ZenFlex
Rotary Files
53manufacturers in China registered for this device type
52catalogue 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 | Kerr Corporation, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 818-2201 | .20/.06/21mm | 6 | In distribution |
| 818-1551 | .55/.04/21mm | 6 | In distribution |
| 818-2401 | .40/.06/21mm | 6 | In distribution |
| 818-2453 | .45/.06/31mm | 6 | In distribution |
| 818-1352 | .35/.04/25mm | 6 | In distribution |
| 818-1253 | .25/.04/31mm | 6 | In distribution |
| 818-1303 | .30/.04/31mm | 6 | In distribution |
| 818-2252 | .25/.06/25mm | 6 | In distribution |
| 818-2502 | .50/.06/25mm | 6 | In distribution |
| 818-1302 | .30/.04/25mm | 6 | In distribution |
| 818-2402 | .40/.06/25mm | 6 | In distribution |
| 818-1401 | .40/.04/21mm | 6 | In distribution |
| 818-1202 | .20/.04/25mm | 6 | In distribution |
| 818-1201 | .20/.04/21mm | 6 | In distribution |
| 818-2353 | .35/.06/31mm | 6 | In distribution |
| 818-1251 | .25/.04/21mm | 6 | In distribution |
| 818-1452 | .45/.04/25mm | 6 | In distribution |
| 818-2251 | .25/.06/21mm | 6 | In distribution |
| 818-2351 | .35/.06/21mm | 6 | In distribution |
| 818-2551 | .55/.06/21mm | 6 | In distribution |
| 818-2553 | .55/.06/31mm | 6 | In distribution |
| 818-0425 | .04/25mm Assorted Pack | 6 | In distribution |
| 818-1502 | .50/.04/25mm | 6 | In distribution |
| 818-1203 | .20/.04/31mm | 6 | In distribution |
| 818-2352 | .35/.06/25mm | 6 | In distribution |
| 818-2501 | .50/.06/21mm | 6 | In distribution |
| 818-2203 | .20/.06/31mm | 6 | In distribution |
| 818-0421 | .04/21mm Assorted Pack | 6 | In distribution |
| 818-2301 | .30/.06/21mm | 6 | In distribution |
| 818-2303 | .30/.06/31mm | 6 | In distribution |
| 818-2253 | .25/.06/31mm | 6 | In distribution |
| 818-2403 | .40/.06/31mm | 6 | In distribution |
| 818-1402 | .40/.04/25mm | 6 | In distribution |
| 818-0625 | .06/25mm Assorted Pack | 6 | In distribution |
| 818-2452 | .45/.06/25mm | 6 | In distribution |
| 818-1453 | .45/.04/31mm | 6 | In distribution |
| 818-1553 | .55/.04/31mm | 6 | In distribution |
| 818-1403 | .40/.04/31mm | 6 | In distribution |
| 818-2552 | .55/.06/25mm | 6 | In distribution |
| 818-1351 | .35/.04/21mm | 6 | In distribution |
| 818-1501 | .50/.04/21mm | 6 | In distribution |
| 818-1252 | .25/.04/25mm | 6 | In distribution |
| 818-1552 | .55/.04/25mm | 6 | In distribution |
| 818-1353 | .35/.04/31mm | 6 | In distribution |
| 818-2302 | .30/.06/25mm | 6 | In distribution |
| 818-2451 | .45/.06/21mm | 6 | In distribution |
| 818-2503 | .50/.06/31mm | 6 | In distribution |
| 818-2202 | .20/.06/25mm | 6 | In distribution |
| 818-1503 | .50/.04/31mm | 6 | In distribution |
| 818-1301 | .30/.04/21mm | 6 | In distribution |
| 818-1451 | .45/.04/21mm | 6 | In distribution |
| 818-0621 | .06/21mm Assorted Pack | 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.