Helmut Zepf
Instrument, Filling Plastic Amalgam Plugger, FIG. 486/FILLING Instr. AS P.sample, D/E, 10RINGS, Satin Finish
23manufacturers in China registered for this device type
107catalogue numbers in this listing
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 | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EIY |
| Device type | Instrument, Filling, Plastic, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2023-12-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 24.725.71 | In distribution | |
| 26.120.11TI | In distribution | |
| 24.751.402TI | In distribution | |
| 28.110.01 | In distribution | |
| 26.123.102 | In distribution | |
| 26.200.13 | In distribution | |
| 26.122.00 | In distribution | |
| 19.516.00 | In distribution | |
| 41.751.50 | In distribution | |
| 26.120.13TI | In distribution | |
| 26.123.01 | In distribution | |
| 24.751.330TI | In distribution | |
| 24.751.176 | In distribution | |
| 24.751.327TI | In distribution | |
| 26.260.01 | In distribution | |
| 26.123.201 | In distribution | |
| KS26.479 | In distribution | |
| 24.751.177 | In distribution | |
| 24.751.319TI | In distribution | |
| 24.751.168 | In distribution | |
| 26.120.10TI | In distribution | |
| 24.751.332TI | In distribution | |
| 26.120.30TI | In distribution | |
| 19.202.00 | In distribution | |
| 19.201.21 | In distribution | |
| 24.751.531OX | In distribution | |
| 26.120.21TI | In distribution | |
| 24.751.170 | In distribution | |
| 19.201.11 | In distribution | |
| 24.751.329TI | In distribution | |
| KS26.486 | In distribution | |
| KS26.526 | In distribution | |
| 24.751.324TI | In distribution | |
| 26.260.02 | In distribution | |
| 24.751.532OX | In distribution | |
| 26.130.03 | In distribution | |
| 26.200.03 | In distribution | |
| 26.130.02 | In distribution | |
| 26.120.01TI | In distribution | |
| 26.200.02 | In distribution | |
| 28.114.00 | In distribution | |
| 24.710.01OX | In distribution | |
| 24.751.404TI | In distribution | |
| 24.751.333TI | In distribution | |
| 24.751.325TI | In distribution | |
| 24.751.322TI | In distribution | |
| 24.710.02OX | In distribution | |
| 19.201.31 | In distribution | |
| 24.751.533OX | In distribution | |
| 26.120.50TI | In distribution | |
| 24.751.167 | In distribution | |
| 26.314.01 | In distribution | |
| 24.751.401TI | In distribution | |
| KS26.536 | In distribution | |
| 26.120.40TI | In distribution | |
| 24.751.169 | In distribution | |
| 26.260.00 | In distribution | |
| 26.120.70TI | In distribution | |
| 26.120.14TI | In distribution | |
| 28.111.01 | In distribution | |
| 26.200.35 | In distribution | |
| 24.751.173 | In distribution | |
| 24.532.19 | In distribution | |
| 28.130.00 | In distribution | |
| 26.130.01 | In distribution | |
| 26.123.101 | In distribution | |
| 26.122.10 | In distribution | |
| 26.120.12TI | In distribution | |
| 26.200.36 | In distribution | |
| 26.123.202 | In distribution | |
| 26.120.60TI | In distribution | |
| 24.725.72 | In distribution | |
| KS26.574 | In distribution | |
| 24.751.320TI | In distribution | |
| 24.725.70 | In distribution | |
| 24.751.534OX | In distribution | |
| 24.725.73 | In distribution | |
| 26.120.00TI | In distribution | |
| 26.200.37 | In distribution | |
| 24.751.318TI | In distribution | |
| 26.120.122TI | In distribution | |
| 26.120.20TI | In distribution | |
| 26.200.17 | In distribution | |
| 24.751.172 | In distribution | |
| 24.751.328TI | In distribution | |
| 26.200.04 | In distribution | |
| 24.751.326TI | In distribution | |
| 26.123.02 | In distribution | |
| 26.200.18 | In distribution | |
| 24.751.331TI | In distribution | |
| 26.200.00 | In distribution | |
| KS26.480 | In distribution | |
| 41.751.49 | In distribution | |
| 26.120.322TI | In distribution | |
| 24.725.86 | In distribution | |
| 24.751.321TI | In distribution | |
| 26.200.01 | In distribution | |
| 26.120.31TI | In distribution | |
| 26.262.00 | In distribution | |
| 26.200.19 | In distribution | |
| 26.120.121TI | In distribution | |
| KS26.531 | In distribution | |
| 26.262.02 | In distribution | |
| 24.751.171 | In distribution | |
| 26.120.25TI | In distribution | |
| 24.751.403TI | In distribution | |
| 24.751.323TI | 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 |
| Reicodent | Devemed Gmbh | 91 |
| American Eagle Instruments | American Eagle Instruments | 79 |
| Stoma® | Storz AM Mark Gmbh | 77 |
| 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.