Data / Medical devices / Band, Elastic, Orthodontic

Band, Elastic, Orthodontic (ECI): 75 FDA-registered makers in 10 countries

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

75 establishments in 10 countries are registered with the FDA to make Band, Elastic, Orthodontic (product code ECI, Class 1, 21 CFR 872.5410). 2 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on April 20, 1998, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
China	33
United States	21
Brazil	4
Mexico	4
South Korea	4
Germany	2
Italy	2
India	2
Japan	2
Taiwan	1

Makers of Band, Elastic, 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
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	1	February 4, 1994	0	api.fda.gov
Ortho Kinetics Corp.	Vista, CA, United States	Manufacturer	1	April 20, 1998	0	api.fda.gov
Aditek Do Brasil, SA	CRAVINHOS Sao Paulo, Brazil	Manufacturer	0		0	api.fda.gov
American Orthodontics	Sheboygan, WI, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Astar Orthodontics Inc.	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Auradonics Incorporated	Riverside, NJ, United States	Manufacturer	0		0	api.fda.gov
Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG	Bremen, Germany	Manufacturer	0		0	api.fda.gov
Bioseal	Placentia, CA, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	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
Creative Dental	Jinhua City Zhejiang, 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
E. Tec SA De C.V.	Tijuana Baja California, Mexico	Remanufacturer	0		0	api.fda.gov
Eagle Mold Technologies, Inc.	Poway, CA, United States	Contract manufacturer	0		0	api.fda.gov
Funing Meitedental Factory	Yancheng Jiangsu, China	Manufacturer	0		0	api.fda.gov
G & H Wire Company	Franklin, IN, United States	Manufacturer, Repackager or relabeler	0		2	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	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
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	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 Xingchen 3B Dental Instrument & Materials Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0		0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Huanghua DK Dental Co., Ltd	HuangHua Hebei, China	Manufacturer	0		0	api.fda.gov
Hubei Guarddent Medical Technology Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Icp, Inc.	Green Bay, WI, United States	Specification developer	0		0	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi 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, Specification developer	0		0	api.fda.gov
Libral Traders Pvt. Ltd.	New Delhi, India	Manufacturer	0		0	api.fda.gov
Mem Dental Technology Co Ltd	Tainan, Taiwan	Manufacturer	0		0	api.fda.gov
Modern Orthodontics	Ludhiana, Punjab, India	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
O&S Dental, Inc.	Chicago, IL, United States	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 Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, 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
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Manufacturer	0		0	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	0		0	api.fda.gov
Ortho Solutions LC	Lake Saint Louis, MO, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Polymer Engineering Laboratories Ltd.	Iwamizawa Hokkaido, Japan	Manufacturer	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
Shanghai Dochem Industries Co., Ltd.	Shanghai, 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
Snapz Innovations Inc	Plantation, FL, United States	Specification developer	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 Orthodontics Corporation	Monrovia, CA, United States	Manufacturer, Specification developer	0		0	api.fda.gov
Tangent Orthodontics	Franklin, IN, United States	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Taurus Engineering And Manufacturing, Inc.	Saint Paul, MN, 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
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
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, Repackager or relabeler	0		0	api.fda.gov
Wuhu Guli Ortho Co.,ltd	Wuhu Anhui, China	Contract manufacturer, Manufacturer	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
Yuwa Seisakusho KK	Odawara Kanagawa, Japan	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	Contract 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
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, 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
proNet, A Division Desco Industries Inc.	Anaheim, CA, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov

Updated April 20, 1998. 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.