Caulk® Super Bur®
Caulk® Super Bur® Pear I Bur No. 330 - High Speed
46manufacturers in China registered for this device type
55catalogue 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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EJL |
| Device type | Bur, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3240 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-04-02 |
| Record revised | 2024-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep devices in sterilization packaging in a dry and clean environment. |
| Distribution end date | 2024-05-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 665740 | 10x Burs – Size 556 FG Super Bur | 10 | In distribution |
| 655752 | 10x Burs – Size 699 FG Super Bur | 10 | In distribution |
| 665777 | 10x Burs – Size 35SS FG Super Bur | 10 | In distribution |
| 665753 | 10x Burs – Size 170 FG Super Bur | 10 | In distribution |
| 665731 | 10x Burs – Size 245 FG Super Bur | 10 | In distribution |
| 665710 | Strip of 10 Burs – Round I Bur No. 2 | 10 | In distribution |
| 665944 | 100x Burs – Size 558 FG Super Bur | 100 | In distribution |
| 665760 | 10x Burs – Size 700XXL FG Super Bur | 10 | In distribution |
| 665903 | 100x Burs – Size 2 FG Super Bur | 100 | In distribution |
| 665756 | 10x Burs – Size 700L FG Super Bur | 10 | In distribution |
| 665940 | 100x Burs – Size 556 FG Super Bur | 100 | In distribution |
| 665905 | 100 Burs – Round I Bur No. 4 | 100 | In distribution |
| 665758 | 10x Burs – Size 700XL FG Super Bur | 10 | In distribution |
| 665942 | 100x Burs – Size 557 FG Super Bur | 100 | In distribution |
| 665964 | 100x Burs – Size 701 FG Super Bur | 100 | In distribution |
| 665742 | 10x Burs – Size 557 FG Super Bur | 10 | In distribution |
| 665725 | 10x Burs – Size 330 FG Super Bur | 10 | In distribution |
| 665917 | 100x Burs – Size 6 FG Super Bur | 100 | In distribution |
| 665763 | 10x Burs – Size 171 FG Super Bur | 10 | In distribution |
| 665701 | 10x Burs – Size 1/2 FG Super Bur | 10 | In distribution |
| 665741 | 10x Burs – Size 57 FG Super Bur | 10 | In distribution |
| 665754 | 10x Burs – Size 700 FG Super Bur | 10 | In distribution |
| 665703 | 10x Burs – Size 2 FG Super Bur | 10 | In distribution |
| 665736 | 10x Burs – Size 1558 FG Super Bur | 10 | In distribution |
| 665935 | 100x Burs – Size 1158 FG Super Bur | 100 | In distribution |
| 665775 | 10x Burs – Size 37 FG Super Bur | 10 | In distribution |
| 665772 | 10x Burs – Size 33 1/2 FG Super Bur | 10 | In distribution |
| 665717 | 10x Burs – Size 6 FG Super Bur | 10 | In distribution |
| 665705 | 10x Burs – Size 4 FG Super Bur | 10 | In distribution |
| 665941 | 100x Burs – Size 57 FG Super Bur | 100 | In distribution |
| 665768 | 10x Burs – Size 701XL FG Super Bur | 10 | In distribution |
| 665746 | 10x Burs – Size 557SS FG Super Bur | 10 | In distribution |
| 665735 | 10x Burs – Size 1158 FG Super Bur | 10 | In distribution |
| 665931 | 100x Burs – Size 245 FG Super Bur | 100 | In distribution |
| 665726 | 10x Burs – Size 331 FG Super Bur | 10 | In distribution |
| 665934 | 100x Burs – Size 1157 FG Super Bur | 100 | In distribution |
| 665721 | Strip of 10 Burs – Round I Bur No. 8 | 10 | In distribution |
| 665925 | 100 Burs – Pear I Bur No. 330 | 100 | In distribution |
| 665719 | 10x Burs – Size 8 FG Super Bur | 10 | In distribution |
| 665773 | 10x Burs – Size 34 FG Super Bur | 10 | In distribution |
| 665739 | 10x Burs – Size 56 FG Super Bur | 10 | In distribution |
| 665711 | Strip of 10 Burs – Round I Bur No. 4 | 10 | In distribution |
| 665751 | 10x Burs – Size 169 FG Super Bur | 10 | In distribution |
| 665708 | 10x Burs – Size 4SS FG Super Bur | 10 | In distribution |
| 665700 | 10x Burs – Size 1/4 FG Super Bur | 10 | In distribution |
| 665728 | 10x Burs – Size 330SS FG Super Bur | 10 | In distribution |
| 665702 | 10x Burs – Size 1 FG Super Bur | 10 | In distribution |
| 665764 | 10x Burs – Size 701 FG Super Bur | 10 | In distribution |
| 665744 | 10x Burs – Size 558 FG Super Bur | 10 | In distribution |
| 665732 | 10x Burs – Size 1156 FG Super Bur | 10 | In distribution |
| 665720 | Strip of 10 Burs – Round I Bur No. 6 | 10 | In distribution |
| 665734 | 10x Burs – Size 1557 FG Super Bur | 10 | Withdrawn |
| 665733 | 10x Burs – Size 1157 FG Super Bur | 10 | Withdrawn |
| 665766 | 10x Burs – Size 701L FG Super Bur | 10 | Withdrawn |
| 665774 | 10x Burs – Size 35 FG Super Bur | 10 | Withdrawn |
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.