Premier Amalgam Carrier
Amalgam Carrier (Metal) LRG/Jumbo
6manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EKI |
| Device type | Carrier, Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-18 |
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 |
|---|---|---|
| 9062201 | In distribution | |
| 9062202 | 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 |
| Henry Schein | Henry Schein, Inc. | 17 |
| 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 |
Showing 12 of 64. All products under Carrier, Amalgam, Operative
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K781034 | 1978-06-30 |
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.