Data / Medical devices / Unit, Operative Dental, Accessories

Unit, Operative Dental, Accessories (NRD): 112 FDA-registered makers in 14 countries

Name: FDA-registered makers of Unit, Operative Dental, Accessories
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

112 establishments in 14 countries are registered with the FDA to make Unit, Operative Dental, Accessories (product code NRD, Class 1, 21 CFR 872.6640). 2 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 2 510(k) clearances under this code, the latest on December 20, 2007, 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.

Get every maker of this device Makers in China Watch this device

Product code: NRD
Device class: 1
Regulation: 872.6640
Medical specialty: Dental

Makers by country

Country	Makers
China	63
United States	22
Taiwan	7
South Korea	5
Germany	4
Japan	2
Canada	2
Malaysia	1
Sweden	1
India	1
Italy	1
Hong Kong	1
France	1
Pakistan	1

Makers of Unit, Operative Dental, Accessories

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	Source
Takara Belmont Corporation	Osaka, Japan	Complaint file establishment, Specification developer	1	December 20, 2007	api.fda.gov
Takara Belmont Corporation, Osaka Factory	Osaka, Japan	Complaint file establishment, Manufacturer	1	December 20, 2007	api.fda.gov
A-dec, Inc.	Newberg, OR, United States	Manufacturer	0		api.fda.gov
Accs Products, Inc.	Lake Zurich, IL, United States	Manufacturer	0		api.fda.gov
Acme Tooling Technology Co., Ltd.	Fuxing Township Changhua, Taiwan	Contract manufacturer, Manufacturer	0		api.fda.gov
Adm Tronics Unltd, Inc.	Northvale, NJ, United States	Contract manufacturer	0		api.fda.gov
Aiobio Co., Ltd.	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		api.fda.gov
Air Techniques, Inc.	Melville, NY, United States	Manufacturer, Specification developer	0		api.fda.gov
Anhui JM Healthcare Products Co.,ltd.	Shouxian Anhui, China	Exporter to the US, Manufacturer	0		api.fda.gov
Apoza Enterprise Co., Ltd.	Hsin-Chuang District New Taipei, Taiwan	Manufacturer	0		api.fda.gov
Ari Medical Technology Co., Ltd.	Hefei Anhui, China	Manufacturer	0		api.fda.gov
ATRIA Co.	Seoul, South Korea	Manufacturer	0		api.fda.gov
Beyes Dental Inc	Toronto Ontario, Canada	Manufacturer	0		api.fda.gov
BGSS Company Asia Limited	Zhabei Shanghai, China	Exporter to the US, Manufacturer	0		api.fda.gov
BH Medical Products Co., Ltd	Changzhou City Jiangsu, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Cangzhou Lankang Medical Instruments Developing Co., Ltd.	Cangzhou Hebei, China	Exporter to the US, Manufacturer	0		api.fda.gov
CDM Center Of Excellence Ltd.	Beijing, China	Manufacturer	0		api.fda.gov
Chuan Fu Medical Instrument Co., Ltd	Taoyuan City, Taiwan	Manufacturer	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		api.fda.gov
Denjoy Dental Co., Ltd	Changsha city Hunan, China	Manufacturer	0		api.fda.gov
Dentalez Of Alabama	Bay Minette, AL, United States	Complaint file establishment, Manufacturer	0		api.fda.gov
Dhef Inc.	New Taipei City, Taiwan	Manufacturer	0		api.fda.gov
Dntlworks Equipment Corp.	Centennial, CO, United States	Manufacturer	0		api.fda.gov
Dome Inc	Tarzana, CA, United States	Manufacturer	0		api.fda.gov
Dongguan Magenta Medical Equipment Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		api.fda.gov
Dongguan Wanjin Industrial Co., Ltd	DongGuang Guangdong, China	Manufacturer	0		api.fda.gov
Dukal LLC	Ronkonkoma, NY, United States	Complaint file establishment, Specification developer	0		api.fda.gov
Dunamis Dental Co., Ltd.	Gwangmyeong-si Gyeonggi, South Korea	Exporter to the US, Manufacturer	0		api.fda.gov
Durr Dental Se	Bietigheim-Bissingen Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer, Specification developer	0		api.fda.gov
