Henry Schein
FILE - Channels PT Platinum 21MM Assortment - GX19, G1, G2, C1, C2, C3 21MM
53manufacturers in China registered for this device type
720catalogue 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 | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-06-16 |
| Record revised | 2018-12-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: FALSE |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1001109 | 6 | In distribution | |
| 5701846 | 6 | In distribution | |
| 2021141 | 3 | In distribution | |
| 1007002 | 6 | In distribution | |
| 1004453 | 6 | In distribution | |
| 1008718 | 6 | In distribution | |
| 5700548 | 6 | In distribution | |
| 1006688 | 6 | In distribution | |
| 1004210 | 6 | In distribution | |
| 5700547 | 6 | In distribution | |
| 2020136 | 6 | In distribution | |
| 1006180 | 6 | In distribution | |
| 2020393 | 6 | In distribution | |
| 1007248 | 6 | In distribution | |
| 1004642 | 6 | In distribution | |
| 1001256 | 6 | In distribution | |
| 5701778 | 6 | In distribution | |
| 1126029 | 6 | In distribution | |
| 5701820 | 6 | In distribution | |
| 5700556 | 6 | In distribution | |
| 2020190 | 6 | In distribution | |
| 1000379 | 4 | In distribution | |
| 5700815 | 6 | In distribution | |
| 5700563 | 6 | In distribution | |
| 1005429 | 6 | In distribution | |
| 1005741 | 6 | In distribution | |
| 5701845 | 6 | In distribution | |
| 1003023 | 6 | In distribution | |
| 1001437 | 6 | In distribution | |
| 5701804 | 6 | In distribution | |
| 1003533 | 6 | In distribution | |
| 9002942 | 6 | In distribution | |
| 1126027 | 6 | In distribution | |
| 1006646 | 4 | In distribution | |
| 5701251 | 6 | In distribution | |
| 5701280 | 6 | In distribution | |
| 5700567 | 6 | In distribution | |
| 5701818 | 6 | In distribution | |
| 1002022 | 4 | In distribution | |
| 1019949 | 6 | In distribution | |
| 1013706 | 6 | In distribution | |
| 1005776 | 6 | In distribution | |
| 1006688 | 6 | In distribution | |
| 5700551 | 6 | In distribution | |
| 1009024 | 6 | In distribution | |
| 1006268 | 6 | In distribution | |
| 2020215 | 6 | In distribution | |
| 5700570 | 6 | In distribution | |
| 2020139 | 6 | In distribution | |
| 2020085 | 6 | In distribution | |
| 5701051 | 6 | In distribution | |
| 1009072 | 6 | In distribution | |
| 1000591 | 6 | In distribution | |
| 1003484 | 6 | In distribution | |
| 5701780 | 6 | In distribution | |
| 5701277 | 6 | In distribution | |
| 1006268 | 6 | In distribution | |
| 2020386 | 6 | In distribution | |
| 1007248 | 6 | In distribution | |
| 1002674 | 6 | In distribution | |
| 5700556 | 6 | In distribution | |
| 5701747 | 6 | In distribution | |
| 5701770 | 6 | In distribution | |
| 1000069 | 6 | In distribution | |
| 5701773 | 6 | In distribution | |
| 1000767 | 6 | In distribution | |
| 5700807 | 6 | In distribution | |
| 2020400 | 6 | In distribution | |
| 5701249 | 6 | In distribution | |
| 1001010 | 6 | In distribution | |
| 5701752 | 6 | In distribution | |
| 5700544 | 6 | In distribution | |
| 5701861 | 6 | In distribution | |
| 1002032 | 6 | In distribution | |
| 1005081 | 6 | In distribution | |
| 1019576 | 6 | In distribution | |
| 1012891 | 6 | In distribution | |
| 1004137 | 6 | In distribution | |
| 2020072 | 6 | In distribution | |
| 1007002 | 6 | In distribution | |
| 2020096 | 6 | In distribution | |
| 5701805 | 6 | In distribution | |
| 1004873 | 6 | In distribution | |
| 5701234 | 6 | In distribution | |
| 1001251 | 6 | In distribution | |
| 5701264 | 6 | In distribution | |
| 2020388 | 6 | In distribution | |
| 1000767 | 6 | In distribution | |
| 2020385 | 6 | In distribution | |
| 5701287 | 6 | In distribution | |
| 1001671 | 6 | In distribution | |
| 1013475 | In distribution | ||
| 5701275 | 6 | In distribution | |
| 5701788 | 6 | In distribution | |
| 5701267 | 6 | In distribution | |
| 1007925 | 6 | In distribution | |
| 1000689 | 6 | In distribution | |
| 1006690 | 6 | In distribution | |
| 5700562 | 6 | In distribution | |
| 1000190 | 6 | In distribution | |
| 5700811 | 6 | In distribution | |
| 1006118 | 6 | In distribution | |
| 1002954 | 6 | In distribution | |
| 1007240 | 6 | In distribution | |
| 5701744 | 6 | In distribution | |
| 1004460 | 6 | In distribution | |
| 1007702 | 6 | In distribution | |
| 1002187 | 4 | In distribution | |
| 5701849 | 6 | In distribution | |
| 1000682 | 6 | In distribution | |
| 1008859 | 6 | In distribution | |
| 5701294 | 6 | In distribution | |
| 1009209 | 6 | In distribution | |
| 1001010 | 6 | In distribution | |
| 5701225 | 6 | In distribution | |
| 2020074 | 6 | In distribution | |
| 5700546 | 6 | In distribution | |
| 2020357 | 6 | In distribution | |
| 2020191 | 6 | In distribution | |
| 5701783 | 6 | In distribution | |
