Straight Shooter Plunger Assembly
Twin Bracket Plunger Kit
10manufacturers in China registered for this device type
2catalogue 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 | TP Orthodontics, Inc., United States |
|---|---|
| FDA product code | ECP |
| Device type | Instrument, Ligature Tucking, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 100-365 | In distribution | |
| 100-363 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 76 |
| 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 |
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.