Traus Dental Handpiece
Traus CRB46 dental handpieces are gear-driven instruments used with torque-adjustable electric motors during dental surgery. Their applications include preparing implant sites, contouring…
Traus CRB46 dental handpieces are gear-driven instruments used with torque-adjustable electric motors during dental surgery. Their applications include preparing implant sites, contouring bone, periodontal procedures, bone grafting and sectioning or removing teeth.
A twenty-to-one gear reduction transfers motor rotation to the working instrument at a lower speed. The contra-angle handpiece attaches through an ISO 3964 coupling, and its head clamp holds a compatible instrument shank.
Listed Item
20:1, Non-Optic
Instrument Interface
The handpiece uses a push-button locking chuck for instruments conforming to ISO 1797-1. With a maximum input of 40,000 revolutions per minute, the reduced output speed is 2,000 revolutions per minute.
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 | Saeshin Precision Co., Ltd., South Korea |
|---|---|
| FDA product code | EGS |
| Device type | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K182892 |
| Record published | 2020-12-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRAUS CRB46LN | In distribution | |
| TRAUS CRB46NN | 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 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 23 |
| Maxima | Henry Schein, Inc. | 21 |
| Denticator | Young Dental Manufacturing I, LLC | 19 |
| Henry Schein | Young Dental Manufacturing I, LLC | 17 |
Showing 12 of 247. All products under Handpiece, Contra- And Right-Angle Attachment, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182892 | 2019-11-26 |
| K181129 | 2019-01-31 |
| K171436 | 2018-01-05 |
| K143418 | 2015-07-31 |
| K100192 | 2010-02-04 |
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.