K083647 is an FDA 510(k) clearance for the VALO, MODEL 5919. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on January 23, 2009, 45 days after receiving the submission on December 9, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K083647 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2008 |
| Decision Date | January 23, 2009 |
| Days to Decision | 45 days |
| Submission Type | Special |
| 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 |