K060881 is an FDA 510(k) clearance for the TEMPORARY CROWN & BRIDGE RESIN. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on May 16, 2006, 46 days after receiving the submission on March 31, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K060881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2006 |
| Decision Date | May 16, 2006 |
| Days to Decision | 46 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 |