K182854 is an FDA 510(k) clearance for the GC FujiCEM 2 (Improved). 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 July 11, 2019, 274 days after receiving the submission on October 10, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K182854 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 2018 |
| Decision Date | July 11, 2019 |
| Days to Decision | 274 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 |