EdgeSequel Sapphire
EdgeSequel Sapphire .04 Assortment – 015/020/025/030 – 21mm
53manufacturers in China registered for this device type
78catalogue 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 | FKG Dentaire Sàrl |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2025-11-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ES250625HTS | 4 | In distribution | |
| ES150625HTS | 4 | In distribution | |
| ES500421HTS | 4 | In distribution | |
| ES250631HTS | 4 | In distribution | |
| ES200421HTS | 4 | In distribution | |
| ES400625HTS | 4 | In distribution | |
| ES04153021ASST | 4 | In distribution | |
| ES500631HTS | 4 | In distribution | |
| ES800425HTS | 4 | In distribution | |
| ES250821HTS | 4 | In distribution | |
| ES300621HTS | 4 | In distribution | |
| ES04153025ASST | 4 | In distribution | |
| ES350425HTS | 4 | In distribution | |
| ES550431HTS | 4 | In distribution | |
| ES350625HTS | 4 | In distribution | |
| ES06153021ASST | 4 | In distribution | |
| ES250621HTS | 4 | In distribution | |
| ES400425HTS | 4 | In distribution | |
| ES04355031ASST | 4 | In distribution | |
| ES600425HTS | 4 | In distribution | |
| ES800421HTS | 4 | In distribution | |
| ES700431HTS | 4 | In distribution | |
| ES04355025ASST | 4 | In distribution | |
| ES450431HTS | 4 | In distribution | |
| ES900431HTS | 4 | In distribution | |
| ES300421HTS | 4 | In distribution | |
| ES900425HTS | 4 | In distribution | |
| ES700421HTS | 4 | In distribution | |
| ES150621HTS | 4 | In distribution | |
| ES300631HTS | 4 | In distribution | |
| ES450621HTS | 4 | In distribution | |
| ES250831HTS | 4 | In distribution | |
| ES350421HTS | 4 | In distribution | |
| ES300431HTS | 4 | In distribution | |
| ES550425HTS | 4 | In distribution | |
| ES450425HTS | 4 | In distribution | |
| ES200625HTS | 4 | In distribution | |
| ES800431HTS | 4 | In distribution | |
| ES550421HTS | 4 | In distribution | |
| ES500621HTS | 4 | In distribution | |
| ES700425HTS | 4 | In distribution | |
| ES500625HTS | 4 | In distribution | |
| ES250825HTS | 4 | In distribution | |
| ES400431HTS | 4 | In distribution | |
| ES900421HTS | 4 | In distribution | |
| ES500431HTS | 4 | In distribution | |
| ES350431HTS | 4 | In distribution | |
| ES450421HTS | 4 | In distribution | |
| ES400631HTS | 4 | In distribution | |
| ES600421HTS | 4 | In distribution | |
| ES04153031ASST | 4 | In distribution | |
| ES400621HTS | 4 | In distribution | |
| ES250425HTS | 4 | In distribution | |
| ES450631HTS | 4 | In distribution | |
| ES300425HTS | 4 | In distribution | |
| ES06153025ASST | 4 | In distribution | |
| ES06153031ASST | 4 | In distribution | |
| ES250431HTS | 4 | In distribution | |
| ES500425HTS | 4 | In distribution | |
| ES350621HTS | 4 | In distribution | |
| ES06355031ASST | 4 | In distribution | |
| ES150631HTS | 4 | In distribution | |
| ES200621HTS | 4 | In distribution | |
| ES600431HTS | 4 | In distribution | |
| ES06355021ASST | 4 | In distribution | |
| ES04355021ASST | 4 | In distribution | |
| ES150425HTS | 4 | In distribution | |
| ES450625HTS | 4 | In distribution | |
| ES150421HTS | 4 | In distribution | |
| ES200431HTS | 4 | In distribution | |
| ES400421HTS | 4 | In distribution | |
| ES300625HTS | 4 | In distribution | |
| ES200631HTS | 4 | In distribution | |
| ES150431HTS | 4 | In distribution | |
| ES06355025ASST | 4 | In distribution | |
| ES200425HTS | 4 | In distribution | |
| ES250421HTS | 4 | In distribution | |
| ES350631HTS | 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.