Data / Medical devices / Positioner, Tooth, Preformed / China

FDA-registered makers of Positioner, Tooth, Preformed in China: 19 establishments

Name: FDA-registered makers of Positioner, Tooth, Preformed in China
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

19 establishments in China are registered with the FDA to make Positioner, Tooth, Preformed (product code KMY). 1 has a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device: Positioner, Tooth, Preformed
Product code: KMY
Country: China

Makers of Positioner, Tooth, Preformed in China

Maker	Location	Role	510(k) clearances	Latest clearance	Source
Wuxi TP Orthodontics Material Co., Ltd.	WUXI Jiangsu, China	Manufacturer	1	June 28, 1978	api.fda.gov
Aidite (qinhuangdao) Technology Co., Ltd	Qinhuangdao City Hebei, China	Manufacturer	0		api.fda.gov
Dongguan Yiyao Science & Technology Development Co., Ltd.	Dongguan City Guangdong, China	Manufacturer	0		api.fda.gov
Guangzhou Heygears Imc.inc	Guangzhou Guangdong, China	Specification developer	0		api.fda.gov
Hangzhou Shining3d Dental Technology Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Hantech Medical Device Co., Ltd.	Cixi Zhejiang, China	Manufacturer	0		api.fda.gov
Hubei Yjt Intelligent Technology Group Co., Ltd.	Wuhan Hubei, China	Manufacturer	0		api.fda.gov
Huizhou Gold Rose Technology Co.,ltd	huizhou Guangdong, China	Complaint file establishment, Contract manufacturer, Exporter to the US, Foreign private label distributor, Repackager or relabeler, Specification developer	0		api.fda.gov
Jiangxi Heygears Innovative Material Co., Ltd	Jiujiang Jiangxi, China	Contract manufacturer	0		api.fda.gov
Nanchang White Technology Co., Ltd.	Nanchang Jiangxi, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Ningbo Sezen Technology Co., Ltd.	Ningbo Zhejiang, China	Contract manufacturer	0		api.fda.gov
Riton 3D Technology Co., Ltd	Guangzhou Guangdong, China	Manufacturer	0		api.fda.gov
Royal Dental Lab	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Shanghai Lions Industrial Co.,ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Shenzhen Sunmc Dental Technology Co., Ltd.	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.	Yang Jiao Lang Zin'an Town Zhejiang, China	Manufacturer	0		api.fda.gov
Zhejiang Yinchili Medical Technology Co.,ltd	Jiaxing City Zhejiang, China	Contract manufacturer, Manufacturer	0		api.fda.gov

Updated November 2, 2026. 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.