M-Access® K-Flexofile®
27 catalogue numbers from BNCMAFL631030, listed by Maillefer Instruments Holding Sàrl, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
27catalogue 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 | Maillefer Instruments Holding Sàrl |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
| Record revised | 2025-06-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: N/A |
| Distribution end date | 2023-06-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BNCMAFL631030 | Withdrawn | |
| BNCMAFL625AST | Withdrawn | |
| BNCMAFL621040 | Withdrawn | |
| BNCMAFL618035 | Withdrawn | |
| BNCMAFL621015 | Withdrawn | |
| BNCMAFL625040 | Withdrawn | |
| BNCMAFL618025 | Withdrawn | |
| BNCMAFL618040 | Withdrawn | |
| BNCMAFL625035 | Withdrawn | |
| BNCMAFL631035 | Withdrawn | |
| BNCMAFL631AST | Withdrawn | |
| BNCMAFL621035 | Withdrawn | |
| BNCMAFL631040 | Withdrawn | |
| BNCMAFL625015 | Withdrawn | |
| BNCMAFL621025 | Withdrawn | |
| BNCMAFL618015 | Withdrawn | |
| BNCMAFL631015 | Withdrawn | |
| BNCMAFL618030 | Withdrawn | |
| BNCMAFL625020 | Withdrawn | |
| BNCMAFL618020 | Withdrawn | |
| BNCMAFL631025 | Withdrawn | |
| BNCMAFL621030 | Withdrawn | |
| BNCMAFL625025 | Withdrawn | |
| BNCMAFL621AST | Withdrawn | |
| BNCMAFL631020 | Withdrawn | |
| BNCMAFL625030 | Withdrawn | |
| BNCMAFL621020 | 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.