Oktagon®
Rotary instrument für surgical application
46manufacturers in China registered for this device type
47catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Shanghai (8), Jiangsu (5). 3 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 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai MU Promotions Co., Ltd. | Shanghai | Shanghai | Exporter | 62 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
Showing 12 of 46. All 46 manufacturers in China registered for Bur, Dental
Record
| Listed by | Hager & Meisinger Gesellschaft mit beschränkter Haftung |
|---|---|
| FDA product code | EJL |
| Device type | Bur, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3240 |
| Premarket notification | Exempt |
| Record published | 2021-09-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 37132 | In distribution | |
| 38130 | In distribution | |
| 11594 | In distribution | |
| 38152 | In distribution | |
| 38137 | In distribution | |
| 22139 | In distribution | |
| 38180 | In distribution | |
| 82762 | In distribution | |
| 23018 | In distribution | |
| 38120 | In distribution | |
| 22140 | In distribution | |
| 24024 | In distribution | |
| 38136 | In distribution | |
| 23017 | In distribution | |
| 31061 | In distribution | |
| 24019 | In distribution | |
| 24017 | In distribution | |
| 38131 | In distribution | |
| 24010 | In distribution | |
| 93740 | In distribution | |
| 24021 | In distribution | |
| 24014 | In distribution | |
| 24015 | In distribution | |
| 38132 | In distribution | |
| 24011 | In distribution | |
| 38147 | In distribution | |
| 93738 | In distribution | |
| 24013 | In distribution | |
| 24022 | In distribution | |
| 23016 | In distribution | |
| 24012 | In distribution | |
| 24023 | In distribution | |
| 37137 | In distribution | |
| 38121 | In distribution | |
| 24016 | In distribution | |
| 92738 | In distribution | |
| 23019 | In distribution | |
| 38153 | In distribution | |
| 31863 | In distribution | |
| 24018 | In distribution | |
| 38148 | In distribution | |
| 38151 | In distribution | |
| 31862 | In distribution | |
| 38135 | In distribution | |
| 38149 | In distribution | |
| 37147 | In distribution | |
| 31861 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Tungsten Carbide Dental Burs | M.D.T. – Micro Diamond Technologies Ltd. | 1,795 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 1,719 |
| Bur, Dental | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 1,458 |
| Edenta | Edenta Etablissement | 1,415 |
| Alpen | Coltene/Whaledent Gmbh & Co. KG | 1,243 |
| Komet Dental Tungsten Carbide Burs | Gebr. Brasseler Gmbh & Co. KG | 760 |
| Henry Schein | Henry Schein, Inc. | 665 |
| House Brand Dentistry | Frontier Dental Supply Inc | 659 |
| SSW Carbide | SS White Burs LLC | 610 |
| Sabur By 3D Dental | 3D Dental Designs AND Development, LLC | 530 |
| Beyes | Beyes Dental Canada, Inc. | 509 |
| Johnson-Promident | Young Innovations Inc. | 439 |
Showing 12 of 2,159. All products under Bur, Dental
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.