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
| Country | Makers |
|---|---|
| China | 15 |
| United States | 6 |
| Germany | 3 |
| South Korea | 3 |
| Brazil | 3 |
| Mexico | 1 |
| Italy | 1 |
| Switzerland | 1 |
| Japan | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Asanus Medizintechnik GMBH | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Astar Orthodontics Inc. | Shanghai, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bego Bremer Goldschlaegerei Wilh. Herbst GMBH & Co. KG | Bremen, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomaterials Korea Inc. | Hanam-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Nice Medical Instrument Limited Company | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Changsha Easyinsmile Intelligence Technology Co.Ltd. | Changsha Hunan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Morelli Ltda. | SOROCABA Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentaurum GmbH & Co. KG | ISPRINGEN Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E. Tec SA De C.V. | Tijuana Baja California, Mexico | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GC Orthodontics America Inc. | Alsip, IL, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| GNI Co., LTD | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Cheer-U Material Technology Co., Ltd | Guangzhou Guangdong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangzhou Oo Medical Scientific Limited | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Angsheng Orthodontic Products Co., Ltd | Hangzhou Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Material & Devices, Inc. | Wuxi Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthguide Medical Technology (jiangsu) Co., Ltd | Wuxi City Jiangsu, China | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ortho-Tain, Inc. | Toa Alta, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthodontic Manufacturer Sia SRL | ROCCA D EVANDRO Caserta, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orthometric Ind. E Com. De Prod. Med. Odont. | Marilia Sao Paulo, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| OSSTEM ORTHODONTICS Inc. | Uiwang-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Produits Dentaires SA | VEVEY (SUISSE) Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Progressive Orthodontics USA | Aliso Viejo, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rmo | Franklin, IN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Dochem Industries Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sichuan Yaqi Medical Technology Co., Ltd. | Ziyang Sichuan, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sino Ortho Limited | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Orthodontics Corporation | Monrovia, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tecnident Equipamentos Ortodonticos Ltda. | SAO CARLOS Sao Paulo, Brazil | Exporter to the US, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tomy, Inc. | Iwaki City Fukushima, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| World Class Technology Corporation | Mcminnville, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wuhu Guli Ortho Co.,ltd | Wuhu Anhui, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangjiang Kaimi Import Export Co.,ltd | Yangjiang Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Protect Medical Equipment Co. Ltd. | Anji Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin'an Town Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.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.