Henry Schein
AIR Anodized Composit Inst. F4
23manufacturers in China registered for this device type
28catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EIY |
| Device type | Instrument, Filling, Plastic, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2019-09-17 |
| 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 |
| Storage | Special storage condition: To be stored in dry and fresh place, protected from sunlight |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1002564 | In distribution | |
| 9004796 | In distribution | |
| 1008173 | In distribution | |
| 9008092 | In distribution | |
| 1007560 | In distribution | |
| 9008065 | In distribution | |
| 1002712 | In distribution | |
| 9008093 | In distribution | |
| 1016587 | In distribution | |
| 9000790 | In distribution | |
| 9004793 | In distribution | |
| 9008086 | In distribution | |
| 9004792 | In distribution | |
| 1000270 | In distribution | |
| 9008067 | In distribution | |
| 1003073 | In distribution | |
| 9008085 | In distribution | |
| 1000087 | In distribution | |
| 1006055 | In distribution | |
| 1008645 | In distribution | |
| 1027355 | In distribution | |
| 1009795 | In distribution | |
| 9004795 | In distribution | |
| 1000085 | In distribution | |
| 9008066 | In distribution | |
| 9004797 | In distribution | |
| 1000851 | In distribution | |
| 9004794 | 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 |
| 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 |
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.