DM
5 pieces
53manufacturers in China registered for this device type
148catalogue 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 | Guilin Kevin Peter Technology Co., Ltd., China |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-12-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KP-1506-31 | In distribution | |
| KP-4004-25 | In distribution | |
| KP-2004-21 | In distribution | |
| KP-3506-31 | In distribution | |
| KP-E5-31 | In distribution | |
| KP-1708-19 | In distribution | |
| KP-E5-31 | In distribution | |
| KP-3504-31 | In distribution | |
| KP-12vt-25 | In distribution | |
| KP-E1-31 | In distribution | |
| KP-2006-21 | In distribution | |
| KP-2004-31 | In distribution | |
| KP-1302-21 | In distribution | |
| KP-4004-25 | In distribution | |
| KP-5004-21 | In distribution | |
| KP-1902-21 | In distribution | |
| KP-2506-25 | In distribution | |
| KP-3506-31 | In distribution | |
| KP-3006-25 | In distribution | |
| KP-E2-31 | In distribution | |
| KP-3006-25 | In distribution | |
| KP-E0-19,KP-E1-25,KP-E2-25, KP-E3-25,KP-E4-25,KP-E5-25 | In distribution | |
| KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25 | In distribution | |
| KP-E3-31 | In distribution | |
| KP-1902-31 | In distribution | |
| KP-1302-31 | In distribution | |
| KP-1708-19 KP-16vt-21 KP-2004-21 KP-2504-21 KP-2506-21 | In distribution | |
| KP-1602-31 | In distribution | |
| KP-2506-31 | In distribution | |
| KP-3006-31 | In distribution | |
| KP-1708-19 | In distribution | |
| KP-E2-25 | In distribution | |
| KP-E5-21 | In distribution | |
| KP-1506-21 | In distribution | |
| KP-2504-31 | In distribution | |
| KP-1704-31 | In distribution | |
| KP-3506-21 | In distribution | |
| KP-3504-21 | In distribution | |
| KP-E2-21 | In distribution | |
| KP-3006-21 | In distribution | |
| KP-2004-31 | In distribution | |
| KP-1708-19 KP-16vt-25 KP-2004-25 KP-2504-25 KP-2506-25 | In distribution | |
| KP-1302-25 | In distribution | |
| KP-1902-25 | In distribution | |
| KP-E4-25 | In distribution | |
| KP-3504-31 | In distribution | |
| KP-1602-21 | In distribution | |
| KP-3506-21 | In distribution | |
| KP-1704-31 | In distribution | |
| KP-16vt-31 | In distribution | |
| KP-2004-25 | In distribution | |
| KP-2504-25 | In distribution | |
| KP-3004-31 | In distribution | |
| KP-4004-31 | In distribution | |
| KP-1302-21 | In distribution | |
| KP-3004-25 | In distribution | |
| KP-2506-25 | In distribution | |
| KP-E5-25 | In distribution | |
| KP-1902-21 | In distribution | |
| KP-5004-25 | In distribution | |
| KP-2506-21 | In distribution | |
| KP-3006-21 | In distribution | |
| KP-E1-21 | In distribution | |
| KP-1602-25 | In distribution | |
| KP-4004-21 | In distribution | |
| KP-2004-21 | In distribution | |
| KP-1704-21 | In distribution | |
| KP-1902-25 | In distribution | |
| KP-E1-25 | In distribution | |
| KP-2006-25 | In distribution | |
| KP-2006-21 | In distribution | |
| KP-1602-25 | In distribution | |
| KP-E0-19 | In distribution | |
| KP-E3-25 | In distribution | |
| KP-3506-25 | In distribution | |
| KP-E1-25 | In distribution | |
| KP-2006-25 | In distribution | |
| KP-1506-31 | In distribution | |
| KP-2004-25 | In distribution | |
| KP-16vt-31 | In distribution | |
| KP-E0-19 KP-E1-25 KP-E2-25 KP-E3-25 KP-E4-25 KP-E5-25 | In distribution | |
| KP-1708-19 KP-16vt-31 KP-2004-31 KP-2504-31 KP-2506-31 | In distribution | |
| KP-E4-31 | In distribution | |
| KP-E0-19 KP-E1-31 KP-E2-31 KP-E3-31 KP-E4-31 KP-E5-31 | In distribution | |
| KP-E3-21 | In distribution | |
| KP-2504-21 | In distribution | |
| KP-12vt-31 | In distribution | |
| KP-E3-21 | In distribution | |
| KP-5004-31 | In distribution | |
| KP-1302-25 | In distribution | |
| KP-3004-21 | In distribution | |
| KP-1704-25 | In distribution | |
| KP-1506-25 | In distribution | |
| KP-E5-25 | In distribution | |
| KP-2504-21 | In distribution | |
| KP-1704-25 | In distribution | |
| KP-2504-25 | In distribution | |
| KP-5004-21 | In distribution | |
| KP-E5-21 | In distribution | |
| KP-E0-19 | In distribution | |
| KP-1704-21 | In distribution | |
| KP-12vt-31 | In distribution | |
| KP-1708-19 KP-16vt-31 KP-2004-31 KP-2504-31 KP-2506-31 | In distribution | |
| KP-E0-19,KP-E1-21,KP-E2-21, KP-E3-21,KP-E4-21,KP-E5-21 | In distribution | |
| KP-1302-31 | In distribution | |
| KP-1506-21 | In distribution | |
| KP-12vt-25 | In distribution | |
| KP-E1-21 | In distribution | |
| KP-E4-25 | In distribution | |
| KP-16vt-25 | In distribution | |
| KP-2006-31 | In distribution | |
| KP-3004-21 | In distribution | |
| KP-5004-25 | In distribution | |
| KP-3004-25 | In distribution | |
| KP-4004-21 | In distribution | |
| KP-E3-31 | In distribution | |
| KP-E2-31 | In distribution | |
| KP-E4-21 | In distribution | |
| KP-1602-21 | In distribution | |
| KP-1902-31 | In distribution | |
| KP-3504-25 | In distribution | |
| KP-3504-21 | In distribution | |
| KP-3504-25 | In distribution | |
| KP-E0-19,KP-E1-31,KP-E2-31, KP-E3-31,KP-E4-31,KP-E5-31 | In distribution | |
| KP-3506-25 | In distribution | |
| KP-E2-21 | In distribution | |
| KP-12vt-21 | In distribution | |
| KP-5004-31 | In distribution | |
| KP-E0-19 KP-E1-21 KP-E2-21 KP-E3-21 KP-E4-21 KP-E5-21 | In distribution | |
| KP-E3-25 | In distribution | |
| KP-2504-31 | In distribution | |
| KP-4004-31 | In distribution | |
| KP-16vt-21 | In distribution | |
| KP-12vt-21 | In distribution | |
| KP-1602-31 | In distribution | |
| KP-2006-31 | In distribution | |
| KP-1506-25 | In distribution | |
| KP-2506-21 | In distribution | |
| KP-3006-31 | In distribution | |
| KP-E1-31 | In distribution | |
| KP-3004-31 | In distribution | |
| KP-E4-31 | In distribution | |
| KP-E2-25 | In distribution | |
| KP-1708-19 KP-16vt-21 KP-2004-21 KP-2504-21 KP-2506-21 | In distribution | |
| KP-16vt-21 | In distribution | |
| KP-E4-21 | In distribution | |
| KP-2506-31 | In distribution | |
| KP-16vt-25 | 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.