K123695 is an FDA 510(k) clearance for the TRAUS SIP10. This device is classified as a Handpiece, Water-powered (Class I - General Controls, product code EKY).
Submitted by Saeshin Precision Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on December 18, 2012, 15 days after receiving the submission on December 3, 2012.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K123695 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2012 |
| Decision Date | December 18, 2012 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EKY - Handpiece, Water-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |