Safco Maxim K Files and Hedstrom
Safco Maxim K-Files #15-40 asst 31mm
53manufacturers in China registered for this device type
82catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (13), Jiangsu (8), Shanghai (7). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Wuhu Guli Ortho Co., Ltd. | Wuhu | Anhui | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 53. All 53 manufacturers in China registered for File, Pulp Canal, Endodontic
Record
| Listed by | Safco Dental Supply, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-06-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1027110 | 6 | In distribution | |
| 1027104 | 6 | In distribution | |
| 1026731 | 6 | In distribution | |
| 1026812 | 6 | In distribution | |
| 1027226 | 6 | In distribution | |
| 1027270 | 6 | In distribution | |
| 1027116 | 6 | In distribution | |
| 1026847 | 6 | In distribution | |
| 1027168 | 6 | In distribution | |
| 1026859 | 6 | In distribution | |
| 1027191 | 6 | In distribution | |
| 1027125 | 6 | In distribution | |
| 1027162 | 6 | In distribution | |
| 1026940 | 6 | In distribution | |
| 1026966 | 6 | In distribution | |
| 1027243 | 6 | In distribution | |
| 1026791 | 6 | In distribution | |
| 1026841 | 6 | In distribution | |
| 1026853 | 6 | In distribution | |
| 1026803 | 6 | In distribution | |
| 1027276 | 6 | In distribution | |
| 1026767 | 6 | In distribution | |
| 1027131 | 6 | In distribution | |
| 1027149 | 6 | In distribution | |
| 1026754 | 6 | In distribution | |
| 1026760 | 6 | In distribution | |
| 1026748 | 6 | In distribution | |
| 1026836 | 6 | In distribution | |
| 1027208 | 6 | In distribution | |
| 1026742 | 6 | In distribution | |
| 1027258 | 6 | In distribution | |
| 1027281 | 6 | In distribution | |
| 1026922 | 6 | In distribution | |
| 1026719 | 6 | In distribution | |
| 1026785 | 6 | In distribution | |
| 1026984 | 6 | In distribution | |
| 1027220 | 6 | In distribution | |
| 1026997 | 6 | In distribution | |
| 1027214 | 6 | In distribution | |
| 1026713 | 6 | In distribution | |
| 1026961 | 6 | In distribution | |
| 1026736 | 6 | In distribution | |
| 1027174 | 6 | In distribution | |
| 1027255 | 6 | In distribution | |
| 1026707 | 6 | In distribution | |
| 1026934 | 6 | In distribution | |
| 1026988 | 6 | In distribution | |
| 1026779 | 6 | In distribution | |
| 1026945 | 6 | In distribution | |
| 1026979 | 6 | In distribution | |
| 1026973 | 6 | In distribution | |
| 1027180 | 6 | In distribution | |
| 1027143 | 6 | In distribution | |
| 1027288 | 6 | In distribution | |
| 1026725 | 6 | In distribution | |
| 1027194 | 6 | In distribution | |
| 1026883 | 6 | In distribution | |
| 1027293 | 6 | In distribution | |
| 1026865 | 6 | In distribution | |
| 1027137 | 6 | In distribution | |
| 1027231 | 6 | In distribution | |
| 1027264 | 6 | In distribution | |
| 1026916 | 6 | In distribution | |
| 1027185 | 6 | In distribution | |
| 1026993 | 6 | In distribution | |
| 1026877 | 6 | In distribution | |
| 1026928 | 6 | In distribution | |
| 1026889 | 6 | In distribution | |
| 1026701 | 6 | In distribution | |
| 1026871 | 6 | In distribution | |
| 1026773 | 6 | In distribution | |
| 1027156 | 6 | In distribution | |
| 1027237 | 6 | In distribution | |
| 1026806 | 6 | In distribution | |
| 1026910 | 6 | In distribution | |
| 1026704 | 6 | In distribution | |
| 1026970 | 6 | In distribution | |
| 1027249 | 6 | In distribution | |
| 1026830 | 6 | In distribution | |
| 1026895 | 6 | In distribution | |
| 1026824 | 6 | In distribution | |
| 1026818 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 720 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 658 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 612 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 526 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 456 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 283 |
| Avalon Biomed | Shenzhen Denco Medical Co., Ltd. | 233 |
| KP | Guilin Kevin Peter Technology Co., Ltd. | 216 |
| Dctaper | SS White Burs LLC | 205 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 205 |
| Edge File | US Endodontics, LLC | 202 |
| Komet Root Canal Files | Gebr. Brasseler Gmbh & Co. KG | 199 |
Showing 12 of 1,536. All products under File, Pulp Canal, Endodontic
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.