Data / Medical devices / Bracket, Metal, Orthodontic

Bracket, Metal, Orthodontic (EJF): 119 FDA-registered makers in 20 countries

Name: FDA-registered makers of Bracket, Metal, Orthodontic
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

119 establishments in 20 countries are registered with the FDA to make Bracket, Metal, Orthodontic (product code EJF, Class 1, 21 CFR 872.5410). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 103 510(k) clearances under this code, the latest on March 14, 2000, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code: EJF
Device class: 1
Regulation: 872.5410
Medical specialty: Dental

Makers by country

Country	Makers
China	50
United States	28
South Korea	7
Germany	6
Mexico	6
Brazil	4
India	2
Canada	2
Italy	2
Taiwan	2
Philippines	1
Vietnam	1
Austria	1
Hong Kong	1
Sweden	1
Singapore	1
Pakistan	1
Switzerland	1
Poland	1
Japan	1

Makers of Bracket, Metal, Orthodontic

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	Recall events	Source
American Orthodontics	Sheboygan, WI, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	2	July 30, 1992	0	api.fda.gov
Azure Microdynamics, Inc.	Foothill Ranch, CA, United States	Manufacturer	1	January 26, 1994	0	api.fda.gov
CDB Corporation	Leland, NC, United States	Manufacturer, Repackager or relabeler	1	July 30, 1992	0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	1	February 4, 1994	0	api.fda.gov
G & H Wire Company	Franklin, IN, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler	1	July 30, 1992	0	api.fda.gov
Modern Orthodontics	Ludhiana, Punjab, India	Manufacturer	1	July 30, 1992	0	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	1	July 30, 1992	1	api.fda.gov
Ortho-Cycle Co.	Hollywood, FL, United States	Reprocessor	1	November 27, 1991	0	api.fda.gov
Acme-Monaco Corp.	New Britain, CT, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Acme-Monaco Corp.	Presque Isle, ME, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Aditek Do Brasil, SA	CRAVINHOS Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Aso International Manila, Inc.	Cavite,Region IVa,, Philippines	Manufacturer	0		0	api.fda.gov
Astar Orthodontics Inc.	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Allesee Orthodontic Appliances, Inc.	Sturtevant, WI, United States	Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG	Bremen, Germany	Manufacturer	0		0	api.fda.gov
Beijing Smart Technology Co., Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Boch Group LLC	Burlington, CT, United States	Specification developer	0		0	api.fda.gov
Calibaja Manufacturing, S.A. De C.V.	MEXICALI Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Changsha Nice Medical Instrument Limited Company	Changsha Hunan, China	Manufacturer	0		0	api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.	Chengdu Sichuan, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Cometech VN Company Limited	Phu Thanh Ward Ho Chi Minh, Vietnam	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer, Repackager or relabeler	0		0	api.fda.gov
Celebrace	Colleyville, TX, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.	Changsha Hunan, China	Manufacturer	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	api.fda.gov
Dental Morelli Ltda.	SOROCABA Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Dentos, Incorporated	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
Dickerson Orthodontics	Phoenix, AZ, United States	Manufacturer	0		0	api.fda.gov
Dongguan Wanjin Industrial Co., Ltd	DongGuang Guangdong, China	Remanufacturer	0		0	api.fda.gov
DW Lingual Systems GmbH	Bad Essen Lower Saxony, Germany	Manufacturer	0		0	api.fda.gov
E. Tec SA De C.V.	Tijuana Baja California, Mexico	Remanufacturer	0		0	api.fda.gov
EC Certification Service GmbH	St. Veit/Glan Karnten, Austria	Manufacturer	0		0	api.fda.gov
F-Six Dental Technology Co.,limited	Central Hong Kong, Hong Kong	Exporter to the US, Manufacturer	0		0	api.fda.gov
Foo Tian Dental Laboratory	Shenzhen Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Fseven Dental Technology Zhuhai Co.,ltd	ZHUHAI Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Funing Meitedental Factory	Yancheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
GARNET DENTECH Corp	Daegu, South Korea	Manufacturer	0		0	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Gestenco International AB	GOTEBORG Vastra Gotaland, Sweden	Complaint file establishment, Manufacturer	0		0	api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Guangzhou Cheer-U Material Technology Co., Ltd	Guangzhou Guangdong, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Guangzhou Oo Medical Scientific Limited	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Guangzhou Riton Biomaterial Co., Ltd	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
GZ Chuangqi Medical Tech Co., Ltd.	Guangzhou Guangdong, China	Manufacturer	0		0	api.fda.gov
Great Lakes Dental Technologies, Ltd.	Tonawanda, NY, United States	Manufacturer	0		0	api.fda.gov
Guangzhou Four E's Scientific Co., Ltd.	GUANGZHOU Guangdong, China	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou DTC Medical Apparatus Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Orthmay Advanced Materials Technology Co., Ltd	Hangzhou City Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hangzhou Pengwu Medical Equipment Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Hangzhou Westlake Biomaterial Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hespeler Orthodontics Limited	CAMBRIDGE Ontario, Canada	Manufacturer	0		0	api.fda.gov
HT Co., Ltd.	Yongin-si Gyeonggi, South Korea	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Hansfive (Hangzhou) Dental Technology Co.,Ltd	Hangzhou city Zhejiang, China	Manufacturer	0		0	api.fda.gov
Improve Co.,limited	Lantau Island Hong Kong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Innobrace Orthodontics Pte Ltd	SINGAPORE Central Singapore, Singapore	Manufacturer	0		0	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jiangsu Province Yangzhou Shuguang Toothbrush Manufactory	YANG ZHOU Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jinhua Glamb Medical Equipment Co.,ltd	Jinhua City Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Jiscop Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer	0		0	api.fda.gov
Libral Traders Pvt. Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Lohar Medical Company	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Lorelli Technologies LLC	Fountain Valley, CA, United States	Manufacturer	0		0	api.fda.gov
LightForce Orthodontics	Wilmington, MA, United States	Manufacturer	0		0	api.fda.gov
Medartis AG	BASEL Basel-Stadt, Switzerland	Manufacturer	0		0	api.fda.gov
Mem Dental Technology Co Ltd	Tainan, Taiwan	Manufacturer	0		0	api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.	Ningbo City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Orthguide Medical Technology (jiangsu) Co., Ltd	Wuxi City Jiangsu, China	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho Attachyhook Supply Ltd.	Anmore British Columbia, Canada	Exporter to the US, Foreign private label distributor, Specification developer	0		0	api.fda.gov
Orthodontic Manufacturer Sia SRL	ROCCA D EVANDRO Caserta, Italy	Manufacturer	0		0	api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.	Marilia Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
Ortotec De BC MX SA De CV	Tecate Baja California, Mexico	Contract manufacturer, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
OSSTEM ORTHODONTICS Inc.	Uiwang-si Gyeonggi, South Korea	Manufacturer, Specification developer	0		0	api.fda.gov
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	0		0	api.fda.gov
Ortho Traction Pads	Norwalk, CT, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
PSM Medical GmbH	Gunningen Baden-Wurttemberg, Germany	Complaint file establishment, Specification developer	0		0	api.fda.gov
Progressive Orthodontics USA	Aliso Viejo, CA, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
Rmo	Franklin, IN, United States	Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, Mexico	Contract manufacturer	0		0	api.fda.gov
Shenzhen Bairunheng Technology Co., Ltd.	shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Sino Ortho Limited	HANGZHOU Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sunstar Trading International Limited	Kowloon Hong Kong, China	Manufacturer	0		0	api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	Manufacturer	0		0	api.fda.gov
Solventum Germany GmbH	Kamen North Rhine-Westphalia, Germany	Manufacturer	0		0	api.fda.gov
Solventum Orthodontics Corporation	Monrovia, CA, United States	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	0		0	api.fda.gov
Solventum Poland Manufacturing SP. ZO.O	Wroclaw Dolnoslaskie, Poland	Manufacturer	0		0	api.fda.gov
Solventum US LLC	Irvine, CA, United States	Contract manufacturer	0		0	api.fda.gov
Tecnident Equipamentos Ortodonticos Ltda.	SAO CARLOS Sao Paulo, Brazil	Exporter to the US, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Tomy, Inc.	Iwaki City Fukushima, Japan	Manufacturer	0		0	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	0		0	api.fda.gov
Tribest Dental Products Co Ltd	Yangzhong Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
The American Angle, LLC	Brooklyn, NY, United States	Contract manufacturer, Specification developer	0		0	api.fda.gov
United Dental Changzhou	Changzhou Jiangsu, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Univy Technology Advanced Co. Ltd	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
World Bio Tech Co Ltd	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
World Class Technology Corporation	Mcminnville, OR, United States	Manufacturer	0		0	api.fda.gov
Wuhu Guli Ortho Co.,ltd	Wuhu Anhui, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Wuxi TP Orthodontics Material Co., Ltd.	WUXI Jiangsu, China	Manufacturer	0		0	api.fda.gov
Xemax Surgical Products, Inc.	Napa, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0		0	api.fda.gov
Yancheng Denrum Medical Apparatus Co.,ltd.	Yancheng Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Ze Fang Technology Co., Ltd.	Taichung, Taiwan	Manufacturer	0		0	api.fda.gov
Zhejiang Eksen Medical Technology Co., Ltd	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Zhejiang Headway Medical Equipment Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.	Anji Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Risheng Medical Technology Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.	Yang Jiao Lang Zin'an Town Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Yo Medical Technology Co., Ltd	Huzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Shinye Medical Technology Corp.,Ltd	HANGZHOU Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Yahong Medical Apparatus Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	0		0	api.fda.gov

Updated March 14, 2000. 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.