Brasseler USA
LS 1L 1:1 Contra Angle 1P
9manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Record published | 2022-12-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5021305U0 | In distribution | |
| 5027608U0 | In distribution | |
| 5021300U0 | In distribution | |
| 5021285U0 | In distribution | |
| 5021409U0 | In distribution | |
| 5028348U0 | In distribution | |
| 5021294U0 | In distribution | |
| 5030743U0 | In distribution | |
| 5030744U0 | In distribution | |
| 5021296U0 | In distribution | |
| 5021292U0 | In distribution | |
| 5028352U0 | In distribution | |
| 5028349U0 | In distribution | |
| 5021290U0 | In distribution | |
| 5030742U0 | In distribution | |
| 5021298U0 | In distribution | |
| 5028351U0 | In distribution | |
| 5021301U0 | In distribution | |
| 5027609U0 | In distribution | |
| 5021288U0 | In distribution | |
| 5028350U0 | In distribution | |
| 5021302U0 | In distribution | |
| 5028353U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Premium Plus | Premium Plus International Limited | 366 |
| Young | Young Dental Manufacturing I, LLC | 94 |
| Henry Schein | Henry Schein, Inc. | 84 |
| StarDental Instrument Solutions | Dentalez, Inc. | 63 |
| Maxso | Beyes Dental Canada, Inc. | 42 |
| Nupro® | Dentsply Professional | 35 |
| AllPro | Team Technologies, Inc. | 30 |
| Medidenta | Medidenta | 28 |
| Maxima | Henry Schein, Inc. | 21 |
| Denticator | Young Dental Manufacturing I, LLC | 19 |
| Henry Schein | Young Dental Manufacturing I, LLC | 17 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, 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.