K984505 is an FDA 510(k) clearance for the MIRACLE MIX POWDER/LIQUID. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on February 4, 1999, 48 days after receiving the submission on December 18, 1998.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K984505 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 1998 |
| Decision Date | February 04, 1999 |
| Days to Decision | 48 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 |