Zarc
109 catalogue numbers from SlimShaper PRO sterile files 25mm ZS1-ZS, listed by Shenzhen Denco Medical Co., Ltd., China, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
109catalogue 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 | 2025-07-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2030-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SlimShaper PRO sterile files 25mm ZS1-ZS3 (3 units) | In distribution | |
| Z Condensor Gold 25mm 030/06 (4 units) | In distribution | |
| NanoShaper 21 ZN2 (6 units) | In distribution | |
| Z-Micro Shaper de Zarc (Calibre 30.02) | In distribution | |
| NanoShaper Assorted 25 ZN1-ZN3 (3 units) | In distribution | |
| K File 21mm 08 Zarc (6 units) | In distribution | |
| Limas C+ 31 mm 15 (6 uds.) 31mm | In distribution | |
| BlueShaper PRO sterile files 31mm ZX-Z5 (6 units) | In distribution | |
| K File 25mm 08 Zarc (6 units) | In distribution | |
| Z-Gauge Ruler | In distribution | |
| Hedstrom sterile files 25mm 35 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z3 (6 units) | In distribution | |
| Limas C+ 31 mm 08 (6 uds.) 31mm | In distribution | |
| BlueShaper sterile files 31mm Z5 (6 units) | In distribution | |
| K File 31mm 08 Zarc (6 units) | In distribution | |
| Z-Micro Shaper de Zarc (Calibre 20.02) | In distribution | |
| BlueShaper PRO sterile files 31mm Z1-Z4 (4 units) | In distribution | |
| K File 25mm 30 Zarc (6 units) | In distribution | |
| Z-Micro Opener de Zarc (Calibre 10.04) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (50/100) | In distribution | |
| BlueShaper PRO sterile files 25mm Z1-Z4 (4 units) | In distribution | |
| Limas C+ 21 mm 08 (6 uds.) 21mm | In distribution | |
| BlueShaper PRO sterile files 25mm Z7 (6 units) | In distribution | |
| Z Condensor Gold 25mm 035/04 (4 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z3 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z3 (6 units) | In distribution | |
| Limas C+ 25 mm 08 (6 uds.) 25mm | In distribution | |
| BlueShaper sterile files 25mm Z4 (6 units) | In distribution | |
| NanoShaper Assorted 31 ZN1-ZN3 (3 units) | In distribution | |
| Hedstrom sterile files 25mm 20 (6 units) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (35/70) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS2 (6 units) | In distribution | |
| RetreatAll sterile retreatment files (4 units) | In distribution | |
| NanoShaper 21 ZN3 (6 units) | In distribution | |
| Hedstrom sterile files 31mm 08 (6 units) | In distribution | |
| K File 31mm 15 Zarc (6 units) | In distribution | |
| K File 25mm 20 Zarc (6 units) | In distribution | |
| NanoShaper 21 ZN1 (6 units) | In distribution | |
| NanoShaper 31 ZN3 (6 units) | In distribution | |
| K File 31mm 10 Zarc (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z2 (6 units) | In distribution | |
| K File 25mm 15 Zarc (6 units) | In distribution | |
| Hedstrom sterile files 31mm 15 (6 units) | In distribution | |
| Z-CLEAN | In distribution | |
| Hedstrom sterile Assorted 21mm 15-40 (6 units) | In distribution | |
| Hedstrom sterile files 21mm 08 (6 units) | In distribution | |
| Endo-Block Ruler | In distribution | |
| Hedstrom sterile Assorted 25mm 15-40 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z4 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z5 (6 units) | In distribution | |
| K File 21mm 10 Zarc (6 units) | In distribution | |
| Hedstrom sterile files 25mm 25 (6 units) | In distribution | |
| NanoShaper 25 ZN1 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z2 (6 units) | In distribution | |
| Hedstrom sterile files 25mm 30 (6 units) | In distribution | |
| Limas C+ 25 mm 15 (6 uds.) 25mm | In distribution | |
| Limas estériles Excalibur Glider 25mm (3 uds.) | In distribution | |
| K File 31mm 35 Zarc (6 units) | In distribution | |
| NanoShaper 31 ZN2 (6 units) | In distribution | |
| NanoShaper 25 ZN3 (6 units) | In distribution | |
| Limas C+ 21 mm 06 (6 uds.) 21mm | In distribution | |
| ApicalShaper sterile 25mm Z30-Z50 (4 units) | In distribution | |
| Limas C+ 25 mm 10 (6 uds.) 25mm | In distribution | |
| BlueShaper PRO sterile files 21mm Z2 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z40/03 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z4 (6 units) | In distribution | |
| Limas C+ 21 mm 10 (6 uds.) 21mm | In distribution | |
| Hedstrom sterile files 31mm 10 (6 units) | In distribution | |
| K File Flex 25mm 15 Zarc (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z1-Z4 (4 units) | In distribution | |
| Hedstrom sterile Assorted 25mm 45-80 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS1-ZS3 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z1 (6 units) | In distribution | |
| Excalibur sterile 25mm E20-E45 (4 units) | In distribution | |
| NanoShaper 25 ZN2 (6 units) | In distribution | |
| Hedstrom sterile files 31mm 20 (6 units) | In distribution | |
| K File 31mm 25 Zarc (6 units) | In distribution | |
| K File 25mm 25 Zarc (6 units) | In distribution | |
| K File 31mm 30 Zarc (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z1 (6 units) | In distribution | |
| Limas C+ 21 mm 15 (6 uds.) 21mm | In distribution | |
| K File 25mm 40 Zarc (6 units) | In distribution | |
| K File 25mm 35 Zarc (6 units) | In distribution | |
| Z-Micro Shaper de Zarc (Calibre 25.02) | In distribution | |
| Hedstrom sterile files 25mm 40 (6 units) | In distribution | |
| K File 31mm 20 Zarc (6 units) | In distribution | |
| Hedstrom sterile files 21mm 10 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z2 (6 units) | In distribution | |
| K File 31mm 06 Zarc (6 units) | In distribution | |
| Limas C+ 25 mm 06 (6 uds.) 25mm | In distribution | |
| BlueShaper PRO sterile files 31mm Z2 (6 units) | In distribution | |
| NanoShaper Assorted 21 ZN1-ZN3 (3 units) | In distribution | |
| Hedstrom sterile files 31mm 25 (6 units) | In distribution | |
| Hedstrom sterile files 25mm 08 (6 units) | In distribution | |
| K File 25mm 06 Zarc (6 units) | In distribution | |
| Limas C+ 31 mm 10 (6 uds.) 31mm | In distribution | |
| ApicalShaper sterile 21mm Z50/03 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z6 (6 units) | In distribution | |
| K File 31mm 40 Zarc (6 units) | In distribution | |
| NanoShaper 31 ZN1 (6 units) | In distribution | |
| Z-Micro Opener de Zarc (Calibre 15.04) | In distribution | |
| Z-Glider EVO sterile files 31mm | In distribution | |
| BlueShaper PRO sterile files 21mm Z4 (6 units) | In distribution | |
| Limas C+ 31 mm 06 (6 uds.) 31mm | In distribution | |
| BlueShaper PRO sterile files 31mm Z1 (6 units) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS2 (6 units) | In distribution | |
| Hedstrom sterile files 25mm 06 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS3 (6 units) | In distribution | |
| K File 25mm 10 Zarc (6 units) | 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.