EdgeEndo
EdgeOnyx, x-Find: Size 09.09 -15mm, x-Follow: Size 15.04 - 21mm, x-Finish: Size 20.04, 25.04, 30.04, 35.04 - 21mm
53manufacturers in China registered for this device type
96catalogue 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 | HSG-S Corp, 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 | 2026-03-23 |
| Record revised | 2026-07-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EUKF621 | 6 | In distribution | |
| ETBUA25SU | In distribution | ||
| EUCF625 | 6 | In distribution | |
| EOBU4521SU | 3 | In distribution | |
| EUKF103521 | 6 | In distribution | |
| EUKF8025 | 6 | In distribution | |
| EO300425HTX | 6 | In distribution | |
| EOBUA21SU | In distribution | ||
| EO200425HTX | 6 | In distribution | |
| EUKF3025 | 6 | In distribution | |
| EUKF4025 | 6 | In distribution | |
| EUCF821 | 6 | In distribution | |
| EO350421HTX | 6 | In distribution | |
| EOBU2025SU | 3 | In distribution | |
| EUKF3525 | 6 | In distribution | |
| EOBURG1431SU | 3 | In distribution | |
| EUKF5521 | 6 | In distribution | |
| EUKF1021 | 6 | In distribution | |
| EO150421HTX | 6 | In distribution | |
| EO170425HTX | 6 | In distribution | |
| EUCF1521 | 6 | In distribution | |
| EOASST21HTX | 6 | In distribution | |
| EUKF1521 | 6 | In distribution | |
| EUKF1025 | 6 | In distribution | |
| EUKF8021 | 6 | In distribution | |
| ETBUF225SU | 6 | In distribution | |
| EO450421HTX | 6 | In distribution | |
| EO350425HTX | 6 | In distribution | |
| ETBUA31SU | In distribution | ||
| EUCF1021 | 6 | In distribution | |
| EUKF3521 | 6 | In distribution | |
| ETBUF331SU | 6 | In distribution | |
| EOBU2525SU | 3 | In distribution | |
| EUKF821 | 6 | In distribution | |
| EO170421HTX | 6 | In distribution | |
| ETBUA21SU | In distribution | ||
| ETBUS221SU | 6 | In distribution | |
| EO250425HTX | 6 | In distribution | |
| ETBUF231SU | 6 | In distribution | |
| EOBU2521SU | 3 | In distribution | |
| ETBUS131SU | 6 | In distribution | |
| ETBUS125SU | 6 | In distribution | |
| EUKF2521 | 6 | In distribution | |
| EUKF3021 | 6 | In distribution | |
| EUCF1025 | 6 | In distribution | |
| EOBURG1425SU | 3 | In distribution | |
| ETBUF125SU | 6 | In distribution | |
| EOBU3521SU | 3 | In distribution | |
| EUCF825 | 6 | In distribution | |
| EUKF2525 | 6 | In distribution | |
| EUKF4525 | 6 | In distribution | |
| ETBUF221SU | 6 | In distribution | |
| ETBUF131SU | 6 | In distribution | |
| EUKF1525 | 6 | In distribution | |
| EO300421HTX | 6 | In distribution | |
| EO200421HTX | 6 | In distribution | |
| EUKF5025 | 6 | In distribution | |
| EUKF625 | 6 | In distribution | |
| EO090915HTX | 6 | In distribution | |
| ETBUS225SU | 6 | In distribution | |
| ETBUF321SU | 6 | In distribution | |
| EUKF4521 | 6 | In distribution | |
| EUKF5021 | 6 | In distribution | |
| EO400421HTX | 6 | In distribution | |
| EOBU2531SU | 3 | In distribution | |
| EUKF6021 | 6 | In distribution | |
| EOBU3531SU | 3 | In distribution | |
| EOBUA31SU | In distribution | ||
| EUCF621 | 6 | In distribution | |
| ETBUS121SU | 6 | In distribution | |
| EOBU2021SU | 3 | In distribution | |
| EUKF7021 | 6 | In distribution | |
| EO400425HTX | 6 | In distribution | |
| EUKF4021 | 6 | In distribution | |
| EOBUA25SU | In distribution | ||
| EOBU4531SU | 3 | In distribution | |
| EUKF2021 | 6 | In distribution | |
| EUKF5525 | 6 | In distribution | |
| EOBU4525SU | 3 | In distribution | |
| EOBU3525SU | 3 | In distribution | |
| EOBU2031SU | 3 | In distribution | |
| EO150425HTX | 6 | In distribution | |
| ETBUF325SU | 6 | In distribution | |
| EO250421HTX | 6 | In distribution | |
| EUKF825 | 6 | In distribution | |
| EUKF103525 | 6 | In distribution | |
| EOBURG1421SU | 3 | In distribution | |
| ETBUSX19SU | 6 | In distribution | |
| EUKF2025 | 6 | In distribution | |
| EUCF1525 | 6 | In distribution | |
| ETBUF121SU | 6 | In distribution | |
| EOASST25HTX | 6 | In distribution | |
| EUKF7025 | 6 | In distribution | |
| ETBUS231SU | 6 | In distribution | |
| EO450425HTX | 6 | In distribution | |
| EUKF6025 | 6 | 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.