K161256 is an FDA 510(k) clearance for the TheraCem. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on July 29, 2016, 86 days after receiving the submission on May 4, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K161256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2016 |
| Decision Date | July 29, 2016 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |