Patterson
File, Pulp Canal, Endodontic
53manufacturers in China registered for this device type
114catalogue 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 | Patterson Dental Supply, Inc., United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-11 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 087-2077 | 6 | In distribution | |
| 087-2374 | 6 | In distribution | |
| 087-2051 | 6 | In distribution | |
| 087-2119 | 6 | In distribution | |
| 087-1863 | 6 | In distribution | |
| 087-0246 | 6 | In distribution | |
| 087-2028 | 6 | In distribution | |
| 087-1640 | 6 | In distribution | |
| 087-2820 | 6 | In distribution | |
| 087-2390 | 6 | In distribution | |
| 087-1624 | 6 | In distribution | |
| 087-2275 | 6 | In distribution | |
| 087-2804 | 6 | In distribution | |
| 087-2069 | 6 | In distribution | |
| 087-0212 | 6 | In distribution | |
| 087-1459 | 6 | In distribution | |
| 087-2010 | 6 | In distribution | |
| 087-1442 | 6 | In distribution | |
| 087-2705 | 6 | In distribution | |
| 087-2598 | 6 | In distribution | |
| 087-2408 | 6 | In distribution | |
| 087-2473 | 6 | In distribution | |
| 087-0121 | 6 | In distribution | |
| 087-2093 | 6 | In distribution | |
| 087-2283 | 6 | In distribution | |
| 087-1681 | 6 | In distribution | |
| 087-2358 | 6 | In distribution | |
| 087-2143 | 6 | In distribution | |
| 087-1889 | 6 | In distribution | |
| 084-3110 | 6 | In distribution | |
| 087-2218 | 6 | In distribution | |
| 087-0147 | 6 | In distribution | |
| 087-2465 | 6 | In distribution | |
| 084-3128 | 6 | In distribution | |
| 087-3125 | 6 | In distribution | |
| 087-2572 | 6 | In distribution | |
| 087-2416 | 6 | In distribution | |
| 084-3086 | 6 | In distribution | |
| 087-2309 | 6 | In distribution | |
| 087-2606 | 6 | In distribution | |
| 084-3094 | 6 | In distribution | |
| 087-1590 | 6 | In distribution | |
| 087-2580 | 6 | In distribution | |
| 087-2127 | 6 | In distribution | |
| 087-1665 | 6 | In distribution | |
| 087-1558 | 6 | In distribution | |
| 087-2812 | 6 | In distribution | |
| 087-2424 | 6 | In distribution | |
| 087-1616 | 6 | In distribution | |
| 087-1632 | 6 | In distribution | |
| 087-2481 | 6 | In distribution | |
| 087-2614 | 6 | In distribution | |
| 087-0220 | 6 | In distribution | |
| 087-1491 | 6 | In distribution | |
| 087-2101 | 6 | In distribution | |
| 087-1483 | 6 | In distribution | |
| 087-1954 | 6 | In distribution | |
| 087-1871 | 6 | In distribution | |
| 087-2085 | 6 | In distribution | |
| 087-2259 | 6 | In distribution | |
| 087-2267 | 6 | In distribution | |
| 087-1426 | 6 | In distribution | |
| 087-2333 | 6 | In distribution | |
| 087-2887 | 6 | In distribution | |
| 087-2176 | 6 | In distribution | |
| 087-1897 | 6 | In distribution | |
| 087-2135 | 6 | In distribution | |
| 087-1475 | 6 | In distribution | |
| 087-2366 | 6 | In distribution | |
| 087-1582 | 6 | In distribution | |
| 087-2234 | 6 | In distribution | |
| 087-2457 | 6 | In distribution | |
| 087-3091 | 6 | In distribution | |
| 087-2622 | 6 | In distribution | |
| 087-2697 | 6 | In distribution | |
| 087-3109 | 6 | In distribution | |
| 087-0238 | 6 | In distribution | |
| 087-0154 | 6 | In distribution | |
| 087-1814 | 6 | In distribution | |
| 087-2796 | 6 | In distribution | |
| 087-1541 | 6 | In distribution | |
| 087-2432 | 6 | In distribution | |
| 087-2200 | 6 | In distribution | |
| 087-2382 | 6 | In distribution | |
| 087-1434 | 6 | In distribution | |
| 087-1806 | 6 | In distribution | |
| 087-2317 | 6 | In distribution | |
| 087-2564 | 6 | In distribution | |
| 084-3102 | 6 | In distribution | |
| 087-2168 | 6 | In distribution | |
| 087-1855 | 6 | In distribution | |
| 087-1822 | 6 | In distribution | |
| 087-1848 | 6 | In distribution | |
| 087-2242 | 6 | In distribution | |
| 087-1533 | 6 | In distribution | |
| 087-2184 | 6 | In distribution | |
| 087-1467 | 6 | In distribution | |
| 087-2150 | 6 | In distribution | |
| 087-0261 | 6 | In distribution | |
| 087-2036 | 6 | In distribution | |
| 087-1830 | 6 | In distribution | |
| 087-0253 | 6 | In distribution | |
| 087-2044 | 6 | In distribution | |
| 087-2226 | 6 | In distribution | |
| 084-3136 | 6 | In distribution | |
| 087-2440 | 6 | In distribution | |
| 087-1517 | 6 | In distribution | |
| 087-2192 | 6 | In distribution | |
| 087-1418 | 6 | In distribution | |
| 087-1566 | 6 | In distribution | |
| 087-1574 | 6 | In distribution | |
| 087-1608 | 6 | In distribution | |
| 087-0139 | 6 | In distribution | |
| 087-1699 | 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.