Data / Medical devices / Band, Preformed, Orthodontic

Band, Preformed, Orthodontic (ECM): 59 FDA-registered makers in 12 countries

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

59 establishments in 12 countries are registered with the FDA to make Band, Preformed, Orthodontic (product code ECM, Class 1, 21 CFR 872.5410). 0 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 May 27, 1993, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
China	26
United States	14
Mexico	5
Germany	4
Italy	3
Philippines	1
South Korea	1
Taiwan	1
India	1
Pakistan	1
Brazil	1
Japan	1

Makers of Band, Preformed, 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	Source
Allure Ortho	Whitinsville, MA, United States	Specification developer	api.fda.gov
American Orthodontics	Sheboygan, WI, United States	Manufacturer	api.fda.gov
Aso International Manila, Inc.	Cavite,Region IVa,, Philippines	Manufacturer	api.fda.gov
Astar Orthodontics Inc.	Shanghai, China	Manufacturer	api.fda.gov
Calibaja Manufacturing, S.A. De C.V.	MEXICALI Baja California, Mexico	Contract manufacturer	api.fda.gov
Creative Dental	Jinhua City Zhejiang, China	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
Denovo Dental Inc	Baldwin Park, CA, United States	Manufacturer	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
E. Tec SA De C.V.	Tijuana Baja California, Mexico	Remanufacturer	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
G & H Wire Company	Franklin, IN, United States	Manufacturer, Repackager or relabeler	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Guangzhou Cheer-U Material Technology Co., Ltd	Guangzhou Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Guangzhou Oo Medical Scientific Limited	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Hangzhou DTC Medical Apparatus Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Hangzhou Orthmay Advanced Materials Technology Co., Ltd	Hangzhou City Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Hangzhou Westlake Biomaterial Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
HDC S.R.L.	THIENE Vicenza, Italy	Manufacturer	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Manufacturer	api.fda.gov
Hansfive (Hangzhou) Dental Technology Co.,Ltd	Hangzhou city Zhejiang, China	Manufacturer	api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer	api.fda.gov
Mem Dental Technology Co Ltd	Tainan, Taiwan	Manufacturer	api.fda.gov
Modern Orthodontics	Ludhiana, Punjab, India	Manufacturer	api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.	Ningbo City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Orthguide Medical Technology (jiangsu) Co., Ltd	Wuxi City Jiangsu, China	Manufacturer, Repackager or relabeler	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	api.fda.gov
Ortho-Tain, Inc.	Toa Alta, PR, United States	Manufacturer	api.fda.gov
Orthodontic Manufacturer Sia SRL	ROCCA D EVANDRO Caserta, Italy	Manufacturer	api.fda.gov
Ortotec De BC MX SA De CV	Tecate Baja California, Mexico	Contract manufacturer, Repackager or relabeler	api.fda.gov
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Specification developer	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	api.fda.gov
Rmo	Franklin, IN, United States	Manufacturer	api.fda.gov
SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, Mexico	Contract manufacturer	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	api.fda.gov
Shenzhen Rogin Medical Co., Ltd	shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Specialty Appliances, LLC	Cumming, GA, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Surgicrafts	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	Manufacturer	api.fda.gov
Solventum Germany GmbH	Kamen North Rhine-Westphalia, Germany	Manufacturer	api.fda.gov
Solventum Orthodontics Corporation	Monrovia, CA, United States	Complaint file establishment, Manufacturer, Specification developer	api.fda.gov
Tecnident Equipamentos Ortodonticos Ltda.	SAO CARLOS Sao Paulo, Brazil	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Tomy, Inc.	Iwaki City Fukushima, Japan	Manufacturer	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	api.fda.gov
Wuxi TP Orthodontics Material Co., Ltd.	WUXI Jiangsu, China	Manufacturer	api.fda.gov
Yancheng Denrum Medical Apparatus Co.,ltd.	Yancheng Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Eksen Medical Technology Co., Ltd	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.	Anji Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Risheng Medical Technology Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.	Yang Jiao Lang Zin'an Town Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Yo Medical Technology Co., Ltd	Huzhou Zhejiang, China	Manufacturer	api.fda.gov
ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, China	Manufacturer	api.fda.gov
Zhejiang Shinye Medical Technology Corp.,Ltd	HANGZHOU Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Yahong Medical Apparatus Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov

Updated May 27, 1993. 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.