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Data / Medical devices / Spring, Orthodontic

Spring, Orthodontic (ECO): 60 FDA-registered makers in 11 countries

60 establishments in 11 countries are registered with the FDA to make Spring, Orthodontic (product code ECO, 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 7 510(k) clearances under this code, the latest on August 17, 1994, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in ChinaWatch this device
Product code
ECO
Device class
1
Regulation
872.5410
Medical specialty
Dental

Makers by country

CountryMakers
China21
United States17
South Korea6
Brazil4
Germany3
Italy2
Taiwan2
Mexico2
Canada1
India1
Japan1

Makers of Spring, 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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Acme-Monaco Corp.New Britain, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Acme-Monaco Corp.Presque Isle, ME, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Aditek Do Brasil, SACRAVINHOS Sao Paulo, BrazilManufacturer0000api.fda.gov
American OrthodonticsSheboygan, WI, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Astar Orthodontics Inc.Shanghai, ChinaManufacturer0000api.fda.gov
Beijing Smart Technology Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Biomaterials Korea Inc.Hanam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Changsha Nice Medical Instrument Limited CompanyChangsha Hunan, ChinaManufacturer0000api.fda.gov
Debo Medical Technology (shijiazhuang) Co., Ltd.Shijiazhuang Hebei, ChinaContract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
Dentos, IncorporatedDaegu, South KoreaManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
Digital Dental Laboratories, DBA OrthodentOshawa Ontario, CanadaManufacturer0000api.fda.gov
Forestadent Bernhard Forster GMBHPFORZHEIM Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
G & H Wire CompanyFranklin, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
GC Orthodontics America Inc.Alsip, IL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler0000api.fda.gov
GNI Co., LTDHwaseong-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Guangzhou Cheer-U Material Technology Co., LtdGuangzhou Guangdong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Hangzhou DTC Medical Apparatus Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Pengwu Medical Equipment Co.,ltdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Wise Medical Device Co.,ltdHangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Heilongjiang Rainbow Technology Co., Ltd.Jiamusi Heilongjiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
HT Co., Ltd.Yongin-si Gyeonggi, South KoreaContract manufacturer, Manufacturer0000api.fda.gov
Hansfive (Hangzhou) Dental Technology Co.,LtdHangzhou city Zhejiang, ChinaManufacturer0000api.fda.gov
Improve Co.,limitedLantau Island Hong Kong, ChinaContract manufacturer, Exporter to the US0000api.fda.gov
Innovative Material & Devices, Inc.Wuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Jiscop Co., Ltd.Gunpo-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Leone SPASesto Fiorentino Firenze, ItalyManufacturer, Specification developer0000api.fda.gov
Matrix Health, Inc.Greenville, SC, United StatesSpecification developer0000api.fda.gov
Mem Dental Technology Co LtdTainan, TaiwanManufacturer0000api.fda.gov
Modern OrthodonticsLudhiana, Punjab, IndiaManufacturer0000api.fda.gov
Orthguide Medical Technology (jiangsu) Co., LtdWuxi City Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Orthodontic Manufacturer Sia SRLROCCA D EVANDRO Caserta, ItalyManufacturer0000api.fda.gov
Orthometric Ind. E Com. De Prod. Med. Odont.Marilia Sao Paulo, BrazilManufacturer0000api.fda.gov
Ortompl SA De CVTecate Baja California, MexicoContract manufacturer, Repackager or relabeler0000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ortho Traction PadsNorwalk, CT, United StatesContract manufacturer, Manufacturer0000api.fda.gov
PSM Medical GmbHGunningen Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
RmoFranklin, IN, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Shenzhen Denco Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Shenzhen Rogin Medical Co., Ltdshenzhen Guangdong, ChinaContract manufacturer, Exporter to the US, Manufacturer0000api.fda.gov
Sino Ortho LimitedHANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Tangent OrthodonticsFranklin, IN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Tomy, Inc.Iwaki City Fukushima, JapanManufacturer0000api.fda.gov
TP Orthodontics, Inc.La Porte, IN, United StatesManufacturer0010api.fda.gov
Ultimate Do Brasil Importacao E Exportacao Ltda.SAO JOSE DOS CAMPOS Sao Paulo, BrazilContract manufacturer0000api.fda.gov
Ultimate Wireforms, Inc.Bristol, CT, United StatesContract manufacturer, Manufacturer, Specification developer0000api.fda.gov
World Bio Tech Co LtdSeongnam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
World Class Technology CorporationMcminnville, OR, United StatesManufacturer0000api.fda.gov
Wuhu Guli Ortho Co.,ltdWuhu Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Xingyue Medical Health Technology (nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer0000api.fda.gov
Zalinsky Ortho Parts, LLCCharlotte, NC, United StatesSpecification developer0000api.fda.gov
Ze Fang Technology Co., Ltd.Taichung, TaiwanManufacturer0000api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.Anji Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yo Medical Technology Co., LtdHuzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Shinye Medical Technology Corp.,LtdHANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov

Updated August 17, 1994. 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.