Integra® Miltex®
Flex-R® Files - Flexible Roane Tip w/Stop, Assortment #15-40 31mm
53manufacturers in China registered for this device type
658catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-03 |
| Record revised | 2022-07-14 (version 6) |
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 |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 012-15072 | 6 | Withdrawn | |
| 012-28109 | 6 | Withdrawn | |
| 700502-4000-001 | 100 | Withdrawn | |
| EM815-3008 | 5 | Withdrawn | |
| 012-28450 | Withdrawn | ||
| 012-28017 | 6 | Withdrawn | |
| 012-11076 | 6 | Withdrawn | |
| 012-28003 | 6 | Withdrawn | |
| DKF21/20 | 6 | Withdrawn | |
| 012-11001 | 6 | Withdrawn | |
| 012-14076 | Withdrawn | ||
| 012-14187 | 6 | Withdrawn | |
| EMH212 | 5 | Withdrawn | |
| 012-15062 | 6 | Withdrawn | |
| 012-S4002 | 6 | Withdrawn | |
| 012-15003 | 6 | Withdrawn | |
| 012-S1006 | 6 | Withdrawn | |
| 012-14009 | 6 | Withdrawn | |
| 012-11189 | 6 | Withdrawn | |
| 012-S1186 | 6 | Withdrawn | |
| 012-15004 | 6 | Withdrawn | |
| 012-S1008 | 6 | Withdrawn | |
| 012-S0005 | 6 | Withdrawn | |
| 012-S4068 | 6 | Withdrawn | |
| 012-S1061 | 6 | Withdrawn | |
| 012-10065 | 6 | Withdrawn | |
| 012-15101 | 6 | Withdrawn | |
| 012-14195 | 6 | Withdrawn | |
| 012-28102 | 6 | Withdrawn | |
| 012-10007 | 6 | Withdrawn | |
| 012-14190 | 6 | Withdrawn | |
| DKF31/20 | 6 | Withdrawn | |
| 012-S5006 | 6 | Withdrawn | |
| 012-11064 | 6 | Withdrawn | |
| 012-28204 | 6 | Withdrawn | |
| EMF2170 | 5 | Withdrawn | |
| 700500-9900-001 | Withdrawn | ||
| 012-28206 | 6 | Withdrawn | |
| 012-S1193 | Withdrawn | ||
| EMF2125 | 5 | Withdrawn | |
| 012-28112 | 6 | Withdrawn | |
| EM815-3106 | 5 | Withdrawn | |
| DHF25/45-80 | Withdrawn | ||
| 012-15805 | 6 | Withdrawn | |
| 012-28215 | 6 | Withdrawn | |
| 012-14188 | 6 | Withdrawn | |
| 012-S0014 | 6 | Withdrawn | |
| 700511-7000-001 | 2,500 | Withdrawn | |
| 700511-4000-001 | 2,500 | Withdrawn | |
| 012-14185 | 6 | Withdrawn | |
| DKF31/06 | 6 | Withdrawn | |
| 012-14015 | 6 | Withdrawn | |
| 012-26009 | Withdrawn | ||
| 012-S0002 | 6 | Withdrawn | |
| 012-10197 | 6 | Withdrawn | |
| 012-11069 | 6 | Withdrawn | |
| 012-S5005 | 6 | Withdrawn | |
| DKF31/35 | 6 | Withdrawn | |
| EMH254 | 5 | Withdrawn | |
| 012-S4182 | 6 | Withdrawn | |
| 012-10205 | Withdrawn | ||
| 012-28023 | 6 | Withdrawn | |
| 012-11184 | 6 | Withdrawn | |
| DHF21/35 | 6 | Withdrawn | |
| EMH216 | 5 | Withdrawn | |
| 700511-8500-001 | 2,500 | Withdrawn | |
| 012-16022 | 6 | Withdrawn | |
| 700500-1500-001 | 100 | Withdrawn | |
| 012-14083 | 6 | Withdrawn | |
| 012-28208 | 6 | Withdrawn | |
| 012-S1005 | 6 | Withdrawn | |
| 012-S0017 | Withdrawn | ||
| 012-S4062 | 6 | Withdrawn | |
| 012-14201 | 6 | Withdrawn | |
| 012-S4186 | 6 | Withdrawn | |
| 012-28018 | 6 | Withdrawn | |
| 012-16033 | 6 | Withdrawn | |
| EMF2508 | 5 | Withdrawn | |
| DKF25/15-40 | Withdrawn | ||
| DKF31/40 | 6 | Withdrawn | |
| 012-14184 | 6 | Withdrawn | |
| DKF21/10 | 6 | Withdrawn | |
| 012-28205 | 6 | Withdrawn | |
| 012-28002 | 6 | Withdrawn | |
| 012-10068 | 6 | Withdrawn | |
| DHF25/15-40 | Withdrawn | ||
| 012-14078 | 6 | Withdrawn | |
| 700500-2000-001 | 100 | Withdrawn | |
| 012-28111 | 6 | Withdrawn | |
| 012-28115 | 6 | Withdrawn | |
| 012-S4064 | 6 | Withdrawn | |
| 012-14073 | 6 | Withdrawn | |
| 012-14074 | 6 | Withdrawn | |
| 012-S4009 | 6 | Withdrawn | |
| 012-10184 | 6 | Withdrawn | |
| 012-14061 | 6 | Withdrawn | |
| 012-S0061 | 6 | Withdrawn | |
| 012-28307 | 6 | Withdrawn | |
| 012-S4184 | 6 | Withdrawn | |
| 012-10015 | 6 | Withdrawn | |
| 012-10005 | 6 | Withdrawn | |
| EMF2108 | 5 | Withdrawn | |
| 012-10300 | 6 | Withdrawn | |
| 012-28305 | 6 | Withdrawn | |
| DKF25/40 | 6 | Withdrawn | |
| 012-S0182 | 6 | Withdrawn | |
| EM815-3009 | 5 | Withdrawn | |
| 012-15066 | 6 | Withdrawn | |
| 012-28011 | 6 | Withdrawn | |
| 012-14069 | Withdrawn | ||
| DKF21/45-80 | Withdrawn | ||
| 012-10008 | 6 | Withdrawn | |
| 012-S0011 | 6 | Withdrawn | |
| EM815-3103 | 5 | Withdrawn | |
| DKF31/45 | 6 | Withdrawn | |
| 012-11002 | 6 | Withdrawn | |
| 012-15106 | Withdrawn | ||
| 700510-6500-001 | 250 | Withdrawn | |
| 700510-7000-001 | 250 | Withdrawn | |
| DHF21/20 | 6 | Withdrawn | |
| 012-10196 | Withdrawn | ||
| 012-11068 | 6 | Withdrawn | |
| 012-14071 | 6 | Withdrawn | |
| 012-11067 | 6 | Withdrawn | |
| 012-28203 | 6 | Withdrawn | |
| 012-28005 | 6 | Withdrawn | |
| 012-10199 | 6 | Withdrawn | |
| 012-11194 | 6 | Withdrawn | |
| 012-26004 | 6 | Withdrawn | |
| 012-15068 | 6 | Withdrawn | |
| 012-14082 | 6 | Withdrawn | |
| 012-S1000 | 6 | Withdrawn | |
| EMH2510 | 5 | Withdrawn | |
| 012-28103 | 6 | Withdrawn | |
| EMF2555 | 5 | Withdrawn | |
| 017-25504 | 100 | Withdrawn | |
| EMH253 | 5 | Withdrawn | |
| 012-10187 | 6 | Withdrawn | |
| DKF25/20 | 6 | Withdrawn | |
| 012-14010 | Withdrawn | ||
| EMF2510 | 5 | Withdrawn | |
| 700502-9900-001 | Withdrawn | ||
| DKF31/50 | 6 | Withdrawn | |
| EMF2140 | 5 | Withdrawn | |
| 012-S4066 | 6 | Withdrawn | |
| 012-11072 | 6 | Withdrawn | |
| EMH215 | 5 | Withdrawn | |
| 700500-9000-001 | 100 | Withdrawn | |
| EMFSASST25 | 5 | Withdrawn | |
| 012-28028 | Withdrawn | ||
| EMH214 | 5 | Withdrawn | |
| 012-10070 | 6 | Withdrawn | |
| 012-14199 | 6 | Withdrawn | |
| 012-14080 | Withdrawn | ||
| 012-15081 | 6 | Withdrawn | |
| EM815-3107 | 5 | Withdrawn | |
| 012-16014 | Withdrawn | ||
| 012-10002 | 6 | Withdrawn | |
| 012-S5002 | 6 | Withdrawn | |
| 012-15005 | 6 | Withdrawn | |
| 012-14183 | 6 | Withdrawn | |
| EMH213 | 5 | Withdrawn | |
| 012-26010 | Withdrawn | ||
| 012-28110 | 6 | Withdrawn | |
