Surgical devices · 21 CFR 872 Subpart E
Orthodontic Band Driver
FDA device type “Driver, Band, Orthodontic”.
- Companies listing it
- 2922 makers
- Brands and models
- 70
- 510(k) clearances
- 00 in five years
- FDA name
- Driver, Band, Orthodontic
Companies that list ECT
29 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Osstem Implant Co., Ltd. | South Korea | Maker | ASMDS | 68 | 2026 |
| Dentium USA | United States | Maker | CRG45L · CRG55L · CRG65L · CRH · +8 | 23 | 2022 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Manual Screwdriver | 1 | 2026 |
| GNI Co., LTD | South Korea | Maker | GNI Ortho | 3 | 2021 |
| Dentos, Inc. | South Korea | Maker | DT-L · DT-S · ED17-L · ED17-S · +21 | 2 | 2019 |
| Surgident Co., Ltd. | South Korea | Maker | Driver Handle · Mallet · Tac Applicator · Tac Remover Driver | 2 | 2019 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| Rmo, Inc. | United States | Maker | Schweickhardt band adapter/SEATERS | 1 | 1990 |
| Zain's Medical Image | Pakistan | Maker | Band Seater · Bite Stick · BITE STICK AND BAND DRIVER · Bite Stick, Plastic · +1 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Driver, Band, Orthodontic | — | — |
| Medcave Private Limited | Pakistan | Maker | Drivers | — | — |
| Lacigrus International | Pakistan | Maker | DRIVER, BAND, ORTHODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | dental driver orthodontic driver | — | — |
| Acheron Instruments (Pvt.) Ltd. | Pakistan | Maker | Drivers | — | — |
| Zhejiang Protect Medical Equipment Co. Ltd. | China | Maker | eurodonto · protect | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Chengdu Sani Medical Equipment CO.,LTD. | China | Maker | Electric Torque Driver | — | — |
| Zhejiang Shinye Medical Technology Corp.,Ltd | China | Maker | BAND | — | — |
| Orthguide Medical Technology (jiangsu) Co., Ltd | China | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Biomaterials Korea, Inc. | South Korea | Foreign exporter | 4809 | 5 | 2023 |
| Dentaurum GmbH & Co. KG | Germany | Foreign exporter | Eby band seater | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Csy International LLC | United States | Repacker / relabeler | J&J Ortho · J&J Orthodontics | — | — |
| Wise Linkers LLC | United States | Repacker / relabeler | Artman Instruments | — | — |
| Ortho Solutions LC | United States | Contract manufacturer | — | — | — |
| White Oak Orthodontic Products | United States | Repacker / relabeler | Infinity | — | — |
Official records: FDA product classification for ECT · 21 CFR 872.4565.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026