Sklar®
Scaler Octagonal Hndl DE #204S
34manufacturers in China registered for this device type
81catalogue numbers in this listing
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 | Sklar Corporation, United States |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-11-19 |
| Record revised | 2019-01-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41-640 | In distribution | |
| 49-2870 | In distribution | |
| 41-658 | In distribution | |
| 49-2683 | In distribution | |
| 49-2715 | In distribution | |
| 49-2985 | In distribution | |
| 41-733 | In distribution | |
| 49-2945 | In distribution | |
| 49-2692 | In distribution | |
| 49-2875 | In distribution | |
| 49-2800 | In distribution | |
| 49-2695 | In distribution | |
| 41-638 | In distribution | |
| 49-2705 | In distribution | |
| 49-2970 | In distribution | |
| 49-2770 | In distribution | |
| 41-761 | In distribution | |
| 49-2750 | In distribution | |
| 49-2815 | In distribution | |
| 49-2730 | In distribution | |
| 49-2920 | In distribution | |
| 49-2710 | In distribution | |
| 49-2940 | In distribution | |
| 41-604 | In distribution | |
| 49-2760 | In distribution | |
| 49-2693 | In distribution | |
| 49-2720 | In distribution | |
| 49-2835 | In distribution | |
| 49-2697 | In distribution | |
| 49-2775 | In distribution | |
| 41-654 | In distribution | |
| 49-2689 | In distribution | |
| 49-2755 | In distribution | |
| 49-2905 | In distribution | |
| 49-2950 | In distribution | |
| 41-666 | In distribution | |
| 49-2910 | In distribution | |
| 49-2810 | In distribution | |
| 49-2765 | In distribution | |
| 49-2845 | In distribution | |
| 49-2725 | In distribution | |
| 49-2830 | In distribution | |
| 49-2686 | In distribution | |
| 49-2900 | In distribution | |
| 49-2682 | In distribution | |
| 49-2696 | In distribution | |
| 41-612 | In distribution | |
| 49-2780 | In distribution | |
| 49-2990 | In distribution | |
| 49-2694 | In distribution | |
| 49-2820 | In distribution | |
| 49-2925 | In distribution | |
| 49-2681 | In distribution | |
| 49-2680 | In distribution | |
| 49-2965 | In distribution | |
| 49-2805 | In distribution | |
| 49-2955 | In distribution | |
| 41-674 | In distribution | |
| 49-2960 | In distribution | |
| 49-2980 | In distribution | |
| 49-2840 | In distribution | |
| 41-626 | In distribution | |
| 49-2700 | In distribution | |
| 49-2785 | In distribution | |
| 49-2525 | In distribution | |
| 49-2825 | In distribution | |
| 49-2975 | In distribution | |
| 49-2690 | In distribution | |
| 41-773 | In distribution | |
| 41-662 | In distribution | |
| 49-2790 | In distribution | |
| 41-709 | In distribution | |
| 49-2684 | In distribution | |
| 49-2880 | In distribution | |
| 49-2691 | In distribution | |
| 49-2930 | In distribution | |
| 41-652 | In distribution | |
| 49-2685 | In distribution | |
| 49-2687 | In distribution | |
| 49-2885 | In distribution | |
| 49-2688 | 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 |
| 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 |
| J & J Instruments | J & J Instruments, LLC | 56 |
Showing 12 of 216. All products under Scaler, Periodontic
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.