K151996 is an FDA 510(k) clearance for the TAURUS C1. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Shinhung Company, Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 22, 2016, 186 days after receiving the submission on July 20, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K151996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 2015 |
| Decision Date | January 22, 2016 |
| Days to Decision | 186 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA - Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |