Premier Scalers
Implant Scaler Facial (Goldman Fox) 2pk
34manufacturers in China registered for this device type
36catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-03-17 |
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 |
|---|---|---|
| 1004681 | In distribution | |
| 05629 | In distribution | |
| 05692 | In distribution | |
| 9061401 | In distribution | |
| 1004686 | In distribution | |
| 05621 | In distribution | |
| 9061421 | In distribution | |
| 05625 | In distribution | |
| 1004695 | In distribution | |
| 1004688 | In distribution | |
| 05691 | In distribution | |
| 05633 | In distribution | |
| 1004680 | In distribution | |
| 05695 | In distribution | |
| 9061423 | In distribution | |
| 05690 | In distribution | |
| 05680 | In distribution | |
| 1004684 | In distribution | |
| 9061402 | In distribution | |
| 9061422 | In distribution | |
| 1004696 | In distribution | |
| 1004697 | In distribution | |
| 05684 | In distribution | |
| 9061403 | In distribution | |
| 1004689 | In distribution | |
| 05627 | In distribution | |
| 1004687 | In distribution | |
| 9061420 | In distribution | |
| 05645 | In distribution | |
| 1004693 | In distribution | |
| 05631 | In distribution | |
| 05694 | In distribution | |
| 9061400 | In distribution | |
| 05623 | In distribution | |
| 1004682 | In distribution | |
| 1004692 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| American Eagle Instruments | American Eagle Instruments | 269 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Osung MND | Osung MND Co., Ltd. | 102 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| PDT, Inc. | PDT, Inc. | 67 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
Showing 12 of 216. All products under Scaler, Periodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K781035 | 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.