K081913 is an FDA 510(k) clearance for the METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Meta Biomed Co., Ltd. (Cheung Ju City, Chung Buk, KR). The FDA issued a Cleared decision on September 5, 2008, 64 days after receiving the submission on July 3, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K081913 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 03, 2008 |
| Decision Date | September 05, 2008 |
| Days to Decision | 64 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 |