Darby Dental Supply, LLC
Hedstrom Files with Silicone Stops 25mm 90-110
53manufacturers in China registered for this device type
456catalogue 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 | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2019-06-04 |
| Record revised | 2018-12-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 300038 | 6 | In distribution | |
| 5250848 | 6 | In distribution | |
| 5254503 | 6 | In distribution | |
| 5250837 | 6 | In distribution | |
| 300026 | 6 | In distribution | |
| 5252510 | 6 | In distribution | |
| 9512645 | 6 | In distribution | |
| 5252501 | 6 | In distribution | |
| 5250801 | 6 | In distribution | |
| 5252505 | 6 | In distribution | |
| 5250851 | 6 | In distribution | |
| 9519872 | 250 | In distribution | |
| 250037 | 6 | In distribution | |
| 9544138 | 6 | In distribution | |
| 5252540 | 6 | In distribution | |
| 5250821 | 6 | In distribution | |
| 9512445 | 6 | In distribution | |
| 5252519 | 6 | In distribution | |
| 250053 | 6 | In distribution | |
| 300012 | 6 | In distribution | |
| 5250778 | 6 | In distribution | |
| 5250747 | 6 | In distribution | |
| 300000 | 6 | In distribution | |
| 5252517 | 6 | In distribution | |
| 9512553 | 6 | In distribution | |
| 5252492 | 6 | In distribution | |
| 5250795 | 6 | In distribution | |
| 5255574 | 6 | In distribution | |
| 250051 | 6 | In distribution | |
| 5252541 | 6 | In distribution | |
| 5250792 | 6 | In distribution | |
| 9512599 | 6 | In distribution | |
| 5250819 | 6 | In distribution | |
| 5252484 | 6 | In distribution | |
| 5250791 | 6 | In distribution | |
| 5252543 | 6 | In distribution | |
| 250041 | 6 | In distribution | |
| 5252511 | 6 | In distribution | |
| 5250822 | 6 | In distribution | |
| 9528077 | 6 | In distribution | |
| 5252477 | 6 | In distribution | |
| 5252521 | 6 | In distribution | |
| 5250836 | 6 | In distribution | |
| 5250787 | 6 | In distribution | |
| 250028 | 6 | In distribution | |
| 5252476 | 6 | In distribution | |
| 9512731 | 6 | In distribution | |
| 250046 | 6 | In distribution | |
| 5255587 | 6 | In distribution | |
| 9512437 | 6 | In distribution | |
| 5250853 | 6 | In distribution | |
| 9512615 | 6 | In distribution | |
| 9512417 | 6 | In distribution | |
| 9512593 | 6 | In distribution | |
| 9512729 | 6 | In distribution | |
| 5252525 | 6 | In distribution | |
| 5250814 | 6 | In distribution | |
| 9512440 | 6 | In distribution | |
| 9512551 | 6 | In distribution | |
| 5250768 | 6 | In distribution | |
| 5250852 | 6 | In distribution | |
| 5252506 | 6 | In distribution | |
| 300006 | 6 | In distribution | |
| 9528087 | 6 | In distribution | |
| 9512613 | 6 | In distribution | |
| 9512473 | 6 | In distribution | |
| 9519772 | 100 | In distribution | |
| 300023 | 6 | In distribution | |
| 5250774 | 6 | In distribution | |
| 5254504 | 6 | In distribution | |
| 9512633 | 6 | In distribution | |
| 5250789 | 6 | In distribution | |
| 5250760 | 6 | In distribution | |
| 5250809 | 6 | In distribution | |
| 5250771 | 6 | In distribution | |
| 9519862 | 250 | In distribution | |
| 9544144 | 6 | In distribution | |
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| 5250741 | 6 | In distribution | |
| 5255579 | 6 | In distribution | |
| 5250845 | 6 | In distribution | |
| 9544170 | 6 | In distribution | |
| 5254499 | 6 | In distribution | |
| 300005 | 6 | In distribution | |
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| 5250844 | 6 | In distribution | |
| 9512421 | 6 | In distribution | |
| 300009 | 6 | In distribution | |
| 250036 | 6 | In distribution | |
| 9528089 | 6 | In distribution | |
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| 5255585 | 6 | In distribution | |
| 300017 | 6 | In distribution | |
| 5250808 | 6 | In distribution | |
| 5250797 | 6 | In distribution | |
| 5250847 | 6 | In distribution | |
| 300047 | 6 | In distribution | |
| 5250817 | 6 | In distribution | |
| 9512767 | 6 | In distribution | |
| 5252533 | 6 | In distribution | |
| 5252487 | 6 | In distribution | |
| 9519776 | 100 | In distribution | |
| 5254505 | 6 | In distribution | |
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| 9512653 | 6 | In distribution | |
| 5250869 | 6 | In distribution | |
| 300033 | 6 | In distribution | |
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| 300024 | 6 | In distribution | |
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| 5252472 | 6 | In distribution | |
| 300035 | 6 | In distribution | |
