Osung MND
A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is…
A hand-held device intended to be used by laypersons to remove/apply orthodontic elastomeric appliances (e.g., inter-arch bands, inter-bracket chains) from/to orthodontic brackets. It is typically a thin plastic device with a hook on one end and a pusher on the other, intended to be used by a patient in the home (e.g., before and after eating or sleep). This is a single-use device.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Huanghua DK Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 37 |
| Zhengzhou Huaer Electro-Optics Technology Co., Ltd. | Zhengzhou | Henan | Contract manufacturer | 21 |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 19 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Shenzhen Sunmc Dental Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Jiangsu Province Yangzhou Shuguang Toothbrush Manufactory | Yang Zhou | Jiangsu | Manufacturer | 15 |
| Ningbo Denrotary Medical Apparatus Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 9 |
| Pesitro Healthcare Products Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 7 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | ECS |
| Device type | Pusher, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3ORWBP1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 25 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 15 |
| Chewies ™ | Dentsply Sirona Orthodontics Inc. | 12 |
| JMU | JMU Dental, Inc | 9 |
| Ortho Technology® | Ortho Organizers, Inc. | 9 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 8 |
| Precision Dental Instruments | Precision Dental Instruments | 7 |
| Leone SPA | Leone SPA | 7 |
| Zoll Dental | Zoll-Dental | 6 |
| Color Coded Bite Sticks | Ortho Technology, Inc. | 6 |
| Young Specialties | Young Innovations Inc. | 5 |
Showing 12 of 47. All products under Pusher, Band, Orthodontic
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.