Komet Root Canal Files
199 catalogue numbers from FQ06L21.204.030.G1, listed by Gebr. Brasseler Gmbh & Co. KG, Germany, under File, Pulp Canal, Endodontic. 53 manufacturers in China are registered for this product code.
53manufacturers in China registered for this device type
199catalogue 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 | Gebr. Brasseler Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-04-06 |
| Record revised | 2023-03-10 (version 2) |
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 |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| FQ06L21.204.030.G1 | 6 | In distribution | |
| 17325.654.006.A3 | 6 | In distribution | |
| 17425.654.045.A3 | 6 | In distribution | |
| 17425.654.015.A3 | 6 | In distribution | |
| 17331.654.030.R1 | 6 | In distribution | |
| 17421.654.025.A3 | 6 | In distribution | |
| 17421.654.035.A3 | 6 | In distribution | |
| F04L21.204.045.G1 | 6 | In distribution | |
| F04L31.204.055.G1 | 6 | In distribution | |
| OP10L19.204.030.G1 | 6 | In distribution | |
| FQ04L31.204.030.G1 | 6 | In distribution | |
| PRQ6L21.204.030.G1 | 6 | In distribution | |
| FQ04L21.204.045.G1 | 6 | In distribution | |
| F06L25.204.025.G1 | 6 | In distribution | |
| 17325.654.020.A3 | 6 | In distribution | |
| PRQ6L31.204.020.G1 | 6 | In distribution | |
| PRQ6L21.204.025.G1 | 6 | In distribution | |
| 17325.654.006.R1 | 6 | In distribution | |
| 17431.654.025.A3 | 6 | In distribution | |
| 17331.654.060.A3 | 6 | In distribution | |
| FQ06L31.204.025.G1 | 6 | In distribution | |
| 17431.654.040.A3 | 6 | In distribution | |
| 17321.654.008.R1 | 6 | In distribution | |
| FQ04L25.204.045.G1 | 6 | In distribution | |
| F04L21.204.055.G1 | 6 | In distribution | |
| PG03L31.204.020.G1 | 6 | In distribution | |
| F06L21.204.030.G1 | 6 | In distribution | |
| PRQ4L25.204.050.G1 | 6 | In distribution | |
| PRQ6L25.204.025.G1 | 6 | In distribution | |
| 17331.654.020.A3 | 6 | In distribution | |
| 17425.654.050.A3 | 6 | In distribution | |
| PRQ6L31.204.025.G1 | 6 | In distribution | |
| RE05L25.204.025.G1 | 6 | In distribution | |
| F06L25.204.040.G1 | 6 | In distribution | |
| 17331.654.010.R1 | 6 | In distribution | |
| 17431.654.060.A3 | 6 | In distribution | |
| 17321.654.035.A3 | 6 | In distribution | |
| 17331.654.015.A3 | 6 | In distribution | |
| FQ04L21.204.055.G1 | 6 | In distribution | |
| 17521.654.010.R1 | 6 | In distribution | |
| F04L21.204.025.G1 | 6 | In distribution | |
| PG03L21.204.015.G1 | 6 | In distribution | |
| 17331.654.010.A3 | 6 | In distribution | |
| 17431.654.035.A3 | 6 | In distribution | |
| 17431.654.030.A3 | 6 | In distribution | |
| 17325.654.015.A3 | 6 | In distribution | |
| 17425.654.025.A3 | 6 | In distribution | |
| 17321.654.060.A3 | 6 | In distribution | |
| 17521.654.012.R1 | 6 | In distribution | |
| PRQ4L31.204.045.G1 | 6 | In distribution | |
| 17331.654.035.R1 | 6 | In distribution | |
| 17321.654.020.R1 | 6 | In distribution | |
| RE05L21.204.025.G1 | 6 | In distribution | |
| 17331.654.006.A3 | 6 | In distribution | |
| 17331.654.008.A3 | 6 | In distribution | |
| 17331.654.008.R1 | 6 | In distribution | |
| FQ04L25.204.030.G1 | 6 | In distribution | |
| F06L25.204.035.G1 | 6 | In distribution | |
| FQ04L21.204.025.G1 | 6 | In distribution | |
| 17331.654.035.A3 | 6 | In distribution | |
| F06L31.204.030.G1 | 6 | In distribution | |
| PRQ5L25.204.035.G1 | 6 | In distribution | |
| 17425.654.020.A3 | 6 | In distribution | |
| AK10L19.204.035.A2 | 5 | In distribution | |
| F04L25.204.035.G1 | 6 | In distribution | |
| FQ06L25.204.020.G1 | 6 | In distribution | |
| RE10L15.204.030.G1 | 6 | In distribution | |
| FQ06L31.204.030.G1 | 6 | In distribution | |
| FQ08L19.204.020.G1 | 6 | In distribution | |
| 17431.654.045.A3 | 6 | In distribution | |
| 17325.654.040.A3 | 6 | In distribution | |
| 17421.654.055.A3 | 6 | In distribution | |
| 17421.654.015.A3 | 6 | In distribution | |
| 17325.654.012.R1 | 6 | In distribution | |
| 17431.654.055.A3 | 6 | In distribution | |
| 17321.654.025.A3 | 6 | In distribution | |
| FQ04L21.204.035.G1 | 6 | In distribution | |
| FQ04L25.204.025.G1 | 6 | In distribution | |
| 17321.654.055.A3 | 6 | In distribution | |
| 17425.654.040.A3 | 6 | In distribution | |
| 17421.654.050.A3 | 6 | In distribution | |
| 17321.654.030.A3 | 6 | In distribution | |
| 17425.654.055.A3 | 6 | In distribution | |
| F06L31.204.020.G1 | 6 | In distribution | |
| 17325.654.055.A3 | 6 | In distribution | |
| FQ04L25.204.020.G1 | 6 | In distribution | |
| 17521.654.008.R1 | 6 | In distribution | |
| 17425.654.035.A3 | 6 | In distribution | |
| 17321.654.006.A3 | 6 | In distribution | |
| 17421.654.045.A3 | 6 | In distribution | |
| 17331.654.050.A3 | 6 | In distribution | |
| 17321.654.040.A3 | 6 | In distribution | |
| FQ04L31.204.035.G1 | 6 | In distribution | |
| FQ06L21.204.025.G1 | 6 | In distribution | |
| 17321.654.025.R1 | 6 | In distribution | |
| PG03L31.204.015.G1 | 6 | In distribution | |
| 17431.654.020.A3 | 6 | In distribution | |
| FQ04L31.204.025.G1 | 6 | In distribution | |
| F06L25.204.030.G1 | 6 | In distribution | |
| 17331.654.015.R1 | 6 | In distribution | |
| F06L31.204.035.G1 | 6 | In distribution | |
| F06L31.204.025.G1 | 6 | In distribution | |
| 17321.654.008.A3 | 6 | In distribution | |
| 17421.654.060.A3 | 6 | In distribution | |
| 17321.654.015.R1 | 6 | In distribution | |
| F06L21.204.020.G1 | 6 | In distribution | |
| F06L31.204.040.G1 | 6 | In distribution | |
| 17325.654.060.A3 | 6 | In distribution | |
| PRQ5L25.204.040.G1 | 6 | In distribution | |
| 17325.654.010.R1 | 6 | In distribution | |
| 17331.654.025.R1 | 6 | In distribution | |
| PRQ6L25.204.030.G1 | 6 | In distribution | |
| 17421.654.030.A3 | 6 | In distribution | |
| FQ06L21.204.020.G1 | 6 | In distribution | |
| FQ03L31.204.015.G1 | 6 | In distribution | |
| 17321.654.010.R1 | 6 | In distribution | |
| 17325.654.035.A3 | 6 | In distribution | |
| 17331.654.045.A3 | 6 | In distribution | |
| 17331.654.020.R1 | 6 | In distribution | |
| 17325.654.030.R1 | 6 | In distribution | |
| FQ03L21.204.015.G1 | 6 | In distribution | |
| 17325.654.010.A3 | 6 | In distribution | |
| OPR08L19.204.025.G1 | 6 | In distribution | |
| 17321.654.012.R1 | 6 | In distribution | |
| 17431.654.015.A3 | 6 | In distribution | |
| OP08L19.204.025.G1 | 6 | In distribution | |
| 17421.654.020.A3 | 6 | In distribution | |
| OPR10L19.204.030.G1 | 6 | In distribution | |
| 17321.654.010.A3 | 6 | In distribution | |
| FQ04L25.204.035.G1 | 6 | In distribution | |
| 17325.654.025.R1 | 6 | In distribution | |
| F06L21.204.035.G1 | 6 | In distribution | |
| 17325.654.008.A3 | 6 | In distribution | |
| F04L25.204.045.G1 | 6 | In distribution | |
| PRQ4L25.204.045.G1 | 6 | In distribution | |
| 17425.654.030.A3 | 6 | In distribution | |
| 17431.654.050.A3 | 6 | In distribution | |
| 17321.654.015.A3 | 6 | In distribution | |
| 17331.654.040.A3 | 6 | In distribution | |
| FQ04L31.204.055.G1 | 6 | In distribution | |
| PRQ4L31.204.050.G1 | 6 | In distribution | |
| 17325.654.025.A3 | 6 | In distribution | |
| FQ04L25.204.055.G1 | 6 | In distribution | |
| FQ04L21.204.030.G1 | 6 | In distribution | |
| FQ04L31.204.045.G1 | 6 | In distribution | |
| 17321.654.006.R1 | 6 | In distribution | |
| PRQ4L21.204.045.G1 | 6 | In distribution | |
| 17321.654.045.A3 | 6 | In distribution | |
| 17321.654.030.R1 | 6 | In distribution | |
| 17421.654.040.A3 | 6 | In distribution | |
| F04L25.204.055.G1 | 6 | In distribution | |
| F04L21.204.035.G1 | 6 | In distribution | |
| FQ03L25.204.015.G1 | 6 | In distribution | |
| 17525.654.012.R1 | 6 | In distribution | |
| 17325.654.020.R1 | 6 | In distribution | |
| 17425.654.060.A3 | 6 | In distribution | |
| 17321.654.020.A3 | 6 | In distribution | |
| PRQ6L25.204.020.G1 | 6 | In distribution | |
| 17525.654.015.R1 | 6 | In distribution | |
| 17325.654.015.R1 | 6 | In distribution | |
| 17521.654.006.R1 | 6 | In distribution | |
| FQ06L31.204.020.G1 | 6 | In distribution | |
| 17525.654.010.R1 | 6 | In distribution | |
| 17521.654.015.R1 | 6 | In distribution | |
| 17325.654.035.R1 | 6 | In distribution | |
| FQ04L31.204.020.G1 | 6 | In distribution | |
| OP10L15.204.030.G1 | 6 | In distribution | |
| F06L25.204.020.G1 | 6 | In distribution | |
| 17331.654.012.R1 | 6 | In distribution | |
| FQ06L25.204.030.G1 | 6 | In distribution | |
| F04L31.204.035.G1 | 6 | In distribution | |
| 17331.654.025.A3 | 6 | In distribution | |
| F04L31.204.025.G1 | 6 | In distribution | |
| F04L31.204.045.G1 | 6 | In distribution | |
| PRQ6L31.204.030.G1 | 6 | In distribution | |
| 17525.654.006.R1 | 6 | In distribution | |
| F04L25.204.025.G1 | 6 | In distribution | |
| 17331.654.006.R1 | 6 | In distribution | |
| 17321.654.050.A3 | 6 | In distribution | |
| 17331.654.030.A3 | 6 | In distribution | |
| 17325.654.030.A3 | 6 | In distribution | |
| 17325.654.050.A3 | 6 | In distribution | |
| PG03L25.204.020.G1 | 6 | In distribution | |
| 17325.654.008.R1 | 6 | In distribution | |
| PRQ5L31.204.040.G1 | 6 | In distribution | |
| PG03L25.204.015.G1 | 6 | In distribution | |
| PG03L21.204.020.G1 | 6 | In distribution | |
| PRQ5L21.204.040.G1 | 6 | In distribution | |
| PRQ4L21.204.050.G1 | 6 | In distribution | |
| PRQ5L31.204.035.G1 | 6 | In distribution | |
| 17331.654.055.A3 | 6 | In distribution | |
| 17325.654.045.A3 | 6 | In distribution | |
| F06L21.204.040.G1 | 6 | In distribution | |
| F06L21.204.025.G1 | 6 | In distribution | |
| FQ04L21.204.020.G1 | 6 | In distribution | |
| 17525.654.008.R1 | 6 | In distribution | |
| FQ06L25.204.025.G1 | 6 | In distribution | |
| PRQ6L21.204.020.G1 | 6 | In distribution | |
| PRQ5L21.204.035.G1 | 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 |
| 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.