| 300008 | 6 | In distribution | |
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| 300028 | 6 | In distribution | |
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| 9510151 | 6 | In distribution | |
| 9519864 | 250 | In distribution | |
| 5250755 | 6 | In distribution | |
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| 300043 | 6 | In distribution | |
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| 300022 | 6 | In distribution | |
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| 300021 | 6 | In distribution | |
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| 9544172 | 6 | In distribution | |
| 250024 | 6 | In distribution | |
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| 5250776 | 6 | In distribution | |
| 5250748 | 6 | In distribution | |
| 9544134 | 6 | In distribution | |
| 300025 | 6 | In distribution | |
| 5250855 | 6 | In distribution | |
| 5250754 | 6 | In distribution | |
| 250039 | 6 | In distribution | |
| 5252512 | 6 | In distribution | |
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| 5250843 | 6 | In distribution | |
| 250043 | 6 | In distribution | |
| 9544150 | 6 | In distribution | |
| 9512611 | 6 | In distribution | |
| 5250865 | 6 | In distribution | |
| 9519774 | 100 | In distribution | |
| 5250781 | 6 | In distribution | |
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| 250052 | 6 | In distribution | |
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| 5252539 | 6 | In distribution | |
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| 300027 | 6 | In distribution | |
| 9512639 | 6 | In distribution | |
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| 300013 | 6 | In distribution | |
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| 5252499 | 6 | In distribution | |
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| 250038 | 6 | In distribution | |
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| 5250744 | 6 | In distribution | |
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| 250031 | 6 | In distribution | |
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| 5250779 | 6 | In distribution | |
| 300031 | 6 | In distribution | |
| 9512453 | 6 | In distribution | |
| 250025 | 6 | In distribution | |
| 5254494 | 6 | In distribution | |
| 300045 | 6 | In distribution | |
| 9512743 | 6 | In distribution | |
| 5255586 | 6 | In distribution | |
| 5250753 | 6 | In distribution | |
| 9512423 | 6 | In distribution | |
| 5250866 | 6 | In distribution | |
| 5250810 | 6 | In distribution | |
| 5252475 | 6 | In distribution | |
| 9544186 | 6 | In distribution | |
| 5250766 | 6 | In distribution | |
| 300014 | 6 | In distribution | |
| 9519792 | 100 | In distribution | |
| 9512555 | 6 | In distribution | |
| 300036 | 6 | In distribution | |
| 300011 | 6 | In distribution | |
| 9519870 | 250 | In distribution | |
| 5252527 | 6 | In distribution | |
| 5250829 | 6 | In distribution | |
| 5250758 | 6 | In distribution | |
| 9528090 | 6 | In distribution | |
| 9512641 | 6 | In distribution | |
| 5250849 | 6 | In distribution | |
| 5250840 | 6 | In distribution | |
| 5252522 | 6 | In distribution | |
| 5255576 | 6 | In distribution | |
| 9512751 | 6 | In distribution | |
| 5255584 | 6 | In distribution | |
| 9512547 | 6 | In distribution | |
| 5250763 | 6 | In distribution | |
| 9544190 | 6 | In distribution | |
| 5252489 | 6 | In distribution | |
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| 5250864 | 6 | In distribution | |
| 300029 | 6 | In distribution | |
| 5250762 | 6 | In distribution | |
| 9512471 | 6 | In distribution | |
| 9512603 | 6 | In distribution | |
| 9512669 | 6 | In distribution | |
| 9512429 | 6 | In distribution | |
| 300019 | 6 | In distribution | |
| 5252481 | 6 | In distribution | |
| 9512451 | 6 | In distribution | |
| 5252504 | 6 | In distribution | |
| 9512629 | 6 | In distribution | |
| 5250811 | 6 | In distribution | |
| 5252485 | 6 | In distribution | |
| 5252529 | 6 | In distribution | |
| 5250761 | 6 | In distribution | |
| 9512601 | 6 | In distribution | |
| 300039 | 6 | In distribution | |
| 300015 | 6 | In distribution | |
| 5250835 | 6 | In distribution | |
| 9512737 | 6 | In distribution | |
| 5250780 | 6 | In distribution | |
| 9512749 | 6 | In distribution | |
| 5252509 | 6 | In distribution | |
| 9512745 | 6 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| K-Files | Diadent Group Intl., Inc. | 188 |
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.