Stoma®
Composite instrument, Westcott, 115°, Ø 2,5mm-Ø 3,5mm, fig.21B
Who Else Makes It
Concentrated in Shanghai (5), Guangdong (5), Anhui (4). 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 Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Hefei Xingcheng Sanitary Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 21 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
Showing 12 of 23. All 23 manufacturers in China registered for Instrument, Filling, Plastic, Dental
Record
| Listed by | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | EIY |
| Device type | Instrument, Filling, Plastic, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
| Record revised | 2020-09-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2171.00 | In distribution | |
| 12012.10 | In distribution | |
| 2132.00 | In distribution | |
| 2061.00 | In distribution | |
| 7033.00 | In distribution | |
| 7085.00 | In distribution | |
| 2004.00 | In distribution | |
| 7124.00 | In distribution | |
| 2075.00 | In distribution | |
| 2034.00 | In distribution | |
| 2174.00 | In distribution | |
| 7086.00 | In distribution | |
| 2178.00 | In distribution | |
| 7046.00 | In distribution | |
| 12014.10 | In distribution | |
| 2045.00 | In distribution | |
| 2001.00 | In distribution | |
| 7034.00 | In distribution | |
| 2053.00 | In distribution | |
| 2047.00 | In distribution | |
| 2073.00 | In distribution | |
| 2041.00 | In distribution | |
| 7078.00 | In distribution | |
| 2003.00 | In distribution | |
| 2002.00 | In distribution | |
| 2172.00 | In distribution | |
| 2052.00 | In distribution | |
| 2029.00 | In distribution | |
| 7122.00 | In distribution | |
| 2030.00 | In distribution | |
| 2005.00 | In distribution | |
| 2130.00 | In distribution | |
| 2043.00 | In distribution | |
| 2124.00 | In distribution | |
| 2044.00 | In distribution | |
| 2125.00 | In distribution | |
| 2167.00 | In distribution | |
| 7013.21 | In distribution | |
| 2173.00 | In distribution | |
| 7048.00 | In distribution | |
| 2090.00 | In distribution | |
| 7045.00 | In distribution | |
| 7004.00 | In distribution | |
| 13312.30 | In distribution | |
| 7044.00 | In distribution | |
| 7076.00 | In distribution | |
| 7047.00 | In distribution | |
| 2169.00 | In distribution | |
| 2123.00 | In distribution | |
| 7087.00 | In distribution | |
| 12011.10 | In distribution | |
| 7003.00 | In distribution | |
| 7002.00 | In distribution | |
| 7061.00 | In distribution | |
| 2028.00 | In distribution | |
| 7081.00 | In distribution | |
| 2046.00 | In distribution | |
| 7014.21 | In distribution | |
| 12013.11 | In distribution | |
| 7077.00 | In distribution | |
| 2042.00 | In distribution | |
| 7084.00 | In distribution | |
| 7082.00 | In distribution | |
| 12014.11 | In distribution | |
| 2072.00 | In distribution | |
| 12013.10 | In distribution | |
| 2035.00 | In distribution | |
| 2170.00 | In distribution | |
| 2131.00 | In distribution | |
| 13312.00 | In distribution | |
| 12011.11 | In distribution | |
| 2033.00 | In distribution | |
| 2057.00 | In distribution | |
| 7150.01 | In distribution | |
| 2051.00 | In distribution | |
| 2071.00 | In distribution | |
| 2091.00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 355 |
| Power Dental USA | Power Dental U.S.A. Inc. | 111 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 107 |
| Reicodent | Devemed Gmbh | 91 |
| American Eagle Instruments | American Eagle Instruments | 79 |
| Zoll-Dental | Zoll-Dental | 69 |
| Aesculap | Aesculap AG | 60 |
| devemed | Devemed Gmbh | 58 |
| Osung MND | Osung MND Co., Ltd. | 57 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 41 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 38 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 34 |
Showing 12 of 109. All products under Instrument, Filling, Plastic, Dental
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.