K163064 is an FDA 510(k) clearance for the Demi Ultra. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on July 18, 2017, 258 days after receiving the submission on November 2, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K163064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 2016 |
| Decision Date | July 18, 2017 |
| Days to Decision | 258 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 |