K063529 is an FDA 510(k) clearance for the PENCURE, MODEL VL-7. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on January 5, 2007, 44 days after receiving the submission on November 22, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K063529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 22, 2006 |
| Decision Date | January 05, 2007 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBZ — Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |