Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Material Band
FDA device type “Band, Material, Orthodontic”.
- Companies listing it
- 4534 makers
- Brands and models
- 59
- 510(k) clearances
- 30 in five years
- FDA name
- Band, Material, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list DYO
45 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Biomaterials Korea, Inc. | South Korea | Maker | ACR | 5 | 2023 |
| Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | Germany | Maker | Mediloy RPD | 4 | 2013 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| GC Orthodontics | United States | Maker | GC Orthodontics | 2 | 2015 |
| ORTHO-TAIN, Inc. | United States | Maker | CLASS III GUIDE · HABIT-CORRECTOR · HAWLEY-FORM · INTERIM "G" RETAINER · +4 | 2 | 1998 |
| Dental Morelli | Brazil | Maker | — | 2 | 2014 |
| Rmo, Inc. | United States | Maker | Truform | 1 | 1990 |
| World Class Technology Corporation | United States | Maker | Duraband · Fierro · orthodontic band | 1 | 2019 |
| Dentaurum GmbH & Co. KG | Germany | Maker | Band material | — | — |
| Orthometric Ind. e Com. de Prod. Med. Odont. | Brazil | Maker | ORTHOMETRIC BANDS | — | — |
| Shanghai Dochem Industries Co., Ltd. | China | Maker | Arch Wires · Ligature Ties · Power Chains | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | BK MASK blue · BK MASK ivory · BK MASK violet · FACEMASK BL Org · +3 | — | — |
| Solventum US LLC | United States | Maker | — | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | SIA ORTHODONTIC MANUFACTURER | — | — |
| Innovative Material And Devices, Inc. | China | Maker | 1st Molar Etched Interior, 2nd Molar Etched Interior | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Produits Dentaires SA | Switzerland | Maker | Matrix bands | — | — |
| Astar Orthodontics Inc | China | Maker | band | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | Band.Material. Orthodontic | — | — |
| Changsha Nice Medical Instrument Limited Company | China | Maker | Niceortho Band, Orthodontic | — | — |
| Wuhu Guli Ortho Co.,Ltd | China | Maker | Orthodontic bands | — | — |
| Changsha Easyinsmile Intelligence Technology Co.,Ltd. | China | Maker | Band, Material, Orthodontic | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Orthodontic Band Material | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, Orthodontic seperators | — | — |
| Sino Ortho Limited | China | Maker | Molar band | — | — |
| Asanus Medizintechnik GmbH | Germany | Maker | ASANUS | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Band, Material, Orthodontic | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Orthodontic Band | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Yangjiang Kaimi Import Export Co.,Ltd | China | Maker | BAND, MATERIAL, ORTHODONTIC | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | orthguide | — | — |
| Progressive America Inc | United States | Maker | Medit Orthodontic Suite | — | — |
| Sichuan Yaqi Medical Technology Co., Ltd. | China | Maker | Dental Sheet | — | — |
| American Orthodontics | United States | Contract manufacturer | Band Material | 44 | 2026 |
| Five Star Orthodontic Laboratory & Supply, Inc. | United States | Contract manufacturer | — | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Csy International LLC | United States | Repacker / relabeler | Caber · J&J Ortho · J&J Orthodontics | — | — |
| First Dental Supplies LLC | United States | Repacker / relabeler | band, material, orthodontic | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Band | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Saga Dental Supply A | Norway | Contract manufacturer | Band | — | — |
| Shanghai Smartee Denti-Technology Co., Ltd. | China | Foreign exporter | Dental Sheet | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 31 Jan 1994 | K935152 | DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD | Dentauraum, Inc. |
| 1 Sep 1993 | K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | Ortho Organizers, Inc. |
| 23 Jan 1985 | K844034 | SONOCARE | Echo Ultrasound |
Official records: FDA product classification for DYO · 21 CFR 872.5410.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026