Premier Composite Instruments
CPF DE_TB Trico 1/2
23manufacturers in China registered for this device type
14catalogue 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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EIY |
| Device type | Instrument, Filling, Plastic, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-04-02 |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1003720 | In distribution | |
| 1003693 | In distribution | |
| 1003704 | In distribution | |
| 1003705 | In distribution | |
| 1003736 | In distribution | |
| 1003718 | In distribution | |
| 1003724 | In distribution | |
| 1003725 | In distribution | |
| 1003706 | In distribution | |
| 1003692 | In distribution | |
| 1003710 | In distribution | |
| 1003723 | In distribution | |
| 1003707 | In distribution | |
| 1003721 | 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.