Premier K-Files
Files PKG 6 25MM 15-40
53manufacturers in China registered for this device type
49catalogue 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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-10-17 |
| Record revised | 2026-06-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-06-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9053299 | In distribution | |
| 9053248 | In distribution | |
| 9053296 | In distribution | |
| 9053234 | In distribution | |
| 9053240 | In distribution | |
| 9053212 | In distribution | |
| 9053218 | In distribution | |
| 9053233 | In distribution | |
| 9053209 | In distribution | |
| 9053294 | In distribution | |
| 9053203 | In distribution | |
| 9053300 | In distribution | |
| 9053301 | In distribution | |
| 9053231 | In distribution | |
| 9053239 | In distribution | |
| 9053238 | In distribution | |
| 9053311 | In distribution | |
| 9053249 | In distribution | |
| 9053241 | In distribution | |
| 9053201 | In distribution | |
| 9053298 | In distribution | |
| 9053205 | In distribution | |
| 9053237 | In distribution | |
| 9053290 | In distribution | |
| 9053291 | In distribution | |
| 9053236 | In distribution | |
| 9053207 | In distribution | |
| 9053293 | In distribution | |
| 9053312 | In distribution | |
| 9053211 | In distribution | |
| 9053304 | In distribution | |
| 9053242 | In distribution | |
| 9053219 | In distribution | |
| 9053292 | In distribution | |
| 9053295 | In distribution | |
| 9053302 | In distribution | |
| 9053232 | In distribution | |
| 9053206 | In distribution | |
| 9053297 | In distribution | |
| 9053210 | In distribution | |
| 9053208 | In distribution | |
| 9053200 | In distribution | |
| 9053235 | In distribution | |
| 9053230 | In distribution | |
| 9053202 | In distribution | |
| 9053204 | In distribution | |
| 9053303 | Withdrawn | |
| 9053243 | Withdrawn | |
| 9053244 | 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.