K081405 is an FDA 510(k) clearance for the XERACEM. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Doxa Dental AB (Washington, US). The FDA issued a Cleared decision on August 21, 2008, 94 days after receiving the submission on May 19, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K081405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2008 |
| Decision Date | August 21, 2008 |
| Days to Decision | 94 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA - Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |