K183380 is an FDA 510(k) clearance for the Tetric PowerFill. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on March 14, 2019, 98 days after receiving the submission on December 6, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K183380 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 2018 |
| Decision Date | March 14, 2019 |
| Days to Decision | 98 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |