Hyflex
Hyflex CM 06/20 x 31mm File - X-Tra Spirals
53manufacturers in China registered for this device type
160catalogue 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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
| Record revised | 2025-02-04 (version 2) |
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 |
| Distribution end date | 2025-02-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H8INTROKIT | 6 | In distribution | |
| HNT8250420 | 6 | In distribution | |
| HNT8190825 | 6 | In distribution | |
| HNT8210635 | 6 | In distribution | |
| H8250460 | 6 | In distribution | |
| H8310640 | 6 | In distribution | |
| HGPF8312002 | 6 | In distribution | |
| HGPF825ASST | 6 | In distribution | |
| HNT8310460 | 6 | In distribution | |
| 60018445 | 6 | In distribution | |
| H825ASST | 6 | In distribution | |
| HNT8250445 | 6 | In distribution | |
| HNT8250425 | 6 | In distribution | |
| HNT821LRG | 6 | In distribution | |
| HNT8310440 | 6 | In distribution | |
| H8210435 | 6 | In distribution | |
| H8310445 | 6 | In distribution | |
| 60018442 | 6 | In distribution | |
| H8310460 | 6 | In distribution | |
| H8210635 | 6 | In distribution | |
| HNT8310625 | 6 | In distribution | |
| H831MED | 6 | In distribution | |
| H8310450 | 6 | In distribution | |
| H8210620 | 6 | In distribution | |
| H8250450 | 6 | In distribution | |
| HNT825SML | 6 | In distribution | |
| H831LRG | 6 | In distribution | |
| H8210445 | 6 | In distribution | |
| HNT8210630 | 6 | In distribution | |
| HNT8310635 | 6 | In distribution | |
| HNT8210445 | 6 | In distribution | |
| HNT8250620 | 6 | In distribution | |
| HNT8310415 | 6 | In distribution | |
| HNT8250450 | 6 | In distribution | |
| HGPF8252002 | 6 | In distribution | |
| HGPF8211501 | 6 | In distribution | |
| H8250425 | 6 | In distribution | |
| HGPF821ASST | 6 | In distribution | |
| H8310425 | 6 | In distribution | |
| H8250435 | 6 | In distribution | |
| HNT8210450 | 6 | In distribution | |
| HNT8250440 | 6 | In distribution | |
| H8210625 | 6 | In distribution | |
| HNT8250460 | 6 | In distribution | |
| HNT8310640 | 6 | In distribution | |
| H8310435 | 6 | In distribution | |
| HNT831SML | 6 | In distribution | |
| H8310620 | 6 | In distribution | |
| HNT821SML | 6 | In distribution | |
| HNT8250435 | 6 | In distribution | |
| 60018460 | 6 | In distribution | |
| HNT8210415 | 6 | In distribution | |
| H831SML | 6 | In distribution | |
| H8210640 | 6 | In distribution | |
| HGPF8311501 | 6 | In distribution | |
| HNT831MED | 6 | In distribution | |
| HNT8210620 | 6 | In distribution | |
| H8250445 | 6 | In distribution | |
| H8190825 | 6 | In distribution | |
| HNT8310445 | 6 | In distribution | |
| H825LRG | 6 | In distribution | |
| 60018441 | 6 | In distribution | |
| HNT8210460 | 6 | In distribution | |
| HNT825MED | 6 | In distribution | |
| HNT8210640 | 6 | In distribution | |
| H8250625 | 6 | In distribution | |
| HNT8310435 | 6 | In distribution | |
| H8250440 | 6 | In distribution | |
| 60018446 | 6 | In distribution | |
| H8210450 | 6 | In distribution | |
| H8210460 | 6 | In distribution | |
| HNT8210420 | 6 | In distribution | |
| H8190825 | 6 | In distribution | |
| H8250620 | 6 | In distribution | |
| HNT8250635 | 6 | In distribution | |
| H8210415 | 6 | In distribution | |
| HNT8210425 | 6 | In distribution | |
| H8250630 | 6 | In distribution | |
| HNT8250630 | 6 | In distribution | |
| H8310440 | 6 | In distribution | |
| H8210420 | 6 | In distribution | |
| HGPF8211502 | 6 | In distribution | |
| HNT8250415 | 6 | In distribution | |
| HNT8310630 | 6 | In distribution | |
| H8310625 | 6 | In distribution | |
| H8210430 | 6 | In distribution | |
| H8250430 | 6 | In distribution | |
| HNT8310430 | 6 | In distribution | |
| H8310415 | 6 | In distribution | |
| H8250415 | 6 | In distribution | |
| H8210440 | 6 | In distribution | |
| HGPF831ASST | 6 | In distribution | |
| HGPF8311502 | 6 | In distribution | |
| HNT8210625 | 6 | In distribution | |
| HNT825LRG | 6 | In distribution | |
| HNT8310425 | 6 | In distribution | |
| H08438 | 6 | In distribution | |
| HNT8210435 | 6 | In distribution | |
| H821MED | 6 | In distribution | |
| H821SML | 6 | In distribution | |
| HNT8210430 | 6 | In distribution | |
| H821LRG | 6 | In distribution | |
| H8250635 | 6 | In distribution | |
| H8310630 | 6 | In distribution | |
| H8250420 | 6 | In distribution | |
| H8250640 | 6 | In distribution | |
| HGPF8251501 | 6 | In distribution | |
| HGPF8251502 | 6 | In distribution | |
| HNT821MED | 6 | In distribution | |
| H8210425 | 6 | In distribution | |
| H8210630 | 6 | In distribution | |
| 60018455 | 6 | In distribution | |
| H825SML | 6 | In distribution | |
| HNT8310420 | 6 | In distribution | |
| HNT8250625 | 6 | In distribution | |
| HGPF8212002 | 6 | In distribution | |
| H8310430 | 6 | In distribution | |
| 60018443 | 6 | In distribution | |
| HNT831LRG | 6 | In distribution | |
| H821ASST | 6 | In distribution | |
| H825MED | 6 | In distribution | |
| H8310635 | 6 | In distribution | |
| 60018444 | 6 | In distribution | |
| HNT8250640 | 6 | In distribution | |
| HNT8250430 | 6 | In distribution | |
| H8310420 | 6 | In distribution | |
| HNT8310620 | 6 | In distribution | |
| HNT8210440 | 6 | In distribution | |
| H08394 | 6 | Withdrawn | |
| H08413 | 6 | Withdrawn | |
| H08390 | 6 | Withdrawn | |
| H08387 | 6 | Withdrawn | |
| H08400 | 6 | Withdrawn | |
| H08392 | 6 | Withdrawn | |
| H08408 | 6 | Withdrawn | |
| H08414 | 6 | Withdrawn | |
| H08410 | 6 | Withdrawn | |
| H08385 | 6 | Withdrawn | |
| H08398 | 6 | Withdrawn | |
| H08384 | 6 | Withdrawn | |
| H08374 | 6 | Withdrawn | |
| H08412 | 6 | Withdrawn | |
| H08411 | 6 | Withdrawn | |
| H08391 | 6 | Withdrawn | |
| H08382 | 6 | Withdrawn | |
| H08407 | 6 | Withdrawn | |
| H08393 | 6 | Withdrawn | |
| H08404 | 6 | Withdrawn | |
| H08389 | 6 | Withdrawn | |
| H08396 | 6 | Withdrawn | |
| H08409 | 6 | Withdrawn | |
| H08372 | 6 | Withdrawn | |
| H08376 | 6 | Withdrawn | |
| H08380 | 6 | Withdrawn | |
| H08402 | 6 | Withdrawn | |
| H08378 | 6 | Withdrawn | |
| H08388 | 6 | Withdrawn | |
| H08386 | 6 | Withdrawn | |
| H08406 | 6 | Withdrawn | |
| H08371 | 6 | Withdrawn |
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.