K112078 is an FDA 510(k) clearance for the ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE). This device is classified as a Resin, Root Canal Filling (Class II - Special Controls, product code KIF).
Submitted by Maruchi (Fullerton, US). The FDA issued a Cleared decision on March 19, 2012, 242 days after receiving the submission on July 21, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3820.
| 510(k) Number | K112078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 21, 2011 |
| Decision Date | March 19, 2012 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | KIF - Resin, Root Canal Filling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3820 |