K163613 is an FDA 510(k) clearance for the Bluephase Style 20i. 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 April 4, 2017, 103 days after receiving the submission on December 22, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K163613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2016 |
| Decision Date | April 04, 2017 |
| Days to Decision | 103 days |
| Submission Type | Abbreviated |
| 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 |