Denco
21mm Roll Wave Assorted
53manufacturers in China registered for this device type
87catalogue 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 | Shenzhen Denco Medical Co., Ltd., China |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-12-27 |
| Record revised | 2025-06-23 (version 3) |
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, serial number |
| Distribution end date | 2024-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25mm Niti K file(For hand) #10 | In distribution | |
| 25mm PASTE CARRIERS #25-40 | In distribution | |
| 21mm Barbed broaches #3 | In distribution | |
| 25mm PASTE CARRIERS #25 | In distribution | |
| 21mm Barbed broaches #1 | In distribution | |
| 21mm Niti K file(For hand) #70 | In distribution | |
| 21mm Barbed broaches #4 | In distribution | |
| 21mm Barbed broaches #0-6 | In distribution | |
| 21mm Barbed broaches #0 | In distribution | |
| 21mm Barbed broaches #2 | In distribution | |
| 31mm D-Shaper Assorted | Withdrawn | |
| 25mm Super fileIII(Engine) F2 | Withdrawn | |
| 31mm Only One Files Blue R40 | Withdrawn | |
| 31mm Roll Wave 35/6% Medium 4pcs/pack | Withdrawn | |
| 25mm D-Super file(Engine) SX-F3 | Withdrawn | |
| 25mm Stainless Steel K-FILES (Hand Use) #15 | Withdrawn | |
| 25mm Stainless Steel K-FILES (Hand Use) #08 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #15 | Withdrawn | |
| 31mm Super fileIII(Engine) S1 | Withdrawn | |
| 21mm Super fileIII(Engine) F1 | Withdrawn | |
| 25mm Pro-Flexi Files(Heat Activation) Assorted | Withdrawn | |
| 25mm Only One Files Blue R25 | Withdrawn | |
| 25mm Super fileIII(Engine) F1 | Withdrawn | |
| 25mm Stainless Steel K-FILES(Hand Use) #20 | Withdrawn | |
| 21mm Super fileIII(Engine) F5 | Withdrawn | |
| 31mm Super fileIII(Engine) SX-F3 | Withdrawn | |
| 31mm Only One Files Blue R50 | Withdrawn | |
| 25mm Roll Wave 20/7%Small 4pcs/pack | Withdrawn | |
| Only One File Blue 25mm #25-#50 | Withdrawn | |
| 21mm Super fileIII(Engine) F3 | Withdrawn | |
| Barbed Broaches 21mm #6 | Withdrawn | |
| 21mm Super fileIII(Engine) S2 | Withdrawn | |
| 25mm Super fileIII(Engine) F5 | Withdrawn | |
| Micro Scope H Files #15-40 | Withdrawn | |
| 21mm Only One Files Blue R25 | Withdrawn | |
| 25mm Roll Wave 35/6% Medium 4pcs/pack | Withdrawn | |
| 25mm Roll Wave 25/7%Primary 4pcs/pack | Withdrawn | |
| 25mm Stainless Steel K-FILES (Hand Use) #06 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #20 | Withdrawn | |
| 31mm Super fileIII(Engine) S2 | Withdrawn | |
| Micro Scope K Files #15-40 | Withdrawn | |
| 25mm Super fileIII(Engine) F4 | Withdrawn | |
| Super Files III 25mm SX-F3 | Withdrawn | |
| Barbed Broaches 21mm #5 | Withdrawn | |
| 31mm D-Super file(Engin) SX-F3 | Withdrawn | |
| 31mm Pro-Flexi Files(Heat Activation) Assorted | Withdrawn | |
| 31mm PRO-PATH #016 | Withdrawn | |
| 21mm Super fileIII(Engine) F4 | Withdrawn | |
| 25mm C+ FILES #6-10 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #25 | Withdrawn | |
| 25mm Niti K file(For hand) #45-80 | Withdrawn | |
| 21mm Only One Files Blue R50 | Withdrawn | |
| 21mm Super fileIII(Engine) S1 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #08 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #10 | Withdrawn | |
| 31mm Super fileIII(Engine) F3 | Withdrawn | |
| 21mm Niti K file(For hand) #35 | Withdrawn | |
| 25mm PRO-PATH #016 | Withdrawn | |
| 25mm Stainless Steel K-FILES(Hand Use) #25 | Withdrawn | |
| 25mm Super fileIII(Engine) S1 | Withdrawn | |
| 31mm Super fileIII(Engine) F1 | Withdrawn | |
| 21mm Pro-Flexi Files(Heat Activation) Assorted | Withdrawn | |
| 25mm Only One Files Blue R50 | Withdrawn | |
| 31mm Roll Wave Assorted | Withdrawn | |
| 21mm Super fileIII(Engine) F2 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #06 | Withdrawn | |
| 31mm Super fileIII(Engine) F4 | Withdrawn | |
| 31mm Roll Wave 20/7%Small 4pcs/pack | Withdrawn | |
| 25mm Super fileIII(Engine) F3 | Withdrawn | |
| 21mm Roll Wave Assorted | Withdrawn | |
| 21mm D-Shaper Assorted | Withdrawn | |
| 21mm D-Super file(Engine) SX-F3 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #35 | Withdrawn | |
| 25mm Super fileIII(Engine) S2 | Withdrawn | |
| 25mm Stainless Steel K-FILES (Hand Use) #10 | Withdrawn | |
| 25mm Stainless Steel K-FILES (Hand Use) #35 | Withdrawn | |
| 25mm Only One Files Blue R40 | Withdrawn | |
| 31mm Stainless Steel K-FILES (Hand Use) #30 | Withdrawn | |
| 25mm Roll Wave Assorted | Withdrawn | |
| 31mm Roll Wave 25/7%Primary 4pcs/pack | Withdrawn | |
| 19mm Super file III (Engine) SX | Withdrawn | |
| 31mm Only One Files Blue R25 | Withdrawn | |
| 21mm Super fileIII(Engine) SX-F3 | Withdrawn | |
| 31mm Super fileIII(Engine) F2 | Withdrawn | |
| 31mm Super fileIII(Engine) F5 | Withdrawn | |
| 25mm D-Shaper Assorted | Withdrawn | |
| 21mm Only One Files Blue R40 | 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.