Hedstrom-Files
Hedstrom Files 31MM 90-110
53manufacturers in China registered for this device type
82catalogue 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 | 2022-10-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 07331045R | 6 | In distribution | |
| 07321060R | 6 | In distribution | |
| 07321035R | 6 | In distribution | |
| 07321008R | 6 | In distribution | |
| 07321090R | 6 | In distribution | |
| 07331030R | 6 | In distribution | |
| 07321160R | 6 | In distribution | |
| 07321008R | 6 | In distribution | |
| 07331155R | 6 | In distribution | |
| 07331050R | 6 | In distribution | |
| 07325055R | 6 | In distribution | |
| 07325080R | 6 | In distribution | |
| 07328020R | 6 | In distribution | |
| 07331050R | 6 | In distribution | |
| 07331040R | 6 | In distribution | |
| 07331055R | 6 | In distribution | |
| 07328030R | 6 | In distribution | |
| 07321045R | 6 | In distribution | |
| 07325030R | 6 | In distribution | |
| 07325060R | 6 | In distribution | |
| 07321080R | 6 | In distribution | |
| 07328025R | 6 | In distribution | |
| 07331015R | 6 | In distribution | |
| 07325025R | 6 | In distribution | |
| 07331008R | 6 | In distribution | |
| 07325040R | 6 | In distribution | |
| 07328020R | 6 | In distribution | |
| 07331035R | 6 | In distribution | |
| 07331055R | 6 | In distribution | |
| 07321020R | 6 | In distribution | |
| 07328160R | 6 | In distribution | |
| 07321040R | 6 | In distribution | |
| 07331030R | 6 | In distribution | |
| 07325160R | 6 | In distribution | |
| 07331170R | 6 | In distribution | |
| 07328015R | 6 | In distribution | |
| 07331035R | 6 | In distribution | |
| 07331015R | 6 | In distribution | |
| 07325015R | 6 | In distribution | |
| 07325165R | 6 | In distribution | |
| 07321025R | 6 | In distribution | |
| 07325050R | 6 | In distribution | |
| 07331010R | 6 | In distribution | |
| 07331155R | 6 | In distribution | |
| 07331025R | 6 | In distribution | |
| 07325008R | 6 | In distribution | |
| 07325070R | 6 | In distribution | |
| 07325035R | 6 | In distribution | |
| 07321030R | 6 | In distribution | |
| 07321160R | 6 | In distribution | |
| 07328015R | 6 | In distribution | |
| 07321165R | 6 | In distribution | |
| 07321010R | 6 | In distribution | |
| 07328030R | 6 | In distribution | |
| 07331165R | 6 | In distribution | |
| 07321015R | 6 | In distribution | |
| 07325010R | 6 | In distribution | |
| 07328035R | 6 | In distribution | |
| 07321070R | 6 | In distribution | |
| 07321165R | 6 | In distribution | |
| 07331020R | 6 | In distribution | |
| 07325010R | 6 | In distribution | |
| 07325160R | 6 | In distribution | |
| 07321055R | 6 | In distribution | |
| 07325060R | 6 | In distribution | |
| 07325015R | 6 | In distribution | |
| 07331008R | 6 | In distribution | |
| 07321050R | 6 | In distribution | |
| 07331040R | 6 | In distribution | |
| 07321050R | 6 | In distribution | |
| 07325080R | 6 | In distribution | |
| 07325055R | 6 | In distribution | |
| 07321045R | 6 | In distribution | |
| 07328040R | 6 | In distribution | |
| 07325045R | 6 | In distribution | |
| 07325165R | 6 | In distribution | |
| 07325070R | 6 | In distribution | |
| 07325020R | 6 | In distribution | |
| 07325025R | 6 | In distribution | |
| 07321055R | 6 | In distribution | |
| 07331160R | 6 | In distribution | |
| 07321070R | 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
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.