HU-Friedy
Band pusher of 678-908 with picker of 678-909
10manufacturers in China registered for this device type
76catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Orthguide Medical Technology (Jiangsu) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 17 |
| Zhejiang Protect Medical Equipment Co., Ltd. | Anji | Zhejiang | Manufacturer | 16 |
| Zhejiang Shinye Medical Technology Corp.,Ltd | Hangzhou | Zhejiang | Manufacturer | 10 |
| Wuxi TP Orthodontics Material Co., Ltd. | Wuxi | Jiangsu | Repacker / relabeller | 9 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | ECP |
| Device type | Instrument, Ligature Tucking, 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 | 2025-03-03 (version 3) |
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 | 2024-04-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TK018 | In distribution | |
| 678-911 | In distribution | |
| PI5683 | In distribution | |
| PI7058 | In distribution | |
| PI57022 | In distribution | |
| 678-909 | In distribution | |
| LDP6 | In distribution | |
| PI8104 | In distribution | |
| PI5637 | In distribution | |
| PI5349 | In distribution | |
| LDG2 | In distribution | |
| PI6663 | In distribution | |
| PI6638 | In distribution | |
| PI9100 | In distribution | |
| PI5667 | In distribution | |
| PI5177 | In distribution | |
| PI5397 | In distribution | |
| PI5664 | In distribution | |
| LD8022 | In distribution | |
| PI6595 | In distribution | |
| PI8128 | In distribution | |
| LD1 | In distribution | |
| 678-707 | In distribution | |
| TK020S | In distribution | |
| PI5193 | In distribution | |
| PI8103 | In distribution | |
| PI5690 | In distribution | |
| 678-916 | In distribution | |
| PI5502 | In distribution | |
| PI56856 | In distribution | |
| PI7012 | In distribution | |
| PI5365 | In distribution | |
| SNLD1 | In distribution | |
| PI5659 | In distribution | |
| ADV8008 | In distribution | |
| 678-907S | In distribution | |
| PI7155 | In distribution | |
| PI5292 | In distribution | |
| PI4461 | In distribution | |
| LD16 | In distribution | |
| 678-910 | In distribution | |
| 678-901C | In distribution | |
| PI6630 | In distribution | |
| PI5636 | In distribution | |
| PLG5248 | In distribution | |
| PI5685 | In distribution | |
| PI5665 | In distribution | |
| 678-908 | In distribution | |
| PI908/909 | In distribution | |
| LDP | In distribution | |
| PI5337 | In distribution | |
| PI8127 | In distribution | |
| PI7143 | In distribution | |
| FE/LD | In distribution | |
| PI7148 | In distribution | |
| PI5133 | In distribution | |
| PI5284 | In distribution | |
| 678-907 | In distribution | |
| PLPK | In distribution | |
| 678-913 | In distribution | |
| SNLD2 | In distribution | |
| PI5501 | In distribution | |
| PI5426 | In distribution | |
| LDT | In distribution | |
| PI7094 | In distribution | |
| 678-708 | In distribution | |
| 678-706 | In distribution | |
| PI5640 | In distribution | |
| 678-905 | In distribution | |
| 678-914 | In distribution | |
| PI6590 | In distribution | |
| PI8012 | In distribution | |
| CV5180 | In distribution | |
| PI6639 | In distribution | |
| PI7125 | In distribution | |
| GK5480 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ortho Arch | Ortho Arch Company Inc | 41 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 36 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 19 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 11 |
| Leone SPA | Leone SPA | 10 |
| Power Dental USA | Power Dental U.S.A. Inc. | 9 |
| Spectrum | Ortho Arch Company Inc | 9 |
| J & J Instruments | J & J Instruments, LLC | 8 |
| General Instruments | American Orthodontics | 8 |
| Quinelato | Schobell Industrial Ltda | 8 |
| Preformed Ligature Wire | Ortho Arch Company Inc | 6 |
| Director | KLS-Martin L.P. | 6 |
Showing 12 of 89. All products under Instrument, Ligature Tucking, 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.