Brasseler USA
702L FG TAP Fiss H33L.31.016 1P
46manufacturers in China registered for this device type
1,719catalogue 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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EJL |
| Device type | Bur, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3240 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2024-08-13 (version 4) |
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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5027867U0 | In distribution | |
| 015999U0 | In distribution | |
| 000396T0 | In distribution | |
| 001297U0 | In distribution | |
| 000491U3 | In distribution | |
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| 000087U9 | In distribution | |
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| 5023873S0 | In distribution | |
| 000091SP | In distribution | |
| 000091U5 | In distribution | |
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| 5020940U1 | In distribution | |
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| 002748G3 | In distribution | |
| 000453U4 | In distribution | |
| 000108SP | In distribution | |
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| 000535U0 | In distribution | |
| 000296U7 | In distribution | |
| 000677T0 | In distribution | |
| 000733SP | In distribution | |
| 5012481U2 | In distribution | |
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| 011810U2 | In distribution | |
| 000024S1 | In distribution | |
| 000340U0 | In distribution | |
| 000114G0 | In distribution | |
| 017365U1 | In distribution | |
| 015260U2 | In distribution | |
| 001107U4 | In distribution | |
| 001149S1 | In distribution | |
| 5030158U0 | In distribution | |
| 013746T0 | In distribution | |
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| 017374U0 | In distribution | |
| 006634U1 | In distribution | |
| 001381U0 | In distribution | |
| 5027873U0 | In distribution | |
| 000104SP | In distribution | |
| 000494U0 | In distribution | |
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| 000936U1 | In distribution | |
| 5027859U0 | In distribution | |
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MDT Tungsten Carbide Dental Burs | M.D.T. – Micro Diamond Technologies Ltd. | 1,795 |
| 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 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 423 |
Showing 12 of 2,159. All products under Bur, Dental
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Brasseler U.S.A. Dental, LLC | UDI-DI | 2024-01-11 | Class II | Under Investigation by firm | The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. | 440 burs |
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.