K240888 is an FDA 510(k) clearance for the Calibra Abutment Resin Cement. 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 April 2, 2024, 1 day after receiving the submission on April 1, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K240888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2024 |
| Decision Date | April 02, 2024 |
| Days to Decision | 1 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |