Channels
Channels Flex Assorted Pack 31mm .06 Taperx.06 (x=35,40,45,50)
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 | Henry Schein, Inc., 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 | 2022-08-05 |
| Record revised | 2018-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Outer diameter 0.06 to 0.7 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2020621 | 60 | In distribution | |
| 2020117 | Outer Diameter 0.4 mm | 6 | In distribution |
| 2020585 | 4 | In distribution | |
| 2020565 | 4 | In distribution | |
| 2020581 | 4 | In distribution | |
| 2020570 | 4 | In distribution | |
| 2020531 | 4 | In distribution | |
| 2020122 | Outer Diameter 0.55 mm | 6 | In distribution |
| 2020141 | Outer Diameter 0.7 mm | 6 | In distribution |
| 2020074 | Outer Diameter 0.15 mm | 6 | In distribution |
| 2020072 | Outer Diameter 0.08 mm | 6 | In distribution |
| 2020508 | 3 | In distribution | |
| 2020576 | 4 | In distribution | |
| 2020145 | 6 | In distribution | |
| 2020540 | 4 | In distribution | |
| 2020526 | 4 | In distribution | |
| 2020573 | 4 | In distribution | |
| 2020113 | Outer Diameter 0.2 mm | 6 | In distribution |
| 2020535 | 4 | In distribution | |
| 2020523 | 4 | In distribution | |
| 2020583 | 4 | In distribution | |
| 2020529 | 4 | In distribution | |
| 2020093 | Outer Diameter 0.15 mm | 6 | In distribution |
| 2020537 | 4 | In distribution | |
| 2020502 | 4 | In distribution | |
| 2020542 | 4 | In distribution | |
| 2020501 | 4 | In distribution | |
| 2020577 | 4 | In distribution | |
| 2020513 | 3 | In distribution | |
| 2020539 | 4 | In distribution | |
| 2020076 | Outer Diameter 0.25 mm | 6 | In distribution |
| 2020587 | 4 | In distribution | |
| 2020524 | 4 | In distribution | |
| 2020078 | Outer Diameter 0.35 mm | 6 | In distribution |
| 2020102 | Outer Diameter 0.55 mm | 6 | In distribution |
| 2020575 | 4 | In distribution | |
| 2020556 | 4 | In distribution | |
| 2020137 | Outer Diameter 0.45 mm | 6 | In distribution |
| 2020500 | 4 | In distribution | |
| 2020115 | Outer Diameter 0.3 mm | 6 | In distribution |
| 2020534 | 4 | In distribution | |
| 2020126 | Outer Diameter 0.1 mm | 6 | In distribution |
| 2020139 | Outer Diameter 0.55 mm | 6 | In distribution |
| 2020579 | 4 | In distribution | |
| 2020586 | 4 | In distribution | |
| 2020530 | 4 | In distribution | |
| 2020123 | Outer Diameter 0.6 mm | 6 | In distribution |
| 2020511 | 3 | In distribution | |
| 2020532 | 4 | In distribution | |
| 2020112 | Outer Diameter 0.15 mm | 6 | In distribution |
| 2020514 | 3 | In distribution | |
| 2020131 | Outer Diameter 0.3 mm | 6 | In distribution |
| 2020580 | 4 | In distribution | |
| 2020090 | Outer Diameter 0.06 mm | 6 | In distribution |
| 2020548 | 4 | In distribution | |
| 2020518 | 4 | In distribution | |
| 2020136 | 6 | In distribution | |
| 2020092 | Outer Diameter 0.1 mm | 6 | In distribution |
| 2020553 | 4 | In distribution | |
| 2020562 | 4 | In distribution | |
| 2020504 | 3 | In distribution | |
| 2020075 | Outer Diameter 0.2 mm | 6 | In distribution |
| 2020503 | 3 | In distribution | |
| 2020130 | Outer Diameter 0.25 mm | 6 | In distribution |
| 2020085 | Outer Diameter 0.7 mm | 6 | In distribution |
| 2020578 | 4 | In distribution | |
| 2020103 | Outer Diameter 0.6 mm | 6 | In distribution |
