K190272 is an FDA 510(k) clearance for the Bluephase PowerCure. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on July 3, 2019, 145 days after receiving the submission on February 8, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K190272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2019 |
| Decision Date | July 03, 2019 |
| Days to Decision | 145 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 |