Dacheng Huaguan Dental Instruments Co., Ltd	Langfang Hebei, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Durr Optronik GmbH & Co. KG	Gechingen Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Enercon Technologies	Gray, ME, United States	Contract manufacturer	0		api.fda.gov
FDC Technology Industry Company	Taishan,GUANG CHONG Guangdong, China	Manufacturer	0		api.fda.gov
Foshan Gladent Medical Instrument Co.,ltd.	Foshan Guangdong, China	Exporter to the US, Manufacturer	0		api.fda.gov
Fomed Industries Inc	Qian Jiang Hubei, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Greatcare 4u Sdn Bhd	Selangor Darul Ehsan, Malaysia	Manufacturer	0		api.fda.gov
Guangdong Jinme Medical Technology Co., Ltd.	Foshan Guangdong, China	Manufacturer	0		api.fda.gov
Guangxi Ehall Medical Technology Co.,ltd	Nanning Guangxi, China	Exporter to the US, Manufacturer	0		api.fda.gov
Guangzhou Ajax Medical Equipment Co Ltd	Guangzhou Guangdong, China	Manufacturer	0		api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.	Guilin Guangxi, China	Manufacturer	0		api.fda.gov
GUILIN YIKESHI Medical Device CO LTD	Guilin Guangxi, China	Manufacturer	0		api.fda.gov
Guangdong Xinuo Personal Care Products Co., Ltd	Yunfu City Guangdong, China	Manufacturer	0		api.fda.gov
Hefei Mlush Sanitary Products Co.,ltd	Hefei Anhui, China	Manufacturer	0		api.fda.gov
Hefei MT Medical Co.,ltd.	Hefei Anhui, China	Exporter to the US, Manufacturer	0		api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		api.fda.gov
Huanghua DK Dental Co., Ltd	HuangHua Hebei, China	Manufacturer	0		api.fda.gov
Huanghua Promisee Dental Co., Ltd	Huanghua Hebei, China	Manufacturer	0		api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		api.fda.gov
Huzhou Junda Industry Co., Ltd.	Anji Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Heaven Healthcare Co., Ltd.	Shaoxing Zhejiang, China	Manufacturer	0		api.fda.gov
Hefei Xingcheng Sanitary Products CO.,LTD	Hefei Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
I.c.lercher-Solutions GMBH	Stockach Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Jiangsu Dynamic Medical Technology Co., Ltd	Suzhou Jiangsu, China	Exporter to the US, Manufacturer	0		api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.	Zhangjiagang City Jiangsu, China	Exporter to the US, Manufacturer	0		api.fda.gov
Jiangsu Saikang Medical Equipment Co., Ltd	Zhangjiagang Jiangsu, China	Exporter to the US, Manufacturer	0		api.fda.gov
Jinyuan Medical Equipment(tianjin)co.,ltd	Tianjin, China	Manufacturer	0		api.fda.gov
Jiujiang Huada Medical Dressing Co., Ltd.	JIUJIANG Jiangxi, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Lakong Medical Devices Co., Ltd.	Dongguan Guangdong, China	Manufacturer	0		api.fda.gov
Mastercraft Dental Co. Of Texas	Midlothian, TX, United States	Manufacturer	0		api.fda.gov
MDX Co., Ltd.	Gangneung-si Gangwon, South Korea	Manufacturer	0		api.fda.gov
Medimaging Integrated Solution Inc.	Hsinchu Hsinchu(City), Taiwan	Manufacturer	0		api.fda.gov
Medipack Medical Packaging MFG. Co.	DONGGUAN CITY Guangdong, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Midmark Corporation	Versailles, OH, United States	Manufacturer	0		api.fda.gov
Minitube AB	TRANGSVIKEN Jamtland, Sweden	Manufacturer	0		api.fda.gov
Motion Dental Equipment Corporation	New Taipei City, Taiwan	Manufacturer	0		api.fda.gov
Mouthwatch, Inc.	Metuchen, NJ, United States	Specification developer	0		api.fda.gov
MPS Project	New Delhi, India	Manufacturer	0		api.fda.gov
Ningbo Yingmed Medical Instruments Co.,ltd.	Ningbo Zhejiang, China	Exporter to the US, Manufacturer	0		api.fda.gov
Nucare LLC	Montclair, CA, United States	Specification developer	0		api.fda.gov
Omnia SRL	FIDENZA Parma, Italy	Manufacturer	0		api.fda.gov
