HyFlex EDM
HyFlex™ EDM Shaping Set Max Curve 20/0.05; 15/0.03; 10/0.05 25 mm
53manufacturers in China registered for this device type
63catalogue 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 | Coltène/Whaledent AG, Switzerland |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2024-02-14 |
| Record revised | 2025-09-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: keep dry; Special storage condition: keep away from sunlight; Storage environment temperature 2 to 25 °C; Storage environment temperature 37 to 77 °F |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 60036141 | In distribution | ||
| 60041090 | In distribution | ||
| 60019596 | 3 | In distribution | |
| 60036140 | 3 | In distribution | |
| 60022277 | In distribution | ||
| 60022282 | 3 | In distribution | |
| 60022280 | In distribution | ||
| 60023495 | In distribution | ||
| 60036142 | In distribution | ||
| 60041087 | 3 | In distribution | |
| 60022284 | 3 | In distribution | |
| 60022272 | 3 | In distribution | |
| 60022287 | 3 | In distribution | |
| 60019364 | In distribution | ||
| 60022288 | In distribution | ||
| 60022269 | 3 | In distribution | |
| 60019642 | In distribution | ||
| 60036136 | 3 | In distribution | |
| 60019641 | In distribution | ||
| 60019631 | 3 | In distribution | |
| 60019594 | 3 | In distribution | |
| 60022278 | In distribution | ||
| 60019595 | 3 | In distribution | |
| 60019597 | 3 | In distribution | |
| 60022283 | 3 | In distribution | |
| 60019598 | 3 | In distribution | |
| 60019633 | 3 | In distribution | |
| 60019629 | 3 | In distribution | |
| 60041089 | 3 | In distribution | |
| 60023492 | 3 | In distribution | |
| 60023573 | 3 | In distribution | |
| 60019632 | 3 | In distribution | |
| 60023494 | In distribution | ||
| 60023575 | In distribution | ||
| 60019599 | 3 | In distribution | |
| 60041086 | 3 | In distribution | |
| 60022286 | 3 | In distribution | |
| 60022285 | 3 | In distribution | |
| 60041085 | 3 | In distribution | |
| 60022268 | In distribution | ||
| 60019630 | 3 | In distribution | |
| 60041081 | 3 | In distribution | |
| 60036137 | 3 | In distribution | |
| 60019628 | 3 | In distribution | |
| 60022279 | In distribution | ||
| 60019363 | In distribution | ||
| 60022271 | 3 | In distribution | |
| 60036139 | 3 | In distribution | |
| 60022274 | 3 | In distribution | |
| 60022289 | In distribution | ||
| 60041088 | 3 | In distribution | |
| 60022267 | In distribution | ||
| 60023493 | 3 | In distribution | |
| 60022281 | 3 | In distribution | |
| 60022276 | 3 | In distribution | |
| 60041083 | 3 | In distribution | |
| 60022275 | 3 | In distribution | |
| 60023576 | In distribution | ||
| 60022270 | 3 | In distribution | |
| 60041082 | 3 | In distribution | |
| 60041084 | 3 | In distribution | |
| 60023574 | 3 | In distribution | |
| 60036138 | 3 | 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.