K190339 is an FDA 510(k) clearance for the Helioseal F Plus. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on July 29, 2019, 165 days after receiving the submission on February 14, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K190339 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2019 |
| Decision Date | July 29, 2019 |
| Days to Decision | 165 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |