K112307 is an FDA 510(k) clearance for the RESIGLASS PASTE. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on March 28, 2012, 230 days after receiving the submission on August 11, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K112307 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2011 |
| Decision Date | March 28, 2012 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |