K053040 is an FDA 510(k) clearance for the PARACEM UNIVERSAL DC. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Coltene/Whaledent AG (New York, US). The FDA issued a Cleared decision on November 9, 2005, 13 days after receiving the submission on October 27, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K053040 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2005 |
| Decision Date | November 09, 2005 |
| Days to Decision | 13 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 |