Avalon Biomed
233 catalogue numbers from BlueShaper PRO sterile files 31mm Z7 (6 , 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
233catalogue 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 | 2025-07-21 |
| Record revised | 2025-06-23 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2030-11-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BlueShaper PRO sterile files 31mm Z7 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z3 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E20 (6 units) | In distribution | |
| Excalibur Glider PRO sterile 21mm (3 units) | In distribution | |
| Z-Glider EVO sterile files 25mm | In distribution | |
| Excalibur PRO sterile 25mm E20 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z6 (6 units) | In distribution | |
| Yellow File Organizer and autoclavable ruler Zarc | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (35/70) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS3 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E35 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z3 (6 units) | In distribution | |
| Excalibur PRO sterile 25mm E25 (6 units) | In distribution | |
| Excalibur sterile 25mm E35 (6 units) | In distribution | |
| Z-Micro Opener 15.04 (3 units) | In distribution | |
| Z-Micro Opener 10.04 (3 units) | In distribution | |
| SlimShaper sterile files 31mm ZS1 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS2 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z7 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z6 (6 units) | In distribution | |
| Z Condensor 21mm 035 (4 units) | In distribution | |
| Z Condensor 25mm 035 (4 units) | In distribution | |
| Excalibur sterile 31mm E20-E45 (4 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z3 (6 units) | In distribution | |
| Z-Micro Shaper 30.02 (3 units) | In distribution | |
| Endo-Block Ruler | In distribution | |
| ApicalShaper sterile 21mm Z30/03 (6 units) | In distribution | |
| SlimShaper sterile files 31mm ZS3 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z50/03 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E35 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z4 (6 units) | In distribution | |
| Excalibur PRO sterile 25mm E35 (6 units) | In distribution | |
| Z Condensor 25mm 025 (4 units) | In distribution | |
| SlimShaper sterile files 21mm ZS1 (6 units) | In distribution | |
| Excalibur PRO sterile 25mm E20 (6 units) | In distribution | |
| Excalibur sterile 31mm E35 (6 units) | In distribution | |
| SlimShaper sterile files 25mm ZS1 (6 units) | In distribution | |
| Z-Micro Shaper 25.02 (3 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS2 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E25 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS3 (6 units) | In distribution | |
| SlimShaper sterile files 31mm ZS2 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS1 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z4 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS1-ZS3 (6 units) | In distribution | |
| BlueShaper sterile files 25mm ZX-Z5 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z1 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z40/03 (6 units) | In distribution | |
| Excalibur sterile 21mm E20-E45 (4 units) | In distribution | |
| Z-Glider sterile files 25mm (3 units) | In distribution | |
| BlueShaper sterile files 25mm Z6 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E45 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z3 (6 units) | In distribution | |
| BlueShaper PRO sterile 21mm ZXS-Z5 | In distribution | |
| Excalibur sterile 21mm E25 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm ZX-Z5 (6 units) | In distribution | |
| BlueShaper sterile files 19mm ZX (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z2 (6 units) | In distribution | |
| BlueShaper PRO sterile files 19mm ZX (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z7 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z1-Z4 (4 units) | In distribution | |
| Excalibur sterile 25mm E25 (6 units) | In distribution | |
| BlueShaper sterile files 21mm ZX-Z5 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z30/03 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E20-E45 (4 units) | In distribution | |
| SlimShaper sterile files 25mm ZS3 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z4 (6 units) | In distribution | |
| Z Condensor 21mm 040 (4 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z2 (6 units) | In distribution | |
| Z-Glider sterile files 21mm (3 units) | In distribution | |
| Excalibur PROsterile 25mm E45 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z7 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z2 (6 units) | In distribution | |
| BlueShaper PRO sterile files 16mm ZXS (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z1 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z1-Z4 (4 units) | In distribution | |
