K160551 is an FDA 510(k) clearance for the VALO Grand. 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 July 13, 2016, 135 days after receiving the submission on February 29, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K160551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 29, 2016 |
| Decision Date | July 13, 2016 |
| Days to Decision | 135 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 |