| 1007993 | 6 | In distribution | |
| 2020129 | 6 | In distribution | |
| 1000216 | 6 | In distribution | |
| 1013641 | 100 | In distribution | |
| 2020398 | 6 | In distribution | |
| 2020211 | 6 | In distribution | |
| 1005318 | 6 | In distribution | |
| 5700543 | 6 | In distribution | |
| 5701860 | 6 | In distribution | |
| 1000720 | 6 | In distribution | |
| 1001733 | 6 | In distribution | |
| 1007979 | 6 | In distribution | |
| 5700564 | 6 | In distribution | |
| 1009942 | 6 | In distribution | |
| 5701743 | 6 | In distribution | |
| 1004873 | 6 | In distribution | |
| 1007761 | 6 | In distribution | |
| 5701270 | 6 | In distribution | |
| 2021142 | 3 | In distribution | |
| 5701794 | 6 | In distribution | |
| 1017285 | 6 | In distribution | |
| 9000676 | 6 | In distribution | |
| 5701858 | 6 | In distribution | |
| 5701279 | 6 | In distribution | |
| 1000772 | 6 | In distribution | |
| 1001582 | 6 | In distribution | |
| 1001366 | 6 | In distribution | |
| 1126025 | 6 | In distribution | |
| 2020131 | 6 | In distribution | |
| 5700565 | 6 | In distribution | |
| 5700543 | 6 | In distribution | |
| 2020118 | 6 | In distribution | |
| 5701848 | 6 | In distribution | |
| 1012547 | 6 | In distribution | |
| 1004642 | In distribution | ||
| 2020189 | 6 | In distribution | |
| 5700809 | 6 | In distribution | |
| 2020394 | 6 | In distribution | |
| 2020122 | 6 | In distribution | |
| 5701233 | 6 | In distribution | |
| 5700554 | 6 | In distribution | |
| 5700810 | 6 | In distribution | |
| 5701855 | 6 | In distribution | |
| 1006678 | 6 | In distribution | |
| 5700554 | 6 | In distribution | |
| 5701839 | 6 | In distribution | |
| 5701232 | 6 | In distribution | |
| 5700557 | 6 | In distribution | |
| 2020141 | 6 | In distribution | |
| 1126024 | 6 | In distribution | |
| 1004240 | 6 | In distribution | |
| 5701291 | 6 | In distribution | |
| 2020389 | 6 | In distribution | |
| 5701246 | 6 | In distribution | |
| 2020075 | 6 | In distribution | |
| 5701286 | 6 | In distribution | |
| 1006892 | 6 | In distribution | |
| 1000227 | 6 | In distribution | |
| 1006678 | 6 | In distribution | |
| 2020387 | 6 | In distribution | |
| 5701790 | 6 | In distribution | |
| 1009439 | 6 | In distribution | |
| 5701851 | 6 | In distribution | |
| 5700560 | 6 | In distribution | |
| 1008766 | 4 | In distribution | |
| 2020098 | 6 | In distribution | |
| 1009921 | 6 | In distribution | |
| 1007259 | 6 | In distribution | |
| 1002443 | 6 | In distribution | |
| 5701052 | 6 | In distribution | |
| 2020397 | 6 | In distribution | |
| 1007993 | 6 | In distribution | |
| 1019542 | 250 | In distribution | |
| 1002085 | 4 | In distribution | |
| 2020093 | 6 | In distribution | |
| 2020099 | 6 | In distribution | |
| 1005280 | 6 | In distribution | |
| 1006617 | 6 | In distribution | |
| 5701227 | 6 | In distribution | |
| 2020355 | 6 | In distribution | |
| 1005377 | 6 | In distribution | |
| 1001295 | 6 | In distribution | |
| 5701259 | 6 | In distribution | |
| 5701281 | 6 | In distribution | |
| 5701829 | 6 | In distribution | |
| 1013450 | 6 | In distribution | |
| 2020080 | 6 | In distribution | |
| 5701806 | 6 | In distribution | |
| 5701801 | 6 | In distribution | |
| 1002758 | 6 | In distribution | |
| 5701757 | 6 | In distribution | |
| 5701224 | 6 | In distribution | |
| 1003484 | 6 | In distribution | |
| 2020358 | 6 | In distribution | |
| 1019418 | 6 | In distribution | |
| 5700569 | 6 | In distribution | |
| 2020137 | 6 | In distribution | |
| 9000678 | 6 | In distribution | |
| 1000498 | 6 | In distribution | |
| 5701812 | 6 | In distribution | |
| 2020111 | 6 | In distribution | |
| 2020391 | 6 | In distribution | |
| 5701228 | 6 | In distribution | |
| 1008457 | 6 | In distribution | |
| 1000867 | 6 | In distribution | |
| 5701230 | 6 | In distribution | |
| 1004237 | 6 | In distribution | |
| 5701265 | 6 | In distribution | |
| 1019949 | 6 | In distribution | |
| 5701797 | 6 | In distribution | |
| 5701755 | 6 | In distribution | |
| 1007014 | 6 | In distribution | |
| 1013109 | 6 | In distribution | |
| 5700559 | 6 | In distribution | |
| 5700555 | 6 | In distribution | |
| 5701817 | 6 | In distribution | |
| 5701835 | 6 | In distribution | |
| 2020401 | 6 | In distribution | |
| 1001671 | 6 | In distribution | |
| 5700566 | 6 | In distribution | |
| 5700808 | 6 | In distribution | |
| 2020102 | 6 | In distribution | |
| 2020084 | 6 | In distribution | |
| 2020384 | 6 | In distribution | |
| 1005776 | 6 | In distribution | |
| 1006972 | In distribution | ||
| 5701266 | 6 | In distribution | |
| 2020082 | 6 | In distribution | |
| 5701785 | 6 | In distribution | |
| 5701834 | 6 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.