| BlueShaper PRO sterile files 25mm ZX-Z5 (6 units) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (60/120) | In distribution | |
| BlueShaper sterile files 21mm Z2 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z5 (6 units) | In distribution | |
| Excalibur sterile 31mm E25 (6 units) | In distribution | |
| Excalibur PROsterile 25mm E45 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z3 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z3 (6 units) | In distribution | |
| Excalibur sterile 25mm E25 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS3 (6 units) | In distribution | |
| ApicalShaper sterile 31mm Z50/03 (6 units) | In distribution | |
| NanoShaper 31 ZN3 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS1 (6 units) | In distribution | |
| Z-Glider EVO sterile files 21mm | In distribution | |
| Excalibur Glider PRO sterile 21mm (3 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS2 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E20-E45 (4 units) | In distribution | |
| Excalibur PRO sterile 21mm E45 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E20-E45 (4 units) | In distribution | |
| ApicalShaper sterile 31mm Z30/03 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z1 (6 units) | In distribution | |
| Excalibur sterile 21mm E35 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E20-E45 (4 units) | In distribution | |
| Excalibur PRO sterile 21mm E35 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z1-Z4 (4 units) | In distribution | |
| Z Condensor 21mm 030 (4 units) | In distribution | |
| Excalibur PRO sterile 25mm E25 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z5 (6 units) | In distribution | |
| ApicalShaper sterile 21mm Z40/03 (6 units) | In distribution | |
| Z Condensor 25mm 040 (4 units) | In distribution | |
| Pink File Organizer and autoclavable ruler Zarc | In distribution | |
| SlimShaper sterile files 31mm ZS1-ZS3 (6 units) | In distribution | |
| NanoShaper 21 ZN3 (6 units) | In distribution | |
| NanoShaper 25 ZN3 (6 units) | In distribution | |
| Z Condensor 25mm 045 (4 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z3 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z5 (6 units) | In distribution | |
| ApicalShaper sterile 31mm Z40/03 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z50/03 (6 units) | In distribution | |
| SlimShaper sterile files 31mm ZS1-ZS3 (6 units) | In distribution | |
| Z-Glider EVO sterile files 25mm | In distribution | |
| Excalibur sterile 25mm E20 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z5 (6 units) | In distribution | |
| Excalibur sterile 31mm E45 (6 units) | In distribution | |
| NanoShaper 31 ZN2 (6 units) | In distribution | |
| NanoShaper 31 ZN1 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z7 (6 units) | In distribution | |
| NanoShaper 21 ZN2 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E45 (6 units) | In distribution | |
| ApicalShaper sterile 31mm Z35/03 (6 units) | In distribution | |
| Z Condensor 21mm 025 (4 units) | In distribution | |
| Z Condensor 25mm 030 (4 units) | In distribution | |
| BlueShaper sterile files 25mm Z3 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS1-ZS3 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E20 (6 units) | In distribution | |
| Excalibur PRO sterile 25mm E20-E45 (4 units) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS1-ZS3 (6 units) | In distribution | |
| SlimShaper sterile files 25mm ZS1-ZS3 (6 units) | In distribution | |
| Excalibur Glider PRO sterile 25mm (3 units) | In distribution | |
| ApicalShaper sterile 31mm Z30-Z50 (4 units) | In distribution | |
| BlueShaper sterile files 31mm Z1-Z4 (4 units) | In distribution | |
| SlimShaper sterile files 21mm ZS2 (6 units) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (Surtido) | In distribution | |
| Excalibur sterile 25mm E20-E45 (4 units) | In distribution | |
| NanoShaper 25 ZN1 (6 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z5 (6 units) | In distribution | |
| Excalibur Glider PRO sterile 31mm (3 units) | In distribution | |
| ApicalShaper sterile 21mm Z50/03 (6 units) | In distribution | |
| Excalibur PRO sterile 25mm E35 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z4 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z1 (6 units) | In distribution | |
| BlueShaper sterile files 31mm ZX-Z5 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E25 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z1-Z4 (4 units) | In distribution | |
| NanoShaper Assorted 21 ZN1-ZN3 (3 units) | In distribution | |
| ApicalShaper sterile 21mm Z35/03 (6 units) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS1-ZS3 (3 units) | In distribution | |
| RetreatAll sterile retreatment files (4 units) | In distribution | |
| BlueShaper sterile files 21mm Z6 (6 units) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS1 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E25 (6 units) | In distribution | |
| SlimShaper sterile files 25mm ZS2 (6 units) | In distribution | |
| Z-Glider EVO sterile files 31mm | In distribution | |
| NanoShaper Assorted 25 ZN1-ZN3 (3 units) | In distribution | |
| NanoShaper Assorted 31 ZN1-ZN3 (3 units) | In distribution | |
| Z Condensor 21mm 045 (4 units) | In distribution | |
| Blue File Organizer and autoclavable ruler Zarc | In distribution | |
| Z-Gauge Ruler | In distribution | |
| Z-Micro Opener 20.04 (3 units) | In distribution | |
| Excalibur PRO sterile 25mm E20-E45 (4 units) | In distribution | |
| Excalibur sterile 31mm E20 (6 units) | In distribution | |
| SlimShaper sterile files 21mm ZS3 (6 units) | In distribution | |
| Excalibur Glider PRO sterile 25mm (3 units) | In distribution | |
| ApicalShaper sterile 25mm Z30-Z50 (4 units) | In distribution | |
| Excalibur sterile 21mm E20 (6 units) | In distribution | |
| ApicalShaper sterile 25mm Z35/03 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z5 (6 units) | In distribution | |
| BlueShaper PRO sterile 31mm ZXS-Z5 | In distribution | |
| BlueShaper PRO sterile files 25mm Z6 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z5 (6 units) | In distribution | |
| Z-Micro Opener ASSORTED (3 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z1-Z4 (4 units) | In distribution | |
| BlueShaper PRO sterile files 31mm Z4 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS1-ZS3 (3 units) | In distribution | |
| BlueShaper PRO sterile files 31mm ZX-Z5 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z2 (6 units) | In distribution | |
| NanoShaper 21 ZN1 (6 units) | In distribution | |
| BlueShaper PRO sterile files 21mm Z1 (6 units) | In distribution | |
| BlueShaper sterile files 21mm Z1 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E20 (6 units) | In distribution | |
| Excalibur PRO sterile 31mm E45 (6 units) | In distribution | |
| Excalibur sterile 25mm E45 (6 units) | In distribution | |
| Excalibur sterile 21mm E45 (6 units) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (40/80) | In distribution | |
| BlueShaper sterile files 31mm Z1 (6 units) | In distribution | |
| SlimShaper PRO sterile files 31mm ZS1-ZS3 (3 units) | In distribution | |
| Z-Glider sterile files 31mm (3units) | In distribution | |
| BlueShaper sterile files 31mm Z7 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E20 (6 units) | In distribution | |
| Z-Micro Shaper ASSORTED (3 units) | In distribution | |
| NanoShaper 25 ZN2 (6 units) | In distribution | |
| BlueShaper sterile files 31mm Z6 (6 units) | In distribution | |
| Excalibur sterile 31mm E25 (6 units) | In distribution | |
| Atacadores manuales Z-Plugger de Zarc (50/100) | In distribution | |
| Z-Micro Shaper 20.02 (3 units) | In distribution | |
| Excalibur PRO sterile 21mm E35 (6 units) | In distribution | |
| Excalibur PRO sterile 21mm E25 (6 units) | In distribution | |
| BlueShaper PRO sterile files 25mm Z1-Z4 (4 units) | In distribution | |
| ApicalShaper sterile 21mm Z30-Z50 (4 units) | In distribution | |
| SlimShaper sterile files 21mm ZS1-ZS3 (6 units) | In distribution | |
| SlimShaper PRO sterile files 25mm ZS3 (6 units) | In distribution | |
| Excalibur sterile 25mm E20 (6 units) | In distribution | |
| Excalibur Glider PRO sterile 31mm (3 units) | In distribution | |
| ApicalShaper sterile 21mm Z30-Z50 (4 units) | In distribution | |
| SlimShaper PRO sterile files 21mm ZS2 (6 units) | In distribution | |
| BlueShaper sterile files 25mm Z2 (6 units) | In distribution | |
| BlueShaper PRO sterile 25mm ZXS-Z5 | In distribution | |
| BlueShaper PRO sterile files 25mm Z4 (6 units) | In distribution | |
| SlimShaper sterile 21mm ZS1-ZS3 | Withdrawn | |
| Excalibur sterile 21mm E35 | Withdrawn | |
| BlueShaper sterile 25mm Z1 | Withdrawn | |
| SlimShaper sterile 21mm ZS2 | Withdrawn | |
| Excalibur sterile 25mm E45 | Withdrawn | |
| SlimShaper sterie 25mm ZS2 | Withdrawn | |
| ApicalShaper sterile 25mm Z35/03 | Withdrawn | |
| BlueShaper sterile 19mm ZX | Withdrawn | |
| SlimShaper sterile 21mm ZS1 | Withdrawn | |
| Excalibur sterile 25mm E35 | Withdrawn | |
| ApicalShaper sterile 21mm Z30/03 | Withdrawn | |
| Excalibur sterile 21mm E45 | Withdrawn | |
| SlimShaper sterie 25mm ZS1 | Withdrawn | |
| SlimShaper sterie 25mm ZS3 | Withdrawn | |
| SlimShaper sterile 21mm ZS3 | Withdrawn | |
| ApicalShaper sterile 25mm Z30/03 | Withdrawn | |
| Excalibur sterile 21mm E25 | Withdrawn | |
| ApicalShaper sterile 31mm Z30/03 | Withdrawn | |
| BlueShaper sterile 21mm ZX-Z5 | 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 |
| 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 |
| K-Files | Diadent Group Intl., Inc. | 188 |
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.