Traus SIP20
TRAUS SIP20 powers dental handpieces for dental surgery and implant procedures, including work on dental hard tissue and rotating root canal preparation. The system combines a control box,…
TRAUS SIP20 powers dental handpieces for dental surgery and implant procedures, including work on dental hard tissue and rotating root canal preparation. The system combines a control box, electrical micromotor, contra angle handpiece and foot controller. It is a prescription dental device.
The motor and internal gears turn the instrument held in the handpiece. The control box and foot controller regulate speed and direction. The listed configuration includes the BIP20 control box, MBP10SL motor, FUS10 foot controller and CRB46LN handpiece.
Listed Item
BIP20+MBP10SL+FUS10+CRB46LN
Handpiece Configuration
The CRB46LN uses a 20 to 1 reduction ratio and has fibre optic illumination. Its specified maximum speed is 2,000 revolutions per minute, with a type 1 instrument shank connection.
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Saeshin Precision Co., Ltd., South Korea |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K201292 |
| Record published | 2021-02-22 |
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 SIP20#1 | In distribution | |
| TRAUS BIP20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A-dec | A-dec, Inc. | 43 |
| X-Cube | Saeshin Precision Co., Ltd. | 22 |
| Maxso | Beyes Dental Canada, Inc. | 20 |
| NLZ | Nakanishi Inc. | 16 |
| Surgic Pro | Nakanishi Inc. | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 11 |
| woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 10 |
| NL400 | Nakanishi Inc. | 9 |
| NLX | Nakanishi Inc. | 9 |
| Surgic XT Plus | Nakanishi Inc. | 6 |
| Axiom® | Etablissements Anthogyr | 6 |
Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251407 | 2026-01-30 |
| K201292 | 2021-02-11 |
| K092758 | 2009-09-21 |
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.