Endodontic Hand Instrument
Hedstrom: 90-140 25MM Lexicon
53manufacturers in China registered for this device type
50catalogue numbers in this listing
1510(k) clearance
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 | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-26 |
| Record revised | 2025-12-31 (version 3) |
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 |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HFS05525 | 6 | In distribution | |
| HFS154021 | 6 | In distribution | |
| HFS04025 | 6 | In distribution | |
| HFS03525 | 6 | In distribution | |
| HFS04031 | 6 | In distribution | |
| HFS08025 | 6 | In distribution | |
| HFS9014025 | 6 | In distribution | |
| HFS08021 | 6 | In distribution | |
| HFS01521 | 6 | In distribution | |
| HFS02525 | 6 | In distribution | |
| HFS05025 | 6 | In distribution | |
| HFS04525 | 6 | In distribution | |
| HFS05521 | 6 | In distribution | |
| HFS01525 | 6 | In distribution | |
| HFS04521 | 6 | In distribution | |
| HFS06025 | 6 | In distribution | |
| HFS01025 | 6 | In distribution | |
| HFS06021 | 6 | In distribution | |
| HFS9014021 | 6 | In distribution | |
| HFS458021 | 6 | In distribution | |
| HFS154025 | 6 | In distribution | |
| HFS03021 | 6 | In distribution | |
| HFS07021 | 6 | In distribution | |
| HFS03521 | 6 | In distribution | |
| HFS01021 | 6 | In distribution | |
| HFS02021 | 6 | In distribution | |
| HFS04021 | 6 | In distribution | |
| HFS07025 | 6 | In distribution | |
| HFS03025 | 6 | In distribution | |
| HFS02031 | 6 | In distribution | |
| HFS05021 | 6 | In distribution | |
| HFS03531 | 6 | In distribution | |
| HFS03031 | 6 | In distribution | |
| HFS02521 | 6 | In distribution | |
| HFS01531 | 6 | In distribution | |
| HFS02531 | 6 | In distribution | |
| HFS02025 | 6 | In distribution | |
| HFS458025 | 6 | In distribution | |
| SSK03231 | 6 | Withdrawn | |
| SSK02725 | 6 | Withdrawn | |
| SSK02231 | 6 | Withdrawn | |
| SSK02225 | 6 | Withdrawn | |
| SSK02221 | 6 | Withdrawn | |
| SSK02721 | 6 | Withdrawn | |
| SSK02731 | 6 | Withdrawn | |
| SSK03725 | 6 | Withdrawn | |
| SSK03721 | 6 | Withdrawn | |
| SSK03225 | 6 | Withdrawn | |
| SSK03221 | 6 | Withdrawn | |
| SSK03731 | 6 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933582 | 1993-10-20 |
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.