Perioview, LLC	Surprise, AZ, United States	Manufacturer	0		api.fda.gov
Plasdent Shanghai Co., Ltd.	Shanghai, China	Manufacturer	0		api.fda.gov
Practicon, Inc.	Greenville, NC, United States	Specification developer	0		api.fda.gov
Premium Plus (dongguan) Limited	Dongguan Guangdong, China	Manufacturer, Repackager or relabeler	0		api.fda.gov
Proedge Dental Products	Centennial, CO, United States	Contract manufacturer, Manufacturer, Specification developer	0		api.fda.gov
Premium Plus International Limited	Hong Kong, Hong Kong	Manufacturer	0		api.fda.gov
R.E. Morrison Equipment Inc	Mississauga Ontario, Canada	Manufacturer	0		api.fda.gov
Ready Set Import	Beverly Hills, CA, United States	Specification developer	0		api.fda.gov
Ritter Concept GMBH	Biberach Baden-Wurttemberg, Germany	Manufacturer	0		api.fda.gov
Shanghai Alwings Medical Instrument Co.,ltd.	Shanghai, China	Manufacturer	0		api.fda.gov
Shanghai Greeloy Industry Co., Ltd	Shanghai, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Shanghai Handy Medical Equipment Co., Ltd.	Shanghai, China	Manufacturer	0		api.fda.gov
Shanghai Lions Industrial Co.,ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Shengiho Enterprise Co., Ltd.	Taichung City, Taiwan	Manufacturer	0		api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Shenzhen Samo Technology Co.,limited	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Shurcon Manufacturing Company	Jia Shan Zhejiang, China	Manufacturer	0		api.fda.gov
Sopro	LA CIOTAT CEDEX Bouches-du-Rhone, France	Manufacturer	0		api.fda.gov
Sota Cloud Corporation	Orange, CA, United States	Manufacturer	0		api.fda.gov
Sota Precision Optics, Inc.	Orange, CA, United States	Specification developer	0		api.fda.gov
Stoma Ventures, LLC	Fort Pierce, FL, United States	Repackager or relabeler, Specification developer	0		api.fda.gov
Surgicrafts	Sialkot Punjab, Pakistan	Manufacturer	0		api.fda.gov
Surgident Co., Ltd.	Dong-gu Daegu, South Korea	Manufacturer	0		api.fda.gov
Shanghai Jolly Industrial Co., Ltd.	Shanghai, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Shenzhen Senlede Technologies Co., Ltd	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US	0		api.fda.gov
Suzhou Pac-Dent Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		api.fda.gov
Tangshan Zhengtong Exhibition Co., Ltd.	Tangshan Hebei, China	Manufacturer	0		api.fda.gov
Tech West Inc.	Fresno, CA, United States	Manufacturer	0		api.fda.gov
TF New Material Sci And Tec Co.,ltd	Huainan Anhui, China	Manufacturer	0		api.fda.gov
Tianjin Water Source Tech Co., Ltd.	Tianjin, China	Manufacturer	0		api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Exporter to the US, Manufacturer	0		api.fda.gov
Wolf X-Ray Corp	Battleboro, NC, United States	Specification developer	0		api.fda.gov
Wellmed Dental Medical Supply Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0		api.fda.gov
Xiantao S&J Protective Products Co., Ltd	Xiantao Hubei, China	Exporter to the US, Manufacturer	0		api.fda.gov
Yangzhou Star Oral Care Product Co., Ltd.	Yangzhou Jiangsu, China	Contract manufacturer, Manufacturer	0		api.fda.gov
Yiwu Jiekang Medical Articles Co., Ltd.	Yiwu, Zhejiang, China	Manufacturer	0		api.fda.gov
Yueying Medical Instruments (langfang) Co., Ltd.	Langfang City Hebei, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Yongqing Huaguan Dental Instruments Factory	Langfang City Hebei, China	Contract manufacturer, Exporter to the US, Manufacturer	0		api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltd	Ningbo Zhejiang, China	Contract manufacturer, 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
iBrite Suzhou Technology Co., Ltd	SUZHOU CITY Jiangsu, China	Contract manufacturer	0		api.fda.gov

Updated December 20, 2007. 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.