Henry Schein
Amalgam Carrier SE Steel #5
6manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (2), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EKI |
| Device type | Carrier, Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-04-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: FALSE |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1006679 | In distribution | |
| 1001384 | In distribution | |
| 1004121 | In distribution | |
| 1004565 | In distribution | |
| 1004062 | In distribution | |
| 1005232 | In distribution | |
| 1000749 | In distribution | |
| 1004778 | In distribution | |
| 1004257 | In distribution | |
| 1008212 | In distribution | |
| 9004802 | In distribution | |
| 1000235 | In distribution | |
| 1003571 | In distribution | |
| 1001293 | In distribution | |
| 1002387 | In distribution | |
| 1004411 | In distribution | |
| 1000074 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 23 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 22 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 18 |
| Zoll-Dental | Zoll-Dental | 14 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 13 |
| Buffalo Dental Mfg | Buffalo Dental Manufacturing Co., Inc. | 13 |
| Power Dental USA | Power Dental U.S.A. Inc. | 9 |
| J & J Instruments | J & J Instruments, LLC | 9 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 6 |
| Health-Tec/DHP Amalgam Carriers | Dental Health Products Inc | 6 |
| Osung MND | Osung MND Co., Ltd. | 5 |
| PDT, Inc. | PDT, Inc. | 4 |
Showing 12 of 64. All products under Carrier, Amalgam, Operative
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.