Data / Medical devices / Cleaner, Denture, Mechanical

Cleaner, Denture, Mechanical (JER): 22 FDA-registered makers in 5 countries

Name: FDA-registered makers of Cleaner, Denture, Mechanical
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

22 establishments in 5 countries are registered with the FDA to make Cleaner, Denture, Mechanical (product code JER, Class 1, 21 CFR 872.3530). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 14 510(k) clearances under this code, the latest on October 25, 1988, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: JER
Device class: 1
Regulation: 872.3530
Medical specialty: Dental

Makers by country

Country	Makers
China	12
United States	7
Canada	1
Japan	1
Germany	1

Makers of Cleaner, Denture, Mechanical

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	Source
Aoj Health Technology Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Braebon Medical Corp.	KANATA Ontario, Canada	Specification developer	api.fda.gov
Changsha Gomecy Electronics Co., Ltd.	Changsha Hunan, China	Manufacturer	api.fda.gov
Chemlink Laboratories, LLC.	Kennesaw, GA, United States	Contract manufacturer, Manufacturer	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	api.fda.gov
Diversified Chemical Products, Inc	Wilmington, DE, United States	Contract manufacturer	api.fda.gov
Dongguan Mingchuangyoushang Electronic Technology Co., Ltd	dongguan Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Dongguan Miqiang Technology Co., Ltd	Dongguan Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Isonic Inc.	Chicago, IL, United States	Repackager or relabeler, Specification developer	api.fda.gov
Kiyou Jochugiku	Kainan Wakayama, Japan	Contract manufacturer, Manufacturer	api.fda.gov
Lakong Medical Devices Co., Ltd.	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Medtech Products, Inc.	Tarrytown, NY, United States	Complaint file establishment, Specification developer	api.fda.gov
Premier Dental Products Co.	Plymouth Meeting, PA, United States	Complaint file establishment, Specification developer	api.fda.gov
Renfert GMBH	HILZINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Shenzhen Balinda Technology Co.,ltd	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Rainbow Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Yiguangnian Innovation Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Xiazhifeng Electronic Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Teamwork Packaging, Inc.	San Bernardino, CA, United States	Contract manufacturer	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Manufacturer	api.fda.gov
Unette Corporation	Randolph, NJ, United States	Contract manufacturer, Repackager or relabeler	api.fda.gov

Updated October 25, 1988. 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.