Data / Medical devices / Tube, Orthodontic

Tube, Orthodontic (DZD): 84 FDA-registered makers in 13 countries

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

84 establishments in 13 countries are registered with the FDA to make Tube, Orthodontic (product code DZD, Class 1, 21 CFR 872.5410). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on May 23, 1995, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
China	33
United States	17
Mexico	7
Pakistan	6
Brazil	5
Germany	4
South Korea	3
Taiwan	3
Italy	2
Philippines	1
Canada	1
India	1
Japan	1

Makers of Tube, 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	Recall events	Source
Aditek Do Brasil, SA	CRAVINHOS Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Alframed	Sialkot Punjab, Pakistan	Exporter to the US, Manufacturer	0	api.fda.gov
Allure Ortho	Whitinsville, MA, United States	Specification developer	0	api.fda.gov
American Orthodontics	Sheboygan, WI, United States	Manufacturer	0	api.fda.gov
Aso International Manila, Inc.	Cavite,Region IVa,, Philippines	Manufacturer	0	api.fda.gov
Astar Orthodontics Inc.	Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
Calibaja Manufacturing, S.A. De C.V.	MEXICALI Baja California, Mexico	Contract manufacturer	0	api.fda.gov
Changsha Nice Medical Instrument Limited Company	Changsha Hunan, China	Manufacturer	0	api.fda.gov
Creative Dental	Jinhua City Zhejiang, China	Manufacturer	0	api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.	Changsha Hunan, China	Manufacturer	0	api.fda.gov
Dental Morelli Ltda.	SOROCABA Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
E. Tec SA De C.V.	Tijuana Baja California, Mexico	Remanufacturer	0	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Funing Meitedental Factory	Yancheng Jiangsu, China	Manufacturer	0	api.fda.gov
G & H Wire Company	Franklin, IN, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	0	api.fda.gov
GC Orthodontics America Inc.	Alsip, IL, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0	api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Guangzhou Cheer-U Material Technology Co., Ltd	Guangzhou Guangdong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Guangzhou Oo Medical Scientific Limited	Guangzhou Guangdong, China	Manufacturer	0	api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou DTC Medical Apparatus Co., Ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Orthmay Advanced Materials Technology Co., Ltd	Hangzhou City Zhejiang, China	Exporter to the US, Manufacturer	0	api.fda.gov
Hangzhou Pengwu Medical Equipment Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Hangzhou Westlake Biomaterial Co., Ltd.	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, 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
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd	Hangzhou Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Henan Baistra Medical Devices Limited	Zhengzhou Henan, China	Exporter to the US, Manufacturer	0	api.fda.gov
Hespeler Orthodontics Limited	CAMBRIDGE Ontario, Canada	Manufacturer	0	api.fda.gov
Hansfive (Hangzhou) Dental Technology Co.,Ltd	Hangzhou city Zhejiang, China	Manufacturer	0	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi Jiangsu, China	Manufacturer	0	api.fda.gov
Jin Hsiang Ent Co. Ltd	Changhua, Taiwan	Contract manufacturer, Manufacturer	0	api.fda.gov
Jinhua Glamb Medical Equipment Co.,ltd	Jinhua City Zhejiang, China	Exporter to the US, Manufacturer	0	api.fda.gov
Jiscop Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Leone SPA	Sesto Fiorentino Firenze, Italy	Manufacturer	0	api.fda.gov
Mem Dental Technology Co Ltd	Tainan, Taiwan	Manufacturer	0	api.fda.gov
Modern Orthodontics	Ludhiana, Punjab, India	Manufacturer	0	api.fda.gov
Nadir & Co.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Nextcon International	Sialkot Punjab, Pakistan	Contract manufacturer, Manufacturer	0	api.fda.gov
Ningbo Denrotary Medical Apparatus Co., Ltd.	Ningbo City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
O&S Dental, Inc.	Chicago, IL, United States	Manufacturer	0	api.fda.gov
Orthguide Medical Technology (jiangsu) Co., Ltd	Wuxi City Jiangsu, China	Manufacturer, Repackager or relabeler	0	api.fda.gov
Ortho Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler, Specification developer	1	api.fda.gov
Orthodontic Manufacturer Sia SRL	ROCCA D EVANDRO Caserta, Italy	Manufacturer	0	api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.	Marilia Sao Paulo, Brazil	Manufacturer	0	api.fda.gov
Ortompl SA De CV	Tecate Baja California, Mexico	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Ortotec De BC MX SA De CV	Tecate Baja California, Mexico	Manufacturer, Repackager or relabeler	0	api.fda.gov
OSSTEM ORTHODONTICS Inc.	Uiwang-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Ormco Corporation	Pomona, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Ormco Corporation	Brea, CA, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	0	api.fda.gov
PSM Medical GmbH	Gunningen Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
RICOmed Manufacturing	Richardson, TX, United States	Contract manufacturer, Repackager or relabeler	0	api.fda.gov
Rmo	Franklin, IN, United States	Manufacturer	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	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
Sino Ortho Limited	HANGZHOU Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
SKY DENT Corp for dental trading	New York, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Specialty Appliances, LLC	Cumming, GA, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	Manufacturer	0	api.fda.gov
Solventum Germany GmbH	Kamen North Rhine-Westphalia, Germany	Manufacturer	0	api.fda.gov
Solventum Orthodontics Corporation	Monrovia, CA, United States	Complaint file establishment, Manufacturer, Specification developer	0	api.fda.gov
Tecnident Equipamentos Ortodonticos Ltda.	SAO CARLOS Sao Paulo, Brazil	Exporter to the US, Manufacturer, Repackager or relabeler	0	api.fda.gov
Tomy, Inc.	Iwaki City Fukushima, Japan	Manufacturer	0	api.fda.gov
TP Orthodontics, Inc.	La Porte, IN, United States	Manufacturer	0	api.fda.gov
The American Angle, LLC	Brooklyn, NY, United States	Contract manufacturer, Specification developer	0	api.fda.gov
Ultimate Do Brasil Importacao E Exportacao Ltda.	SAO JOSE DOS CAMPOS Sao Paulo, Brazil	Contract manufacturer	0	api.fda.gov
Ultimate Wireforms, Inc.	Bristol, CT, United States	Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer	0	api.fda.gov
Univy Technology Advanced Co. Ltd	Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
Waqas Surgical Instruments	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Win Wings Corp.	SIALKOT Punjab, Pakistan	Manufacturer	0	api.fda.gov
World Class Technology Corporation	Mcminnville, OR, United States	Manufacturer	0	api.fda.gov
Wuhu Guli Ortho Co.,ltd	Wuhu Anhui, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Zain's Medical Image	SIALKOT Punjab, Pakistan	Manufacturer	0	api.fda.gov
Ze Fang Technology Co., Ltd.	Taichung, Taiwan	Manufacturer	0	api.fda.gov
Zhejiang Eksen Medical Technology Co., Ltd	Huzhou Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Zhejiang Headway Medical Equipment Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	0	api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.	Anji Zhejiang, China	Manufacturer	0	api.fda.gov
Zhejiang Risheng Medical Technology Co., Ltd	Hangzhou Zhejiang, 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 Yo Medical Technology Co., Ltd	Huzhou Zhejiang, China	Manufacturer	0	api.fda.gov
Zhejiang Shinye Medical Technology Corp.,Ltd	HANGZHOU Zhejiang, China	Manufacturer	0	api.fda.gov
Zhejiang Yahong Medical Apparatus Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	0	api.fda.gov

Updated May 23, 1995. 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.