| 2020538 | 4 | In distribution | |
| 2020510 | 3 | In distribution | |
| 2020561 | 4 | In distribution | |
| 2020571 | 4 | In distribution | |
| 2020563 | 4 | In distribution | |
| 2020517 | 4 | In distribution | |
| 2020104 | Outer Diameter 0.7 mm | 6 | In distribution |
| 2020527 | 4 | In distribution | |
| 2020572 | 4 | In distribution | |
| 2020100 | Outer Diameter 0.45 mm | 6 | In distribution |
| 2020574 | 4 | In distribution | |
| 2020507 | 3 | In distribution | |
| 2020114 | Outer Diameter 0.25 mm | 6 | In distribution |
| 2020098 | Outer Diameter 0.4 mm | 6 | In distribution |
| 2020094 | Outer Diameter 0.2 mm | 6 | In distribution |
| 2020564 | 4 | In distribution | |
| 2020506 | 3 | In distribution | |
| 2020528 | 4 | In distribution | |
| 2020118 | 6 | In distribution | |
| 2020536 | 4 | In distribution | |
| 2020081 | Outer Diameter 0.45 mm | 6 | In distribution |
| 2020083 | Outer Diameter 0.55 mm | 6 | In distribution |
| 2020079 | Outer Diameter 0.4 mm | 6 | In distribution |
| 2020525 | 4 | In distribution | |
| 2020555 | 4 | In distribution | |
| 2020505 | 3 | In distribution | |
| 2020566 | 4 | In distribution | |
| 2020520 | 4 | In distribution | |
| 2020519 | 4 | In distribution | |
| 2020097 | Outer Diameter 0.35 mm | 6 | In distribution |
| 2020509 | 3 | In distribution | |
| 2020073 | Outer Diameter 0.1 mm | 6 | In distribution |
| 2020551 | 4 | In distribution | |
| 2020129 | Outer Diameter 0.2 mm | 6 | In distribution |
| 2020550 | 4 | In distribution | |
| 2020516 | 4 | In distribution | |
| 2020521 | 4 | In distribution | |
| 2020138 | Outer Diameter 0.5 mm | 6 | In distribution |
| 2020533 | 4 | In distribution | |
| 2020541 | 4 | In distribution | |
| 2020095 | Outer Diameter 0.25 mm | 6 | In distribution |
| 2020099 | 6 | In distribution | |
| 2020111 | Outer Diameter 0.1 mm | 6 | In distribution |
| 2020140 | Outer Diameter 0.6 mm | 6 | In distribution |
| 2020549 | 4 | In distribution | |
| 2020124 | Outer Diameter 0.7 mm | 6 | In distribution |
| 2020134 | Outer Diameter 0.35 mm | 6 | In distribution |
| 2020125 | 6 | In distribution | |
| 2020084 | Outer Diameter 0.6 mm | 6 | In distribution |
| 2020121 | Outer Diameter 0.5 mm | 6 | In distribution |
| 2020116 | Outer Diameter 0.35 mm | 6 | In distribution |
| 2020559 | 4 | In distribution | |
| 2020096 | Outer Diameter 0.3 mm | 6 | In distribution |
| 2020584 | 4 | In distribution | |
| 2020135 | Outer Diameter 0.4 mm | 6 | In distribution |
| 2020091 | Outer Diameter 0.08 mm | 6 | In distribution |
| 2020101 | Outer Diameter 0.5 mm | 6 | In distribution |
| 2020082 | Outer Diameter 0.5 mm | 6 | In distribution |
| 2020554 | 4 | In distribution | |
| 2020582 | 4 | In distribution | |
| 2020071 | Outer Diameter 0.06 mm | 6 | In distribution |
| 2020080 | 6 | In distribution | |
| 2020512 | 3 | In distribution | |
| 2020522 | 4 | In distribution | |
| 2020119 | Outer Diameter 0.45 mm | 6 | In distribution |
| 2020077 | Outer Diameter 0.3 mm | 6 | In distribution |
| 2020560 | 4 | In distribution | |
| 2020544 | 4 | In distribution | |
| 2020557 | 4 | In distribution | |
| 2020515 | 4 | In distribution | |
| 2020127 | Outer Diameter 0.15 mm | 6 | In distribution |
| 2020552 | 4 | In distribution | |
| 2020543 | 4 | 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.