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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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
ECB
Device class
1
Regulation
872.4565
Medical specialty
Dental

Makers by country

CountryMakers
China51
United States20
Germany7
Hong Kong6
Italy4
France2
Canada2
Brazil2
South Korea2
India2
Pakistan2
Israel1
Taiwan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
A-dec, Inc.Newberg, OR, United StatesManufacturer, Repackager or relabeler1November 29, 1993000api.fda.gov
Dentsply LLCYork, PA, United StatesManufacturer, Specification developer1May 3, 1992000api.fda.gov
A. Schweickhardt GMBH & Co. KGSeitingen-Oberflacht Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Accs Products, Inc.Lake Zurich, IL, United StatesManufacturer0000api.fda.gov
Acteon ManufacturingMerignac Gironde, FranceSpecification developer0000api.fda.gov
AMD Medicom Inc.Pointe-Claire, Montreal Quebec, CanadaComplaint file establishment, Exporter to the US, Specification developer0000api.fda.gov
Angelus Industria De Productos OdontologicosLONDRINA Parana, BrazilManufacturer0000api.fda.gov
Anhui Ares Medical Technology Co.,ltd.Tianchang Anhui, ChinaManufacturer0000api.fda.gov
Anqing Clean Dental Instrument Technology Co.,ltdAnqing City Anhui, ChinaExporter to the US, Manufacturer0000api.fda.gov
Artiglass SRLDue Carrare Padova, ItalyManufacturer0000api.fda.gov
ATRIA Co.Seoul, South KoreaManufacturer0000api.fda.gov
Alliage S/A Industrias Medico OdontologicaRibeirao Preto Sao Paulo, BrazilManufacturer0000api.fda.gov
Beaverstate Dental, Inc.Newberg, OR, United StatesManufacturer0000api.fda.gov
BGSS Company Asia LimitedZhabei Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
BH Medical Products Co., LtdChangzhou City Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Boen Healthcare Co., Ltd.Suzhou Jiangsu, ChinaExporter to the US, Specification developer0000api.fda.gov
Busse Hospital DisposablesHauppauge, NY, United StatesManufacturer0000api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.Cangzhou Hebei, ChinaExporter to the US, Manufacturer0000api.fda.gov
CDM Center Of Excellence Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Changzhou Shengkang Medical Instrument Co.,ltdChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Changzhou Yingfang E-Commerce Co., LtdChangzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Crosstex InternationalRush, NY, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
DCI International, LLCNewberg, OR, United StatesManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dentalmaster (xiamen) Medical Technology Co., Ltd.Xiamen Fujian, ChinaManufacturer0000api.fda.gov
Devemed GMBHNEUHAUSEN OB ECK Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Dewimed Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Dongguan Ouwen Medical Device Technology Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Dongguan Yilong Medical Supplies Co.. Ltd.Dongguan Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Dentsply Sirona Orthodontics Inc.Sarasota, FL, United StatesContract manufacturer0000api.fda.gov
Euroband Bioline LTD.INDUSTRIAL PARK EMEK HEFER Central, IsraelSpecification developer0000api.fda.gov
Faro S.P.A.Ornago (MB) Milano, ItalyManufacturer0000api.fda.gov
FDC Technology Industry CompanyTaishan,GUANG CHONG Guangdong, ChinaManufacturer0000api.fda.gov
Foshan Zike Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Gorgeous Beauty Equipment Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.Foshan Guangdong, ChinaManufacturer0000api.fda.gov
Guangdong Xinuo Personal Care Products Co., LtdYunfu City Guangdong, ChinaManufacturer0000api.fda.gov
Hager Worldwide, Inc.Hickory, NC, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Hebei Mita Biotechnology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Mita Technology LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Hebei Tuosite Technology Co.,ltdShijiazhuang Hebei, ChinaManufacturer0000api.fda.gov
Hefei Jingcheng Plastic Products Co. LtdHefei Anhui, ChinaManufacturer0000api.fda.gov
Helmut Zepf Medizintechnik GMBHSEITINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Huanghua DK Dental Co., LtdHuangHua Hebei, ChinaManufacturer0000api.fda.gov
Huanghua Promisee Dental Co., LtdHuanghua Hebei, ChinaManufacturer0000api.fda.gov
