K915619 is an FDA 510(k) clearance for the IONOFIL/LONOFIL MOLAR. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Voco GmbH (Denver, US). The FDA issued a Cleared decision on February 25, 1992, 71 days after receiving the submission on December 16, 1991.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K915619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1991 |
| Decision Date | February 25, 1992 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |