Data / Medical devices / Wire, Orthodontic

Wire, Orthodontic (DZC): 122 FDA-registered makers in 13 countries

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

122 establishments in 13 countries are registered with the FDA to make Wire, Orthodontic (product code DZC, 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 30 510(k) clearances under this code, the latest on November 16, 2011, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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

Makers by country

Country	Makers
China	42
United States	32
Germany	10
South Korea	10
Mexico	6
Brazil	5
Taiwan	4
India	4
Pakistan	2
Japan	2
Canada	2
Italy	2
Poland	1

Makers of Wire, 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
Five Star Orthodontic Laboratory & Supply, Inc.	Denton, TX, United States	Contract manufacturer, Manufacturer, Repackager or relabeler	4	March 31, 1993	0	api.fda.gov
Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, Germany	Manufacturer	1	February 4, 1994	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
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Alframed	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Alta Smiles, LLC	Fort Washington, PA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
American Orthodontics	Sheboygan, WI, United States	Complaint file establishment, Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Aseptico, Inc.	Woodinville, WA, United States	Manufacturer	0		0	api.fda.gov
Astar Orthodontics Inc.	Shanghai, China	Manufacturer	0		0	api.fda.gov
Beijing Smart Technology Co., Ltd.	Beijing, China	Manufacturer	0		0	api.fda.gov
Biomaterials Korea Inc.	Hanam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
BRIUS Technologies Inc.	Carrollton, TX, United States	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
Chikami Miltec, Inc.	Kochi, Japan	Manufacturer	0		0	api.fda.gov
CM Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
COHO Advanced Materials Tech. Co., Ltd.	Luzhu District Taoyuan, Taiwan	Manufacturer	0		0	api.fda.gov
Comfort Surgical Instruments	Sialkot Punjab, Pakistan	Manufacturer	0		0	api.fda.gov
Creative Dental	Jinhua City Zhejiang, China	Manufacturer	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
Dany BMT Co., Ltd.	Anyang-si Gyeonggi, South Korea	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
Dimeda Instrumente GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0		0	api.fda.gov
Dentsply Sirona Orthodontics Inc.	Sarasota, FL, United States	Contract manufacturer	0		0	api.fda.gov
Dentsply Sirona Orthodontics Inc.	Richardson, TX, United States	Specification developer	0		0	api.fda.gov
E. Tec SA De C.V.	Tijuana Baja California, Mexico	Remanufacturer	0		0	api.fda.gov
Forestadent Bernhard Forster GMBH	PFORZHEIM Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Fabryka Narzedzi Medycznych CHIRMED Marcin Dyner Spolka Komandytowa	RUDNIKI K/CZESTOCHOWY Slaskie, Poland	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	Contract manufacturer, Manufacturer, Repackager or relabeler	0		1	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
Gergens Orthodontic Lab	Phoenix, AZ, United States	Contract manufacturer	0		0	api.fda.gov
GNI Co., LTD	Hwaseong-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Guangxi Ehall Medical Technology Co.,ltd	Nanning Guangxi, China	Exporter to the US, 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 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	Manufacturer	0		0	api.fda.gov
Heilongjiang Rainbow Technology Co., Ltd.	Jiamusi Heilongjiang, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Helmut Zepf Medizintechnik GMBH	SEITINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Hespeler Orthodontics Limited	CAMBRIDGE Ontario, Canada	Manufacturer, Specification developer	0		0	api.fda.gov
HT Co., Ltd.	Yongin-si Gyeonggi, South Korea	Contract manufacturer, 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
Hansfive (Hangzhou) Dental Technology Co.,Ltd	Hangzhou city Zhejiang, China	Manufacturer	0		0	api.fda.gov
Innovative Material & Devices, Inc.	Wuxi Jiangsu, China	Manufacturer	0		0	api.fda.gov
Jin Hsiang Ent Co. Ltd	Changhua, Taiwan	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Jiscop Co., Ltd.	Gunpo-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Kreidler Medizintechnik GmbH	Wurmlingen Baden-Wurttemberg, Germany	Contract 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
Lorelli Technologies LLC	Fountain Valley, CA, United States	Manufacturer	0		0	api.fda.gov
Matrix Health, Inc.	Greenville, SC, United States	Specification developer	0		0	api.fda.gov
Medicon, E.G.	TUTTLINGEN Baden-Wurttemberg, Germany	Manufacturer	0		0	api.fda.gov
Mem Dental Technology Co Ltd	Tainan, Taiwan	Manufacturer	0		0	api.fda.gov
MK Meditech	Seongnam-si Gyeonggi, South Korea	Manufacturer	0		0	api.fda.gov
Modern Orthodontics	Ludhiana, Punjab, India	Manufacturer	0		0	api.fda.gov
Mothers Medica Private Limited	Chennai Tamil Nadu, India	Manufacturer	0		0	api.fda.gov
Modern Dental Laboratory (DG) Co., Ltd.	Dongguan Guangdong, China	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 Organizers, Inc.	Savannah, GA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortho-Tain, Inc.	Toa Alta, PR, United States	Manufacturer	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
Ortompl SA De CV	Tecate Baja California, Mexico	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Ortotec De BC MX SA De CV	Tecate Baja California, Mexico	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
OSSTEM ORTHODONTICS Inc.	Uiwang-si Gyeonggi, South Korea	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
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	Contract manufacturer	0		0	api.fda.gov
Reliance Orthodontic Products, Inc.	Itasca, IL, United States	Repackager or relabeler, Specification developer	0		0	api.fda.gov
RICOmed Manufacturing	Richardson, TX, United States	Contract manufacturer, Repackager or relabeler	0		0	api.fda.gov
Rmo	Franklin, IN, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sawbros Industries Pvt Ltd	NOIDA Uttar Pradesh, India	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Scheu-Dental GMBH	ISERLOHN North Rhine-Westphalia, Germany	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
Shandong Hengfeng Kerui Medical Equipment Co., Ltd	Qingdao City Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	0		0	api.fda.gov
Shanghai Kangqiao Dental Instruments Factory	Shanghai, China	Exporter to the US, Manufacturer	0		0	api.fda.gov
Shenzhen Denco Medical Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Manufacturer	0		0	api.fda.gov
Shenzhen HLD Dental&technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Perfect Medical Instruments Co., Ltd.	Shenzhen Guangdong, China	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
Shenzhen Superline Technology Co.,ltd	Shenzhen Guangdong, China	Manufacturer	0		0	api.fda.gov
Shenzhen Times Dental Lab	Shenzhen Guangdong, China	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
Specialty Appliances, LLC	Cumming, GA, United States	Manufacturer, Repackager or relabeler	0		0	api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	Manufacturer	0		0	api.fda.gov
Smarter Alloys	Cambridge Ontario, Canada	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
Tangent Orthodontics	Franklin, IN, United States	Contract manufacturer, 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
Ultimate Do Brasil Importacao E Exportacao Ltda.	SAO JOSE DOS CAMPOS Sao Paulo, Brazil	Contract manufacturer	0		0	api.fda.gov
Ultimate Wireforms, Inc.	Bristol, CT, United States	Contract manufacturer, 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
Vivos Therapeutics INC.	Murray, KY, United States	Specification developer	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
Wire and Cable Specialties, Inc.	Coatesville, PA, United States	Contract 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
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 Yamei Medical Equipment Technology Co., Ltd.	Yang Jiao Lang Zin'an Town Zhejiang, China	Manufacturer	0		0	api.fda.gov
Zhejiang Shinye Medical Technology Corp.,Ltd	HANGZHOU Zhejiang, China	Manufacturer	0		0	api.fda.gov

Updated November 16, 2011. 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.