Submission Details
| 510(k) Number | K063624 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2006 |
| Decision Date | February 08, 2007 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
K063624 is an FDA 510(k) clearance for the KAVO EVEREST C-TEMP, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Kavo America (Deer Field, US). The FDA issued a Cleared decision on February 8, 2007, 64 days after receiving the submission on December 6, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K063624 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 06, 2006 |
| Decision Date | February 08, 2007 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3770 |