Air pressure suit:BR604,BR610,BR611,BR618,BR615,BR619PRO | — | — |
| Indo-German Surgical Corporation | India | Maker | SILICONE BULB | — | — |
| Intersurgical S.p.A. | Italy | Maker | CP903 | — | — |
| Kdans Surgical Private Limited | India | Maker | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Robert Busse & Co., Inc. | United States | Maker | ALL PURPOSE BULB SYRINGE | — | — |
| USTOMED INSTRUMENTE GmbH & Co. KG | Germany | Maker | — | — | — |
| Artiglass S.r.l. | Italy | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| DEWIMED Medizintechnik GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Medical Devices Group Limited | Hong Kong SAR China | Maker | — | — | — |
| PRO-MED Instrumente GmbH | Germany | Maker | — | — | — |
| TIDI Products LLC | United States | Maker | — | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | ZenSeal Pro Syringe Barrel and Plunger | 203 | 2026 |
| Satelec - Acteon Group | United States | Manufacturer | Riskontrol | 18 | 2024 |
| Keystone Industries | United States | Contract manufacturer | Prehma Disposable Air/Water Syringe Tips | 2 | 2025 |
| Biomet Microfixation | United States | Manufacturer | CHIP BLOWER · SYRINGE | 8 | 2021 |
| Storz AM Mark GmbH | Germany | Contract manufacturer | Spare cannula for water syringe · Water syringe | 2 | 2008 |
| One Dashcorp | United States | Repacker / relabeler | Valdent USA 3-Way Autoclavable Air/Water Syringe, Standard with 2 Metal Tips · Valdent USA Disposable Air/Water Syringe Tips, White | — | — |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | AIR WATER SYRINGE · AIR WATER SYRINGE COVER · AIR WATER SYRINGE TIP | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | STAR5 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Tips | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | DISPOSABLE DENTAL SYRINGE, AIR/WATER SYRINGE TIPS | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Tips | — | — |
| Practicon, Inc. | United States | Manufacturer | Practicon Clear Disposable A/W Syringe Tips · Practicon Onyx Disposable A/W Syinge Tips · Practicon Rainbow Disposable A/W Syringe Tips · PractiTip A-W Syringe Tips | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Premium Plus Dental | United States | Lister | Premium Plius "a" Air Water Syringe Tips · Premium Plus Clear Air/Water Syringe Tips · Premium Plus e Air - Water Syringe Tips | — | — |
| Yizur Ltd | Hong Kong SAR China | Foreign exporter | Tips | — | — |
| CARGUS International Inc. | United States | Repacker / relabeler | MARK3 Air Water Tips | — | — |
| battech | United States | Repacker / relabeler | Air-Water Syringe Tip, Cover Of Air-Water Syringe Tip.Curved Utility Syringes, HP Mixing Tip | — | — |
| Shanghai smedent medical instrument co., ltd. | China | Foreign exporter | air water syringe tips plastic w/Metal core, metal air water syringe tips metal | — | — |
| Plasdent Corporation | United States | Repacker / relabeler | UNIT,SYRINGE,AIR AND/OR WATER-SYRINGE COVERS, TIP COVERS | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | Air Water Syringe | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | disposable dental Syringe, Air/Water Syringe tips | — | — |
| Dukal Corporation | United States | Specification developer | Unipack Air/Water Syringe Tips, including private label. | — | — |
| Midwest Dental | United States | Repacker / relabeler | — | — | — |
| Shanghai Hua EN Industrial Co. Ltd. | China | Foreign exporter | Airway Syringe | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| Tianjin Medicines & Health Products Imp. & Exp. Corp. | China | Foreign exporter | UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| VastMEd LLC | United States | Repacker / relabeler | VASTMED UNIT, SYRINGE, AIR AND/OR WATER | — | — |
| 3D Dental Designs and Development LLC | United States | Contract manufacturer | — | — | — |
| Bright Supply Inc | United States | Lister | — | — | — |
| MN Health Inc, | United States | Repacker / relabeler | — | — | — |
| Shanghai Medicines & Health Products Imp. & Exp. Co., Ltd. | China | Foreign exporter | — | — | — |
| Stephens Instruments | United States | Repacker / relabeler | Syringe Cannula | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 23 Aug 1994 | K942519 | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS | Bull Frog Mfg. Co. |
| 7 Mar 1994 | K931772 | SURETIP SYRINGE TIP COVER | Western M/D, Inc. |
| 29 Nov 1993 | K931137 | DENTAL SYRINGE TIP | A-dec, Inc. |
| 5 Apr 1993 | K923876 | RISKONTROL SINGLE USE | Riskontrol |
| 15 Sep 1992 | K923285 | PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE | Smith & Nephew, Inc. |
| 3 May 1992 | K920499 | SANI-TIP | Dw Industries, Inc. |
| 24 Oct 1991 | K911756 | POSTERIOR NASAL EPISTAXIS INSTRUMENTS | Richard Wolf Medical Instruments Corp. |
| 29 Mar 1989 | K890290 | BRACE (ORAFIX SPECIAL) | Norcliff Thayer, Inc. |
| 25 Sep 1986 | K863024 | SERINGA TRIPLICE S.L. | Sds Dental, Inc. |
| 6 Jan 1986 | K854699 | TUBING SYRING | Almore Intl., Inc. |
| 4 Aug 1980 | K801686 | SPACELINE THREE WAY SYRINGE | Pacific Dental Corp. |
| 4 Dec 1978 | K781594 | DENTAL WARM WATER IRRIGATING SYSTEM | Rama Corp. |
Official records: FDA product classification for ECB · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026