Exactguide
Exactguide Rotary FILE.04 15-20-25-30 25MM Assorted - 4 Pack
53manufacturers in China registered for this device type
52catalogue 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 | SS White Burs LLC, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-02-17 |
| Record revised | 2025-05-09 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| UTGH062030 | 4 | In distribution | |
| UTGH062521 | 4 | In distribution | |
| NONE | 4 | In distribution | |
| UTGH045021 | 4 | In distribution | |
| UTGH064025 | 4 | In distribution | |
| UTGH064525 | 4 | In distribution | |
| UTGH062025 | 4 | In distribution | |
| UTGH063521 | 4 | In distribution | |
| UTGH063530 | 4 | In distribution | |
| UTGH042530 | 4 | In distribution | |
| UTGH042525 | 4 | In distribution | |
| UTGH064521 | 4 | In distribution | |
| NONE | 4 | In distribution | |
| UTGH062530 | 4 | In distribution | |
| UTGH064030 | 4 | In distribution | |
| UTGH042521 | 4 | In distribution | |
| UTGH063030 | 4 | In distribution | |
| UTGH042021 | 4 | In distribution | |
| UTGH062021 | 4 | In distribution | |
| UTGH064530 | 4 | In distribution | |
| UTGH042025 | 10 | In distribution | |
| UTGH061530 | 4 | In distribution | |
| UTGH044025 | 4 | In distribution | |
| UTGH043521 | 4 | In distribution | |
| UTGH044530 | 4 | In distribution | |
| UTGH063021 | 4 | In distribution | |
| UTGH061521 | 4 | In distribution | |
| UTGH042025 | 4 | In distribution | |
| UTGH043525 | 4 | In distribution | |
| UTGH043030 | 4 | In distribution | |
| UTGH041521 | 4 | In distribution | |
| UTGH063525 | 4 | In distribution | |
| UTGH042030 | 10 | In distribution | |
| UTGH044525 | 4 | In distribution | |
| UTGH043021 | 4 | In distribution | |
| UTGH041530 | 4 | In distribution | |
| UTGH044521 | 4 | In distribution | |
| UTGH044030 | 4 | In distribution | |
| UTGH065025 | 4 | In distribution | |
| UTGH065030 | 4 | In distribution | |
| UTGH043025 | 4 | In distribution | |
| UTGH041525 | 4 | In distribution | |
| UTGH042030 | 4 | In distribution | |
| UTGH045025 | 4 | In distribution | |
| UTGH063025 | 4 | In distribution | |
| UTGH043530 | 4 | In distribution | |
| UTGH045030 | 4 | In distribution | |
| UTGH064021 | 4 | In distribution | |
| UTGH062525 | 4 | In distribution | |
| UTGH044021 | 4 | In distribution | |
| UTGH061525 | 4 | In distribution | |
| UTGH065021 | 4 | 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.