K153174 is an FDA 510(k) clearance for the Ketac Universal Aplicap. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by 3M Deutschland GmbH (Seefeld, DE). The FDA issued a Cleared decision on April 13, 2016, 162 days after receiving the submission on November 3, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K153174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2015 |
| Decision Date | April 13, 2016 |
| Days to Decision | 162 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 |