JMU
JMU NITI ROTARY FILES, VT-B UPG FILES, 01/09(19mm), 20/04, 25/04, 30/04, 35/04, 25/06(25mm), Sterilized Packing, 6pcs/Pk, #PRO-FLEXI FILES (BLUE)
53manufacturers in China registered for this device type
130catalogue 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 | JMU Dental, Inc, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2025-07-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21517006 | In distribution | |
| 21502005 | In distribution | |
| 22801006 | In distribution | |
| 21517017 | In distribution | |
| 22801036 | In distribution | |
| 22801039 | In distribution | |
| 22801034 | In distribution | |
| 21518005 | In distribution | |
| 21518006 | In distribution | |
| 21518039 | In distribution | |
| 22801017 | In distribution | |
| 21517034 | In distribution | |
| 21517009 | In distribution | |
| 22801021 | In distribution | |
| 21517004 | In distribution | |
| 22801002 | In distribution | |
| 22801029 | In distribution | |
| 22801027 | In distribution | |
| 22801012 | In distribution | |
| 21517036 | In distribution | |
| 21518038 | In distribution | |
| 22801001 | In distribution | |
| 21517030 | In distribution | |
| 21518002 | In distribution | |
| 22801047 | In distribution | |
| 21518016 | In distribution | |
| 21518010 | In distribution | |
| 21517007 | In distribution | |
| 22801019 | In distribution | |
| 22801003 | In distribution | |
| 21517016 | In distribution | |
| 21518023 | In distribution | |
| 22801030 | In distribution | |
| 21518031 | In distribution | |
| 21517028 | In distribution | |
| 21517031 | In distribution | |
| 21518014 | In distribution | |
| 21518009 | In distribution | |
| 21518015 | In distribution | |
| 21518040 | In distribution | |
| 22801023 | In distribution | |
| 22801022 | In distribution | |
| 22801041 | In distribution | |
| 22801042 | In distribution | |
| 22801016 | In distribution | |
| 21518021 | In distribution | |
| 21517024 | In distribution | |
| 21517025 | In distribution | |
| 21518037 | In distribution | |
| 21518027 | In distribution | |
| 21518041 | In distribution | |
| 21518028 | In distribution | |
| 22801004 | In distribution | |
| 21518024 | In distribution | |
| 22801013 | In distribution | |
| 21518025 | In distribution | |
| 22801018 | In distribution | |
| 22801031 | In distribution | |
| 21517035 | In distribution | |
| 21518001 | In distribution | |
| 22801014 | In distribution | |
| 21518019 | In distribution | |
| 21518011 | In distribution | |
| 21517032 | In distribution | |
| 22801040 | In distribution | |
| 21517018 | In distribution | |
| 22801038 | In distribution | |
| 22801011 | In distribution | |
| 22801037 | In distribution | |
| 21517001 | In distribution | |
| 21518033 | In distribution | |
| 21517029 | In distribution | |
| 21518036 | In distribution | |
| 22801025 | In distribution | |
| 22801024 | In distribution | |
| 22801043 | In distribution | |
| 21518003 | In distribution | |
| 22801005 | In distribution | |
| 22801044 | In distribution | |
| 21518004 | In distribution | |
| 22801009 | In distribution | |
| 21518007 | In distribution | |
| 21517022 | In distribution | |
| 21518034 | In distribution | |
| 22801028 | In distribution | |
| 21517019 | In distribution | |
| 21517033 | In distribution | |
| 21518035 | In distribution | |
| 21502003 | In distribution | |
| 22801015 | In distribution | |
| 22801032 | In distribution | |
| 21517011 | In distribution | |
| 21517013 | In distribution | |
| 22801007 | In distribution | |
| 21517027 | In distribution | |
| 21517002 | In distribution | |
| 21502004 | In distribution | |
| 21517023 | In distribution | |
| 21518012 | In distribution | |
| 21517037 | In distribution | |
| 22801033 | In distribution | |
| 21518032 | In distribution | |
| 21517026 | In distribution | |
| 21517008 | In distribution | |
| 22801045 | In distribution | |
| 21502001 | In distribution | |
| 22801008 | In distribution | |
| 21518018 | In distribution | |
| 21518020 | In distribution | |
| 21518008 | In distribution | |
| 22801046 | In distribution | |
| 22801035 | In distribution | |
| 21518017 | In distribution | |
| 21502002 | In distribution | |
| 21517012 | In distribution | |
| 21517014 | In distribution | |
| 22801026 | In distribution | |
| 22801020 | In distribution | |
| 21518029 | In distribution | |
| 21517020 | In distribution | |
| 21518013 | In distribution | |
| 21517010 | In distribution | |
| 22801010 | In distribution | |
| 21518026 | In distribution | |
| 21517015 | In distribution | |
| 21517021 | In distribution | |
| 21517005 | In distribution | |
| 21518030 | In distribution | |
| 21518022 | In distribution | |
| 21517003 | 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.