Hubei Guarddent Medical Technology Co.,ltdWuhan Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hubei Qianjiang Kingphar Medical Material Co., LtdQianjiang, Hubei, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hefei Xingcheng Sanitary Products CO.,LTDHefei Anhui, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Henan Lusterdent Medical Instrument Co.,LtdZhengzhou Henan, ChinaManufacturer0000api.fda.gov
Indo-German Surgical CorporationMumbai Maharashtra, IndiaExporter to the US, Manufacturer0000api.fda.gov
Inter-Med, Inc.Racine, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Intersurgical S.P.A.Mirandola (MO) Italy Modena, ItalyManufacturer0000api.fda.gov
Integra LifeSciences Production CorporationMansfield, MA, United StatesSpecification developer0000api.fda.gov
Jiangsu Dynamic Medical Technology Co., LtdSuzhou Jiangsu, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jiangyin Nanquan Macromolecule Product Co., Ltd.JIANGYIN Jiangsu, ChinaManufacturer0000api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltdTianjin, ChinaManufacturer0000api.fda.gov
Kavo Dental GMBHWARTHAUSEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Kdans Surgical Private LimitedGANDHINAGAR Gujarat, IndiaContract manufacturer0000api.fda.gov
Kerr CorporationPomona, CA, United StatesReprocessor0000api.fda.gov
Lakong Medical Devices Co., Ltd.Dongguan Guangdong, ChinaManufacturer0000api.fda.gov
Luzzani Dental SRLSenago Milano, ItalyComplaint file establishment, Manufacturer0000api.fda.gov
Medcave Private LimitedSialkot Punjab, PakistanManufacturer0000api.fda.gov
Medical Devices Group LimitedN.T., Hong KongContract manufacturer0000api.fda.gov
Nucare LLCMontclair, CA, United StatesSpecification developer0000api.fda.gov
Oman Medical Beauty Manufacture LimitedHong Kong, Hong KongManufacturer0000api.fda.gov
Osung MND Co., Ltd.Gimpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Pacific Care Limited / Pacificare Asia LimitedHong Kong, Hong KongContract manufacturer0000api.fda.gov
Palmero Healthcare LLCNorthbrook, IL, United StatesSpecification developer0000api.fda.gov
Panorama International.SIALKOT Punjab, PakistanManufacturer0000api.fda.gov
Parts Warehouse IncLynden, WA, United StatesManufacturer0000api.fda.gov
Plasdent Shanghai Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Plastic BillatGAMACHES Somme, FranceContract manufacturer0000api.fda.gov
Premium Plus (dongguan) LimitedDongguan Guangdong, ChinaManufacturer0000api.fda.gov
Pro-Med Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rolence Ent. Inc.CHUNGLI Taoyuan, TaiwanExporter to the US, Manufacturer0000api.fda.gov
Sable Industries, Inc.Kitchener Ontario, CanadaContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Shanghai Lions Industrial Co.,ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shurcon Manufacturing CompanyJia Shan Zhejiang, ChinaManufacturer0000api.fda.gov
Sino-Vista Dental Instruments Co., Ltd.Zibo Shandong, ChinaContract manufacturer0000api.fda.gov
Shanghai Jolly Industrial Co., Ltd.Shanghai, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Shanghai Joy Crown Industry Co., LtdPu Dong New Area Shanghai, ChinaContract manufacturer0000api.fda.gov
Shenzhen Senlede Technologies Co., LtdShenzhen Guangdong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Suzhou Pac-Dent Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tianjin Jieyaxin Medical Plastic Equipment Co., Ltd.Tianjin, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Tianjin Water Source Tech Co., Ltd.Tianjin, ChinaManufacturer0000api.fda.gov
Tidi Products, LLCNeenah, WI, United StatesManufacturer0000api.fda.gov
Ustomed Instrumente GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Wellmed Dental Medical Supply Co., LtdShenzhen Guangdong, ChinaManufacturer0000api.fda.gov
Xiantao S&J Protective Products Co., LtdXiantao Hubei, ChinaManufacturer0000api.fda.gov
Yiwu Jiekang Medical Articles Co., Ltd.Yiwu, Zhejiang, ChinaManufacturer0000api.fda.gov
Young Dental Manufacturing Co 1, LLC.Earth City, MO, United StatesContract manufacturer0000api.fda.gov
Young Innovations Inc.Algonquin, IL, United StatesSpecification developer0000api.fda.gov
Young Microbrush LLCGrafton, WI, United StatesContract manufacturer0000api.fda.gov
Yueying Medical Instruments (langfang) Co., Ltd.Langfang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Yongqing Huaguan Dental Instruments FactoryLangfang City Hebei, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltdNingbo Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov
ZOGEAR Medical Co., Ltd.Yizheng Jiangsu, ChinaManufacturer0000api.fda.gov
iBrite Suzhou Technology Co., LtdSUZHOU CITY Jiangsu, ChinaContract manufacturer0000api.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.