K-Files
86 catalogue numbers from N050 L25, listed by Micro-Mega SA, France, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
86catalogue 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 | Micro-Mega SA, France |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-12-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Box of 10, grouping box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N050 L25 | 6 | In distribution | |
| N040 L21 | 6 | In distribution | |
| N010 L25 | 6 | In distribution | |
| N008/015 L31 | In distribution | ||
| N090 L31 | 6 | In distribution | |
| N090/140 L21 | In distribution | ||
| n008 L21 | 6 | In distribution | |
| n015 L21 | 6 | In distribution | |
| N006 L21 | 6 | In distribution | |
| N020 L25 | 6 | In distribution | |
| N070 L25 | 6 | In distribution | |
| n008 L25 | 6 | In distribution | |
| N070 L31 | 6 | In distribution | |
| N050 L31 | 6 | In distribution | |
| N008/015 L21 | In distribution | ||
| n010 L25 | 6 | In distribution | |
| N060 L31 | 6 | In distribution | |
| N030 L21 | 6 | In distribution | |
| N015/040 L31 | In distribution | ||
| N055 L25 | 6 | In distribution | |
| N020 L31 | 6 | In distribution | |
| N045/080 L21 | In distribution | ||
| N055 L21 | 6 | In distribution | |
| N045/080 L25 | In distribution | ||
| N006 L25 | 6 | In distribution | |
| N015 L21 | 6 | In distribution | |
| N140 L25 | 6 | In distribution | |
| N015 L25 | 6 | In distribution | |
| N006 L31 | 6 | In distribution | |
| N045/080 L31 | In distribution | ||
| N015/040 L21 | In distribution | ||
| N140 L21 | 6 | In distribution | |
| N120 L21 | 6 | In distribution | |
| N025 L31 | 6 | In distribution | |
| N110 L31 | 6 | In distribution | |
| N090 L21 | 6 | In distribution | |
| N130 L31 | 6 | In distribution | |
| N100 L25 | 6 | In distribution | |
| N008 L31 | 6 | In distribution | |
| N040 L31 | 6 | In distribution | |
| N080 L25 | 6 | In distribution | |
| n025 L25 | 6 | In distribution | |
| N070 L21 | 6 | In distribution | |
| N025 L25 | 6 | In distribution | |
| n008 L25 | 6 | In distribution | |
| N100 L21 | 6 | In distribution | |
| N030 L31 | 6 | In distribution | |
| n020 L21 | 6 | In distribution | |
| N045 L21 | 6 | In distribution | |
| N010 L31 | 6 | In distribution | |
| n020 L25 | 6 | In distribution | |
| N090 L25 | 6 | In distribution | |
| N025 L21 | 6 | In distribution | |
| N040 L25 | 6 | In distribution | |
| N100 L31 | 6 | In distribution | |
| n010 L21 | 6 | In distribution | |
| N035 L21 | 6 | In distribution | |
| N120 L31 | 6 | In distribution | |
| n006 L25 | 6 | In distribution | |
| N010 L21 | 6 | In distribution | |
| N110 L25 | 6 | In distribution | |
| N045 L25 | 6 | In distribution | |
| N008/015 L25 | In distribution | ||
| n040 L25 | 6 | In distribution | |
| N080 L31 | 6 | In distribution | |
| N030 L25 | 6 | In distribution | |
| N050 L21 | 6 | In distribution | |
| N045 L31 | 6 | In distribution | |
| N090/140 L25 | In distribution | ||
| N140 L31 | 6 | In distribution | |
| N060 L21 | 6 | In distribution | |
| N080 L21 | 6 | In distribution | |
| N130 L25 | 6 | In distribution | |
| N110 L21 | 6 | In distribution | |
| N060 L25 | 6 | In distribution | |
| N120 L25 | 6 | In distribution | |
| n006 L21 ISO M09 | 6 | In distribution | |
| N055 L31 | 6 | In distribution | |
| N015 L31 | 6 | In distribution | |
| N130 L21 | 6 | In distribution | |
| N020 L21 | 6 | In distribution | |
| N035 L25 | 6 | In distribution | |
| n015 L25 | 6 | In distribution | |
| N035 L31 | 6 | In distribution | |
| N090/140 L31 | In distribution | ||
| n008 L21 | 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 |
|---|---|
| K970649 | 1997-05-16 |
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.