K193260 is an FDA 510(k) clearance for the U-Cem Premium & MAZIC Cem. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Vericom Co., Ltd. (Chuncheon-Si, KR). The FDA issued a Cleared decision on August 21, 2020, 269 days after receiving the submission on November 26, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K193260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 2019 |
| Decision Date | August 21, 2020 |
| Days to Decision | 269 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 |