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Data / Medical devices / Band, Material, Orthodontic

Band, Material, Orthodontic (DYO): 34 FDA-registered makers in 9 countries

34 establishments in 9 countries are registered with the FDA to make Band, Material, Orthodontic (product code DYO, 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 3 510(k) clearances under this code, the latest on January 31, 1994, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
DYO
Device class
1
Regulation
872.5410
Medical specialty
Dental

Makers by country

CountryMakers
China15
United States6
Germany3
South Korea3
Brazil3
Mexico1
Italy1
Switzerland1
Japan1

Makers of Band, Material, 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
Asanus Medizintechnik GMBHNEUHAUSEN OBECK Baden-Wurttemberg, GermanyManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Astar Orthodontics Inc.Shanghai, ChinaExporter to the US, Manufacturer0000api.fda.gov
Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KGBremen, GermanyManufacturer0000api.fda.gov
Biomaterials Korea Inc.Hanam-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Changsha Nice Medical Instrument Limited CompanyChangsha Hunan, ChinaManufacturer0000api.fda.gov
Changsha Easyinsmile Intelligence Technology Co.Ltd.Changsha Hunan, ChinaManufacturer0000api.fda.gov
Dental Morelli Ltda.SOROCABA Sao Paulo, BrazilManufacturer0000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
E. Tec SA De C.V.Tijuana Baja California, MexicoRemanufacturer0000api.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
Guangzhou Oo Medical Scientific LimitedGuangzhou Guangdong, ChinaManufacturer0000api.fda.gov
Hangzhou Angsheng Orthodontic Products Co., LtdHangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Innovative Material & Devices, Inc.Wuxi Jiangsu, ChinaManufacturer0000api.fda.gov
Orthguide Medical Technology (jiangsu) Co., LtdWuxi City Jiangsu, ChinaManufacturer, Repackager or relabeler0000api.fda.gov
Ortho-Tain, Inc.Toa Alta, PR, United StatesManufacturer0000api.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
OSSTEM ORTHODONTICS Inc.Uiwang-si Gyeonggi, South KoreaManufacturer0000api.fda.gov
Produits Dentaires SAVEVEY (SUISSE) Vaud, SwitzerlandManufacturer0000api.fda.gov
Progressive Orthodontics USAAliso Viejo, CA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
RmoFranklin, IN, United StatesManufacturer0000api.fda.gov
Shanghai Dochem Industries Co., Ltd.Shanghai, ChinaManufacturer0000api.fda.gov
Sichuan Yaqi Medical Technology Co., Ltd.Ziyang Sichuan, ChinaExporter to the US, Manufacturer0000api.fda.gov
Sino Ortho LimitedHANGZHOU Zhejiang, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Tecnident Equipamentos Ortodonticos Ltda.SAO CARLOS Sao Paulo, BrazilExporter to the US, Manufacturer, Repackager or relabeler0000api.fda.gov
Tomy, Inc.Iwaki City Fukushima, JapanManufacturer0000api.fda.gov
World Class Technology CorporationMcminnville, OR, United StatesManufacturer0000api.fda.gov
Wuhu Guli Ortho Co.,ltdWuhu Anhui, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Yangjiang Kaimi Import Export Co.,ltdYangjiang Guangdong, ChinaManufacturer0000api.fda.gov
Zhejiang Protect Medical Equipment Co. Ltd.Anji Zhejiang, ChinaManufacturer0000api.fda.gov
Zhejiang Yamei Medical Equipment Technology Co., Ltd.Yang Jiao Lang Zin'an Town Zhejiang, ChinaManufacturer0000api.fda.gov

Updated January 31, 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.