K192530 is an FDA 510(k) clearance for the Surefil one Self-adhesive Composite Hybrid. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on January 23, 2020, 129 days after receiving the submission on September 16, 2019.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K192530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2019 |
| Decision Date | January 23, 2020 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |