Optimum
#15-40 Assorted Optimum™ Hedstroms File 25mm Pack of 6
53manufacturers in China registered for this device type
147catalogue 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 | Benco Dental Supply Co. |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2018-10-02 |
| Record revised | 2023-02-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4448-751 | In distribution | |
| 5906-138 | In distribution | |
| 4447-958 | In distribution | |
| 4447-887 | In distribution | |
| 4447-636 | In distribution | |
| 4448-966 | In distribution | |
| 5906-174 | In distribution | |
| 4448-466 | In distribution | |
| 5906-110 | In distribution | |
| 4448-331 | In distribution | |
| 4448-680 | In distribution | |
| 4448-859 | In distribution | |
| 4447-814 | In distribution | |
| 4448-993 | In distribution | |
| 4448-199 | In distribution | |
| 4448-984 | In distribution | |
| 4448-153 | In distribution | |
| 4447-850 | In distribution | |
| 5906-094 | In distribution | |
| 4448-171 | In distribution | |
| 4448-377 | In distribution | |
| 4448-699 | In distribution | |
| 4447-734 | In distribution | |
| 4448-368 | In distribution | |
| 4448-500 | In distribution | |
| 4448-386 | In distribution | |
| 4448-779 | In distribution | |
| 4448-000 | In distribution | |
| 4449-054 | In distribution | |
| 4448-117 | In distribution | |
| 4447-627 | In distribution | |
| 4448-644 | In distribution | |
| 4448-715 | In distribution | |
| 4448-877 | In distribution | |
| 4448-297 | In distribution | |
| 4448-215 | In distribution | |
| 4448-939 | In distribution | |
| 4448-493 | In distribution | |
| 4448-359 | In distribution | |
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| 4447-752 | In distribution | |
| 4448-519 | In distribution | |
| 5906-254 | In distribution | |
| 4447-967 | In distribution | |
| 4447-985 | In distribution | |
| 4448-242 | In distribution | |
| 5906-101 | In distribution | |
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| 4448-760 | In distribution | |
| 4448-537 | In distribution | |
| 4448-948 | In distribution | |
| 4448-091 | In distribution | |
| 4448-813 | In distribution | |
| 4448-662 | In distribution | |
| 4448-706 | In distribution | |
| 4448-457 | In distribution | |
| 4447-609 | In distribution | |
| 4447-789 | In distribution | |
| 4448-724 | In distribution | |
| 4448-224 | In distribution | |
| 5906-263 | In distribution | |
| 4448-395 | In distribution | |
| 4449-045 | In distribution | |
| 4447-618 | In distribution | |
| 4447-869 | In distribution | |
| 4448-279 | In distribution | |
| 4448-233 | In distribution | |
| 4447-743 | In distribution | |
| 4448-895 | In distribution | |
| 4448-028 | In distribution | |
| 4448-840 | In distribution | |
| 5906-325 | In distribution | |
| 4448-019 | In distribution | |
| 4447-994 | In distribution | |
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| 4448-180 | In distribution | |
| 4447-878 | In distribution | |
| 4448-260 | In distribution | |
| 4448-448 | In distribution | |
| 4447-912 | In distribution | |
| 5906-147 | In distribution | |
| 4447-805 | In distribution | |
| 4448-475 | In distribution | |
| 4448-402 | In distribution | |
| 5906-281 | In distribution | |
| 4448-162 | In distribution | |
| 4448-617 | In distribution | |
| 4448-313 | In distribution | |
| 4447-949 | In distribution | |
| 4448-733 | In distribution | |
| 4448-822 | In distribution | |
| 4448-582 | In distribution | |
| 4448-108 | In distribution | |
| 5906-085 | In distribution | |
| 4447-798 | In distribution | |
| 4449-063 | In distribution | |
| 4448-251 | In distribution | |
| 4448-868 | In distribution | |
| 4447-707 | In distribution | |
| 4448-484 | In distribution | |
| 4447-896 | In distribution | |
| 4447-841 | In distribution | |
| 4448-135 | In distribution | |
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| 5906-129 | In distribution | |
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| 4448-546 | In distribution | |
| 4448-073 | In distribution | |
| 4448-975 | In distribution | |
| 4448-064 | In distribution | |
| 4447-690 | In distribution | |
| 4448-957 | In distribution | |
| 4448-608 | In distribution | |
| 4447-645 | In distribution | |
| 4448-037 | 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.