| 012-S0181 | 6 | Withdrawn | |
| DKF25/08 | 6 | Withdrawn | |
| 012-11013 | 6 | Withdrawn | |
| 012-14016 | 6 | Withdrawn | |
| 012-14014 | 6 | Withdrawn | |
| 012-S0064 | 6 | Withdrawn | |
| 012-S0196 | Withdrawn | ||
| 012-10181 | 6 | Withdrawn | |
| 012-S0007 | 6 | Withdrawn | |
| 012-15001 | 6 | Withdrawn | |
| 012-S1004 | 6 | Withdrawn | |
| 012-11063 | 6 | Withdrawn | |
| 012-S4014 | 6 | Withdrawn | |
| 012-10191 | 6 | Withdrawn | |
| 012-15223 | 6 | Withdrawn | |
| 012-15908 | 6 | Withdrawn | |
| 012-S4190 | 6 | Withdrawn | |
| 012-11008 | 6 | Withdrawn | |
| EMASH25 | Withdrawn | ||
| EMH256 | 5 | Withdrawn | |
| 012-S0068 | 6 | Withdrawn | |
| 012-28303 | 6 | Withdrawn | |
| 012-15202 | 6 | Withdrawn | |
| 012-15104 | 6 | Withdrawn | |
| 012-10305 | 6 | Withdrawn | |
| EMF2106 | 5 | Withdrawn | |
| EM815-3225 | Withdrawn | ||
| 012-14004 | 6 | Withdrawn | |
| 012-15063 | 6 | Withdrawn | |
| 012-28027 | 6 | Withdrawn | |
| 012-11059 | 6 | Withdrawn | |
| 012-14062 | 6 | Withdrawn | |
| EMH258 | 5 | Withdrawn | |
| 012-S1060 | 6 | Withdrawn | |
| 012-S6007 | 6 | Withdrawn | |
| 012-11014 | Withdrawn | ||
| 012-11303 | 6 | Withdrawn | |
| 012-16034 | 6 | Withdrawn | |
| 012-28214 | 6 | Withdrawn | |
| 012-S4075 | 6 | Withdrawn | |
| DKF21/30 | 6 | Withdrawn | |
| 012-10003 | 6 | Withdrawn | |
| 012-14189 | Withdrawn | ||
| 012-S0074 | 6 | Withdrawn | |
| 012-14186 | 6 | Withdrawn | |
| 012-S4192 | 6 | Withdrawn | |
| EMFSASST21 | 5 | Withdrawn | |
| EMF2120 | 5 | Withdrawn | |
| DHF25/50 | 6 | Withdrawn | |
| 012-10192 | 6 | Withdrawn | |
| DHF25/45 | 6 | Withdrawn | |
| EMF2540 | 5 | Withdrawn | |
| 012-11185 | 6 | Withdrawn | |
| 012-28020 | 6 | Withdrawn | |
| DHF25/40 | 6 | Withdrawn | |
| 012-S0184 | 6 | Withdrawn | |
| 012-S4013 | 6 | Withdrawn | |
| 012-11073 | Withdrawn | ||
| DHF21/15 | 6 | Withdrawn | |
| 012-S4194 | 6 | Withdrawn | |
| 012-15082 | 6 | Withdrawn | |
| 012-S0015 | 6 | Withdrawn | |
| 012-S6005 | 6 | Withdrawn | |
| DKF31/15-40 | Withdrawn | ||
| 012-14013 | 6 | Withdrawn | |
| 012-14008 | 6 | Withdrawn | |
| 012-14007 | 6 | Withdrawn | |
| 012-S4189 | Withdrawn | ||
| DKF31/08 | 6 | Withdrawn | |
| DKF21/35 | 6 | Withdrawn | |
| DKF25/80 | 6 | Withdrawn | |
| 012-S5064 | 6 | Withdrawn | |
| 012-S5068 | Withdrawn | ||
| 012-16003 | 6 | Withdrawn | |
| 012-S5014 | Withdrawn | ||
| 012-14182 | 6 | Withdrawn | |
| 012-S0062 | 6 | Withdrawn | |
| 012-S0003 | 6 | Withdrawn | |
| 012-10064 | 6 | Withdrawn | |
| 012-15002 | 6 | Withdrawn | |
| 012-14063 | 6 | Withdrawn | |
| 012-14075 | 6 | Withdrawn | |
| 012-S4067 | 6 | Withdrawn | |
| 012-14072 | 6 | Withdrawn | |
| 012-10009 | 6 | Withdrawn | |
| 012-S0012 | 6 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 720 |
| 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.