Therapeutic devices · 21 CFR 872 Subpart F
Orthodontic Preformed Band
FDA device type “Band, Preformed, Orthodontic”.
- Companies listing it
- 8055 makers
- Brands and models
- 139
- 510(k) clearances
- 20 in five years
- FDA name
- Band, Preformed, Orthodontic
510(k) clearances per year, 1976–2026
Companies that list ECM
80 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sybron Dental Specialties | United States | Maker | — | 203 | 2026 |
| American Orthodontics | United States | Maker | Anteriors · Contoured · Mini Skirt Crowns · MR · +4 | 44 | 2026 |
| Ortho Organizers, Inc. | United States | Maker | ACCUFIT BANDS · Andrews2 Band Assemblies · BANDS · BICUSPID BANDS · +5 | 8 | 2025 |
| Tp Orthodontics, Inc. | United States | Maker | Molar Band · Molar Band Assemblies · PRE-FIT PREFORMED BANDS | 5 | 2022 |
| Leone S.P.A. | Italy | Maker | CALIBRA · WEB | 4 | 2025 |
| Mem Dental Technology Co., Ltd. | Taiwan | Maker | — | 2 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Molar Bands | 1 | 2025 |
| Forestadent Bernhard Forster GmbH | Germany | Maker | Orthodontic Molar Bands | 4 | 2011 |
| Tomy, Inc. | Japan | Maker | — | 4 | 2018 |
| GNI Co., LTD | South Korea | Maker | BAND, PREFORMED | 3 | 2021 |
| Hdc S.R.L. | Italy | Maker | Orthodontic Anchorage Attachment | 3 | 2009 |
| G&H Wire Company | United States | Maker | SATURN · Straight-Line · TITAN | 2 | 2008 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| ORTHO-TAIN, Inc. | United States | Maker | NITE-GUIDE PREFORMED ACTIVATOR · OCCLUS-O-GUIDE · OCCLUS-O-GUIDE PREFORMED ACTIVATOR · ORTHO-TAIN · +1 | 2 | 1998 |
| Rmo, Inc. | United States | Maker | Truform | 1 | 1990 |
| ASO International Manila, Inc. | Philippines | Maker | Customized Bands | 1 | 2021 |
| Dentaurum GmbH & Co. KG | Germany | Maker | dentaform · dentaform band · dentaform Snap band · Standard band · +1 | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | dental band · dental model · Dental Polishing Brush · elastic chain · +12 | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Molar Bands | — | — |
| Denovo Dental Inc | United States | Maker | D071514 · D071515 · D071516 · D071517 · +4 | — | — |
| Hangzhou Westlake Biomaterial Co., Ltd. | China | Maker | Band, Preformed, Orthodontic · Band, Preformed, Orthodontic (All types of orthodontic Stainless Steel bands) · XIHUBIOM | — | — |
| ZOGEAR Medical Co., Ltd. | China | Maker | BAND, PREFORMED, ORTHODONTIC | — | — |
| Hangzhou Orthmay Advanced Materials Technology Co., Ltd | China | Maker | Orthodontic Band | — | — |
| Solventum US LLC | United States | Maker | Unitek (TM) Bands · Victory Series (TM) Bands | — | — |
| Surgicrafts | Pakistan | Maker | ECM / BAND, PREFORMED, ORTHODONTIC | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | SIA ORTHODONTIC MANUFACTURER | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | Eurodonto · Protect | — | — |
| Astar Orthodontics Inc | China | Maker | Guchi bands · Kola band · Premolar Band · 1st Molar Band · +1 | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Orthodontic Band | — | — |
| Specialty Appliances, LLC | United States | Maker | Orthodontic Bands | — | — |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | China | Maker | — | — | — |
| Guangzhou Cheer-U Material Technology Co., Ltd | China | Maker | Preformed Orthodontic Band | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental, Orthodontic molar band | — | — |
| SKY DENT Corp for dental trading | United States | Maker | SKY DENT ORTHODONTIC BAND - 1DERFUL ORTHODONTIC BAND | — | — |
| Hangzhou Angsheng Orthodontic Products Co. Ltd | China | Maker | Band Performed Orthodontic | — | — |
| Universal Orthodontic Lab, Inc. | United States | Maker | Preformed Orthodontic Band | — | — |
| Zhejiang Eksen Medical Technology Co., Ltd | China | Maker | Orthodontic Band | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | BAND | — | — |
| Hangzhou DTC Medical Apparatus Co., Ltd | China | Maker | Dental Bands;DTC;Orthodontics | — | — |
| Modern Orthodontics | India | Maker | AccuForm | — | — |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | China | Maker | molar bands | — | — |
| Sharp Detail Orthodontic Laboratory | United States | Maker | BAND, PREFORMED, ORTHODONTIC | — | — |
| Zhejiang YO Medical Technology Co., Ltd | China | Maker | DENTMAS; GLOBAL DENTAL; Orthodontics; TEXDENT | — | — |
| Tecnident Equipamentos Ortodonticos Ltda. | Brazil | Maker | TECNIDENT EQUIPAMENTOS ORTODONTICOS | — | — |
| Hansfive (Hangzhou) Dental Technology Co., Ltd. | China | Maker | Orthodontic Band | — | — |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd | China | Maker | hangzhou 3B | — | — |
| Zhejiang Yahong Medical Apparatus Co., Ltd | China | Maker | Yahong | — | — |
| Creative Dental | China | Maker | Band | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Yancheng Denrum Medical Apparatus Co Ltd | China | Maker | Orthodontic Bands | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| MPL Manufacturing Inc. | United States | Maker | Metal Band | — | — |
| Zhejiang Risheng Medical Technology Co Ltd | China | Maker | — | — | — |
| Allure Ortho | United States | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Parkell, Inc | United States | Contract manufacturer | — | 58 | 2025 |
| Myofunctional Research Co. Usa Inc. | United States | Foreign exporter | BWS Band | 3 | 2026 |
| DB Orthodontics Limited | United Kingdom | Foreign exporter | Evolve Molar Bands | 2 | 2010 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ORTHOM | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | 1st Molar Rough Band w/ MBT Tube · 1st Molar Rough Band w/ Roth Tube | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson® Plain First Molar Bands | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | Band Plain promax bands · cleats · ligual sheath · orthodontic band · +3 | — | — |
| International Orthodontics Services. PC | United States | Repacker / relabeler | IOS True Band | — | — |
| Csy International LLC | United States | Repacker / relabeler | Caber · J&J Ortho · J&J Orthodontics | — | — |
| Forestadent Usa | United States | Repacker / relabeler | BAND | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Infinity · Novis | — | — |
| US Orthodontic Products | United States | Repacker / relabeler | Orthodontic Band | — | — |
| Fairfield Orthodontics, LLC | United States | Repacker / relabeler | BEST FIT MOLAR BANDS · FAIRFIELD BANDS · TITAN MOLAR BANDS | — | — |
| Phoenix Orthodontics Inc | United States | Repacker / relabeler | Phoenix M Series Molar Bands · Phoenix Nickel Titanium Wires · Phoenix Original Series Molar Bands · Phoenix Stainless Kobayashi Tie Hooks · +2 | — | — |
| Orthone INC. | United States | Repacker / relabeler | orthone | — | — |
| Saga Dental Supply A | Norway | Contract manufacturer | Band | — | — |
| O&S Dental Inc | United States | Manufacturer for export | — | — | — |
| Shaw Dental Laboratories Corp. | United States | Repacker / relabeler | Preformed Ortho Band | — | — |
| Tangent Technologies LLC | United States | Contract manufacturer | Orthodontic Bands | — | — |
| Orthodentalusa Corp. | United States | Repacker / relabeler | — | — | — |
| Yiwu Daqida Plastic Products Co., Ltd. | China | Foreign exporter | Mouth Guard | — | — |
| DentOrtho LLC | United States | Repacker / relabeler | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 May 1993 | K925163 | MICODOSE CHLORHEXIPREP | Unicep |
| 11 Sep 1987 | K872471 | TITANE SL DENTAL BURR | Titane SL Co. |
Official records: FDA product classification for ECM · 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