HyFlex CM
Hyflex CM File 08/25, 19mm 6 pk
53manufacturers in China registered for this device type
100catalogue 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 | 2023-06-22 |
| Record revised | 2024-11-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-11-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SBH8310440 | 6 | In distribution | |
| SBH831MED | 6 | In distribution | |
| SBH831SML | 6 | In distribution | |
| SBHNT8250415 | 6 | In distribution | |
| SBH8250625 | 6 | In distribution | |
| SBH8210620 | 6 | In distribution | |
| SBH8250430 | 6 | In distribution | |
| SBHNT8250425 | 6 | In distribution | |
| SBHNT8210640 | 6 | In distribution | |
| SBH821LRG | 6 | In distribution | |
| SBH8210415 | 6 | In distribution | |
| SBH825LRG | 6 | In distribution | |
| SBH825SML | 6 | In distribution | |
| SBHNT825LRG | 6 | In distribution | |
| SBH8310460 | 6 | In distribution | |
| SBHNT8250435 | 6 | In distribution | |
| SBH8210425 | 6 | In distribution | |
| SBHNT8250625 | 6 | In distribution | |
| SBH825MED | 6 | In distribution | |
| SBH8210460 | 6 | In distribution | |
| SBHGPF8311501 | 6 | In distribution | |
| SBH8250445 | 6 | In distribution | |
| SBH8190825 | 6 | In distribution | |
| SBHNT8250635 | 6 | In distribution | |
| SBHNT8210635 | 6 | In distribution | |
| SBHNT8250640 | 6 | In distribution | |
| SBH825ASST | 6 | In distribution | |
| SBH8310445 | 6 | In distribution | |
| SBH8250620 | 6 | In distribution | |
| SBH8310420 | 6 | In distribution | |
| SBHNT8210620 | 6 | In distribution | |
| SBH8310430 | 6 | In distribution | |
| SBH8310415 | 6 | In distribution | |
| SBHNT821SML | 6 | In distribution | |
| SBH8250420 | 6 | In distribution | |
| SBHGPF8211501 | 6 | In distribution | |
| SBH831LRG | 6 | In distribution | |
| SBHNT8250445 | 6 | In distribution | |
| SBH821MED | 6 | In distribution | |
| SBHNT821MED | 6 | In distribution | |
| SBHNT8210435 | 6 | In distribution | |
| SBHNT8210415 | 6 | In distribution | |
| SBHNT8250620 | 6 | In distribution | |
| SBH8310435 | 6 | In distribution | |
| SBHNT8210440 | 6 | In distribution | |
| SBHNT821LRG | 6 | In distribution | |
| SBH821ASST | 6 | In distribution | |
| SBHNT8250430 | 6 | In distribution | |
| SBHNT8250420 | 6 | In distribution | |
| SBH8310450 | 6 | In distribution | |
| SBHNT8210450 | 6 | In distribution | |
| SBHNT8250450 | 6 | In distribution | |
| SBHNT825SML | 6 | In distribution | |
| SBH8210445 | 6 | In distribution | |
| SBHNT8210420 | 6 | In distribution | |
| SBH8210450 | 6 | In distribution | |
| SBHGPF8251501 | 6 | In distribution | |
| SBH8310635 | 6 | In distribution | |
| SBH8210640 | 6 | In distribution | |
| SBH8310625 | 6 | In distribution | |
| SBH8210420 | 6 | In distribution | |
| SBHNT8250460 | 6 | In distribution | |
| SBH8250440 | 6 | In distribution | |
| SBH8310640 | 6 | In distribution | |
| SBHNT8210625 | 6 | In distribution | |
| SBH8210430 | 6 | In distribution | |
| SBH8250635 | 6 | In distribution | |
| SBHNT8210460 | 6 | In distribution | |
| SBHNT8210445 | 6 | In distribution | |
| SBHNT8210425 | 6 | In distribution | |
| SBH8210625 | 6 | In distribution | |
| SBHNT8250440 | 6 | In distribution | |
| SBHNT825MED | 6 | In distribution | |
| SBHNT8210430 | 6 | In distribution | |
| SBH8250415 | 6 | In distribution | |
| SBH8310630 | 6 | In distribution | |
| SBH821SML | 6 | In distribution | |
| SBHNT8210630 | 6 | In distribution | |
| SBH8250450 | 6 | In distribution | |
| SBH8250460 | 6 | In distribution | |
| SBH8310425 | 6 | In distribution | |
| SBH8250640 | 6 | In distribution | |
| SBH8210435 | 6 | In distribution | |
| SBH8250630 | 6 | In distribution | |
| SBH8310620 | 6 | In distribution | |
| SBH8210440 | 6 | In distribution | |
| SBHNT8250630 | 6 | In distribution | |
| SBH8210635 | 6 | In distribution | |
| SBH8250435 | 6 | In distribution | |
| SBH8250425 | 6 | In distribution | |
| SBH8210630 | 6 | In distribution | |
| SBHGPF8251502 | 6 | Withdrawn | |
| SBHGPF8312002 | 6 | Withdrawn | |
| SBHGPF821ASST | 6 | Withdrawn | |
| SBHGPF8212002 | 6 | Withdrawn | |
| SBHGPF8252002 | 6 | Withdrawn | |
| SBHGPF8211502 | 6 | Withdrawn | |
| SBHGPF831ASST | 6 | Withdrawn | |
| SBHGPF825ASST | 6 | Withdrawn | |
| SBHGPF8311502 | 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.