ZenFlex CM
ZenFlex CM .06/21mm ASSORTED PACK US/CAN Contents: .13/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145230, Qty 1 .15/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145261, Qty 1 .17/.06/21mm…
ZenFlex CM.06/21mm ASSORTED PACK US/CAN Contents:.13/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145230, Qty 1.15/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145261, Qty 1.17/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145292, Qty 1.20/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145322, Qty 1.25/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145353, Qty 1.30/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145384, Qty 1
53manufacturers in China registered for this device type
40catalogue 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 | 2026-02-18 |
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 |
|---|---|---|---|
| 818-3510 | Size.20/Taper.04/Length 21mm | 6 | In distribution |
| 818-3618 | Size.30/Taper.06/Length 31mm | 6 | In distribution |
| 818-3517 | Size.30/.Taper 04/Length 25mm | 6 | In distribution |
| 818-3516 | Size.30/Taper.04/Length 21mm | 6 | In distribution |
| 818-3509 | Size.17/Taper.04/Length 31mm | 6 | In distribution |
| 818-3612 | Size.20/Taper.06/Length 31mm | 6 | In distribution |
| 818-3602 | Size.13/Taper.06/Length 25mm | 6 | In distribution |
| 818-3691 | Assorted sizes, Taper.06/Length 21mm | In distribution | |
| 818-3515 | Size.25/Taper.04/Length 31mm | 6 | In distribution |
| 818-3608 | Size.17/Taper.06/Length 25mm | 6 | In distribution |
| 818-3502 | Size.13/Taper.04/Length 25mm | 6 | In distribution |
| 818-3605 | Size.15/Taper.06/Length 25mm | 6 | In distribution |
| 818-3513 | Size.25/Taper.04/Length 21mm | 6 | In distribution |
| 818-3617 | Size.30/Taper.06/Length 25mm | 6 | In distribution |
| 818-3592 | Assorted sizes, Taper.04/Length 25mm | In distribution | |
| 818-3508 | Size.17/Taper.04/Length 25mm | 6 | In distribution |
| 818-3610 | Size.20/Taper.06/Length 21mm | 6 | In distribution |
| 818-3613 | Size.25/Taper.06/Length21mm | 6 | In distribution |
| 818-3611 | Size.20/Taper.06/Length 25mm | 6 | In distribution |
| 818-3503 | Size.13/Taper.04/Length 31mm | 6 | In distribution |
| 818-3505 | Size.15/Taper.04/Length 25mm | 6 | In distribution |
| 818-3501 | Size.13/Taper.04/Length 21mm | 6 | In distribution |
| 818-3506 | Size.15/Taper.04/Length31mm | 6 | In distribution |
| 818-3607 | Size.17/Taper.06/Length 21mm | 6 | In distribution |
| 818-3604 | Size.15/Taper.06/Length 21mm | 6 | In distribution |
| 818-3692 | Assorted sizes, Taper.06/Length 25mm | In distribution | |
| 818-3512 | Size.20/Taper.04/Length 31mm | 6 | In distribution |
| 818-3591 | Assorted sizes, Taper.04/Length 21mm | In distribution | |
| 818-3609 | Size.17/Taper.06/Length 31mm | 6 | In distribution |
| 818-3511 | Size.20/Taper.04/Length 25mm | 6 | In distribution |
| 818-3614 | Size.25/Taper.06/Length 25mm | 6 | In distribution |
| 818-3507 | Size.17/Taper.04/Length 21mm | 6 | In distribution |
| 818-3601 | Size.13/Taper.06/Length 21mm | 6 | In distribution |
| 818-3514 | Size.25/Taper.04/Length 25mm | 6 | In distribution |
| 818-3603 | Size.13/Taper.06/Length 31mm | 6 | In distribution |
| 818-3616 | Size.30/Taper.06/Length 21mm | 6 | In distribution |
| 818-3518 | Size.30/Taper.04/Length 31mm | 6 | In distribution |
| 818-3606 | Size.15/Taper.06/Length 31mm | 6 | In distribution |
| 818-3504 | Size.15/Taper.04/Length 21mm | 6 | In distribution |
| 818-3615 | Size.25/Taper.06/Length 31mm | 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.