Jizai
MANI NiTi FILES R
53manufacturers in China registered for this device type
138catalogue 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 | Mani, Inc., United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2025-03-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 030 04 31mm | 3 | In distribution | |
| 030 04 21mm | 3 | In distribution | |
| 020 04/025 04/025 06(21mm) | 3 | In distribution | |
| 025 04 25mm | 3 | In distribution | |
| 045 04 28mm | 3 | In distribution | |
| 045 04 31mm | 3 | In distribution | |
| 030 06 28mm | 3 | In distribution | |
| 040 04 31mm | 3 | In distribution | |
| 025 04 25mm | 3 | In distribution | |
| 020 04 28mm | 3 | In distribution | |
| 013 04/020 04/025 04(31mm) | 3 | In distribution | |
| 020 04 25mm | 3 | In distribution | |
| 050 04 25mm | 3 | In distribution | |
| 020 04 28mm | 3 | In distribution | |
| 035 06 28mm | 3 | In distribution | |
| 025 04 21mm | 3 | In distribution | |
| 013 04/020 04/025 04(21mm) | 3 | In distribution | |
| 050 04 25mm | 3 | In distribution | |
| 035 04 21mm | 3 | In distribution | |
| 013 04 28mm | 3 | In distribution | |
| 025 04/025 06/035 04(31mm) | 3 | In distribution | |
| 035 06 21mm | 3 | In distribution | |
| 025 06 21mm | 3 | In distribution | |
| 025 14 31mm | 3 | In distribution | |
| 020 04 31mm | 3 | In distribution | |
| 025 06 28mm | 3 | In distribution | |
| 025 04 28mm | 3 | In distribution | |
| 013 04/025 04/025 06(25mm) | 3 | In distribution | |
| 020 04/025 04/025 06(28mm) | 3 | In distribution | |
| 035 04 31mm | 3 | In distribution | |
| 035 06 31mm | 3 | In distribution | |
| 040 04 25mm | 3 | In distribution | |
| 050 04 28mm | 3 | In distribution | |
| 020 04/025 04/025 06(25mm) | 3 | In distribution | |
| 030 06 31mm | 3 | In distribution | |
| 035 06 31mm | 3 | In distribution | |
| 050 04 28mm | 3 | In distribution | |
| 013 04/020 04/025 04(31mm) | 3 | In distribution | |
| 035 06 28mm | 3 | In distribution | |
| 035 04 21mm | 3 | In distribution | |
| 020 04 21mm | 3 | In distribution | |
| 030 04 31mm | 3 | In distribution | |
| 025 14 18mm/013 04, 020 04 31mm | 3 | In distribution | |
| 025 04 31mm | 3 | In distribution | |
| 020 04 21mm | 3 | In distribution | |
| 045 04 28mm | 3 | In distribution | |
| 025 04 28mm | 3 | In distribution | |
| 013 04/020 04/025 04(28mm) | 3 | In distribution | |
| 013 04/020 04/025 04(25mm) | 3 | In distribution | |
| 045 04 21mm | 3 | In distribution | |
| 045 04 25mm | 3 | In distribution | |
| 030 04 25mm | 3 | In distribution | |
| 045 04 31mm | 3 | In distribution | |
| 035 06 25mm | 3 | In distribution | |
| 025 06 31mm | 3 | In distribution | |
| 025 14(18mm)/013 04, 020 04(28mm) | 3 | In distribution | |
| 030 06 25mm | 3 | In distribution | |
| 013 04/025 04/025 06(21mm) | 3 | In distribution | |
| 025 14(18mm)/013 04, 020 04(31mm) | 3 | In distribution | |
| 045 04 21mm | 3 | In distribution | |
| 025 06 21mm | 3 | In distribution | |
| 035 04 25mm | 3 | In distribution | |
| 025 14 28mm | 3 | In distribution | |
| 025 06 31mm | 3 | In distribution | |
| 025 14 18mm | 3 | In distribution | |
| 025 14 18mm/025 04, 025 06 21mm | 3 | In distribution | |
| 020 04/025 04/025 06(25mm) | 3 | In distribution | |
| 035 04 28mm | 3 | In distribution | |
| 025 06 25mm | 3 | In distribution | |
| 030 04 28mm | 3 | In distribution | |
| 045 04 25mm | 3 | In distribution | |
| 040 04 28mm | 3 | In distribution | |
| 035 04 28mm | 3 | In distribution | |
| 013 04/025 04/025 06(25mm) | 3 | In distribution | |
| 030 06 25mm | 3 | In distribution | |
| 030 06 28mm | 3 | In distribution | |
| 013 04/020 04/025 04(25mm) | 3 | In distribution | |
| 030 06 31mm | 3 | In distribution | |
| 020 04/025 04/025 06(28mm) | 3 | In distribution | |
| 013 04 31mm | 3 | In distribution | |
| 035 04 31mm | 3 | In distribution | |
| 025 14 25mm | 3 | In distribution | |
| 020 04 31mm | 3 | In distribution | |
| 030 06 21mm | 3 | In distribution | |
| 030 06 21mm | 3 | In distribution | |
| 013 04 31mm | 3 | In distribution | |
| 025 14 31mm | 3 | In distribution | |
| 025 04/025 06/035 04(25mm) | 3 | In distribution | |
| 020 04 25mm | 3 | In distribution | |
| 040 04 31mm | 3 | In distribution | |
| 025 06 25mm | 3 | In distribution | |
| 040 04 21mm | 3 | In distribution | |
| 013 04/025 04/025 06(21mm) | 3 | In distribution | |
| 035 06 21mm | 3 | In distribution | |
| 013 04/020 04/025 04(28mm) | 3 | In distribution | |
| 013 04 25mm | 3 | In distribution | |
| 025 14 18mm | 3 | In distribution | |
| 025 14 21mm | 3 | In distribution | |
| 025 04/025 06/035 04(21mm) | 3 | In distribution | |
| 025 14 18mm/013 04, 020 04 25mm | 3 | In distribution | |
| 050 04 31mm | 3 | In distribution | |
| 030 04 21mm | 3 | In distribution | |
| 020 04/025 04/025 06(31mm) | 3 | In distribution | |
| 013 04 21mm | 3 | In distribution | |
| 025 14 28mm | 3 | In distribution | |
| 025 14 18mm/013 04, 020 04 28mm | 3 | In distribution | |
| 013 04 21mm | 3 | In distribution | |
| 025 04/025 06/035 04(28mm) | 3 | In distribution | |
| 050 04 31mm | 3 | In distribution | |
| 040 04 21mm | 3 | In distribution | |
| 025 14 18mm/013 04, 020 04 21mm | 3 | In distribution | |
| 025 14 25mm | 3 | In distribution | |
| 025 14(18mm)/025 04,025 06(21mm) | 3 | In distribution | |
| 025 14(18mm)/013 04, 020 04(21mm) | 3 | In distribution | |
| 025 04 21mm | 3 | In distribution | |
| 020 04/025 04/025 06(21mm) | 3 | In distribution | |
| 025 14 21mm | 3 | In distribution | |
| 050 04 21mm | 3 | In distribution | |
| 050 04 21mm | 3 | In distribution | |
| 040 04 25mm | 3 | In distribution | |
| 025 04 31mm | 3 | In distribution | |
| 013 04 25mm | 3 | In distribution | |
| 030 04 28mm | 3 | In distribution | |
| 025 14(18mm)/013 04, 020 04(25mm) | 3 | In distribution | |
| 025 14 18mm/025 04, 025 06 25mm | 3 | In distribution | |
| 030 04 25mm | 3 | In distribution | |
| 020 04/025 04/025 06(31mm) | 3 | In distribution | |
| 025 04/025 06/035 04(28mm) | 3 | In distribution | |
| 013 04 28mm | 3 | In distribution | |
| 035 06 25mm | 3 | In distribution | |
| 025 04/025 06/035 04(31mm) | 3 | In distribution | |
| 025 14(18mm)/025 04,025 06(25mm) | 3 | In distribution | |
| 025 04/025 06/035 04(25mm) | 3 | In distribution | |
| 040 04 28mm | 3 | In distribution | |
| 013 04/020 04/025 04(21mm) | 3 | In distribution | |
| 025 04/025 06/035 04(21mm) | 3 | In distribution | |
| 035 04 25mm | 3 | In distribution | |
| 025 06 28mm | 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.