Data / Medical devices / Unit, Syringe, Air And/Or Water
Unit, Syringe, Air And/Or Water (ECB): 102 FDA-registered makers in 13 countries
102 establishments in 13 countries are registered with the FDA to make Unit, Syringe, Air And/Or Water (product code ECB, Class 1, 21 CFR 872.4565). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on August 23, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ECB
- Device class
- 1
- Regulation
- 872.4565
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| China | 51 |
| United States | 20 |
| Germany | 7 |
| Hong Kong | 6 |
| Italy | 4 |
| France | 2 |
| Canada | 2 |
| Brazil | 2 |
| South Korea | 2 |
| India | 2 |
| Pakistan | 2 |
| Israel | 1 |
| Taiwan | 1 |
Makers of Unit, Syringe, Air And/Or Water
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A-dec, Inc. | Newberg, OR, United States | Manufacturer, Repackager or relabeler | 1 | November 29, 1993 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Manufacturer, Specification developer | 1 | May 3, 1992 | 0 | 0 | 0 | api.fda.gov |
| A. Schweickhardt GMBH & Co. KG | Seitingen-Oberflacht Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accs Products, Inc. | Lake Zurich, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acteon Manufacturing | Merignac Gironde, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AMD Medicom Inc. | Pointe-Claire, Montreal Quebec, Canada | Complaint file establishment, Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angelus Industria De Productos Odontologicos | LONDRINA Parana, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Ares Medical Technology Co.,ltd. | Tianchang Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anqing Clean Dental Instrument Technology Co.,ltd | Anqing City Anhui, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Artiglass SRL | Due Carrare Padova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ATRIA Co. | Seoul, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Alliage S/A Industrias Medico Odontologica | Ribeirao Preto Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beaverstate Dental, Inc. | Newberg, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BGSS Company Asia Limited | Zhabei Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BH Medical Products Co., Ltd | Changzhou City Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boen Healthcare Co., Ltd. | Suzhou Jiangsu, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Busse Hospital Disposables | Hauppauge, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou Hebei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDM Center Of Excellence Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Shengkang Medical Instrument Co.,ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changzhou Yingfang E-Commerce Co., Ltd | Changzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Crosstex International | Rush, NY, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DCI International, LLC | Newberg, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Debo Medical Technology (shijiazhuang) Co., Ltd. | Shijiazhuang Hebei, China | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentalmaster (xiamen) Medical Technology Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Devemed GMBH | NEUHAUSEN OB ECK Baden-Wurttemberg, Germany | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dewimed Medizintechnik GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Ouwen Medical Device Technology Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Yilong Medical Supplies Co.. Ltd. | Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroband Bioline LTD. | INDUSTRIAL PARK EMEK HEFER Central, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Faro S.P.A. | Ornago (MB) Milano, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FDC Technology Industry Company | Taishan,GUANG CHONG Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Foshan Zike Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gorgeous Beauty Equipment Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Xinuo Personal Care Products Co., Ltd | Yunfu City Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager Worldwide, Inc. | Hickory, NC, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Biotechnology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Mita Technology Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hebei Tuosite Technology Co.,ltd | Shijiazhuang Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Jingcheng Plastic Products Co. Ltd | Hefei Anhui, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Helmut Zepf Medizintechnik GMBH | SEITINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua DK Dental Co., Ltd | HuangHua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Huanghua Promisee Dental Co., Ltd | Huanghua Hebei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Guarddent Medical Technology Co.,ltd | Wuhan Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd | Qianjiang, Hubei, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hefei Xingcheng Sanitary Products CO.,LTD | Hefei Anhui, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Henan Lusterdent Medical Instrument Co.,Ltd | Zhengzhou Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Indo-German Surgical Corporation | Mumbai Maharashtra, India | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inter-Med, Inc. | Racine, WI, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intersurgical S.P.A. | Mirandola (MO) Italy Modena, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra LifeSciences Production Corporation | Mansfield, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Dynamic Medical Technology Co., Ltd | Suzhou Jiangsu, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangyin Nanquan Macromolecule Product Co., Ltd. | JIANGYIN Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kdans Surgical Private Limited | GANDHINAGAR Gujarat, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lakong Medical Devices Co., Ltd. | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Luzzani Dental SRL | Senago Milano, Italy | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medcave Private Limited | Sialkot Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Devices Group Limited | N.T., Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nucare LLC | Montclair, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oman Medical Beauty Manufacture Limited | Hong Kong, Hong Kong | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osung MND Co., Ltd. | Gimpo-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pacific Care Limited / Pacificare Asia Limited | Hong Kong, Hong Kong | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Palmero Healthcare LLC | Northbrook, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Panorama International. | SIALKOT Punjab, Pakistan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parts Warehouse Inc | Lynden, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plasdent Shanghai Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Plastic Billat | GAMACHES Somme, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premium Plus (dongguan) Limited | Dongguan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pro-Med Instrumente GMBH | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rolence Ent. Inc. | CHUNGLI Taoyuan, Taiwan | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sable Industries, Inc. | Kitchener Ontario, Canada | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Alwings Medical Instrument Co.,ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Lions Industrial Co.,ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shurcon Manufacturing Company | Jia Shan Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Joy Crown Industry Co., Ltd | Pu Dong New Area Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Senlede Technologies Co., Ltd | Shenzhen Guangdong, China | Contract manufacturer, Exporter to the US | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Pac-Dent Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd. | Tianjin, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tianjin Water Source Tech Co., Ltd. | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tidi Products, LLC | Neenah, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ustomed Instrumente GMBH & Co. KG | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellmed Dental Medical Supply Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiantao S&J Protective Products Co., Ltd | Xiantao Hubei, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yiwu Jiekang Medical Articles Co., Ltd. | Yiwu, Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Dental Manufacturing Co 1, LLC. | Earth City, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Innovations Inc. | Algonquin, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Young Microbrush LLC | Grafton, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yueying Medical Instruments (langfang) Co., Ltd. | Langfang City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yongqing Huaguan Dental Instruments Factory | Langfang City Hebei, China | Contract manufacturer, Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Mediunion Healthcare Group Co.,ltd | Ningbo Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin'an Town Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZOGEAR Medical Co., Ltd. | Yizheng Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iBrite Suzhou Technology Co., Ltd | SUZHOU CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 23, 1994. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.