K073209 is an FDA 510(k) clearance for the MAXCEM 2. This device is classified as a Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief (Class II - Special Controls, product code MZW).
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on January 29, 2008, 76 days after receiving the submission on November 14, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K073209 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 14, 2007 |
| Decision Date | January 29, 2008 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MZW — Dental Cement W/out Zinc-oxide Eugenol As An Ulcer Covering For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |