HU-Friedy
Band Pusher #2/Scaler 678-904, #6 Handle
12manufacturers in China registered for this device type
25catalogue numbers in this listing
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 | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | ECS |
| Device type | Pusher, Band, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-11-12 |
| Record revised | 2022-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2022-01-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PI8126 | In distribution | |
| PI5179 | In distribution | |
| BP5290 | In distribution | |
| BPS1 | In distribution | |
| 678-906 | In distribution | |
| 678-904 | In distribution | |
| PI5339 | In distribution | |
| 678-912 | In distribution | |
| PI5350 | In distribution | |
| BP7165 | In distribution | |
| PI7075 | In distribution | |
| BP5461 | In distribution | |
| PI6543 | In distribution | |
| PI7133 | In distribution | |
| PI7010 | In distribution | |
| PI6640 | In distribution | |
| PI5181 | In distribution | |
| BP5012 | In distribution | |
| PI6542 | In distribution | |
| BP300 | In distribution | |
| BPS2 | In distribution | |
| PI5274 | In distribution | |
| BP300S | In distribution | |
| PI7076 | In distribution | |
| BPB01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| 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 |
| Chewies | Ortho Technology, 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.