K183476 is an FDA 510(k) clearance for the 3M Filtek Universal Restorative. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by 3M Espe Dental Products (Saint Paul, US). The FDA issued a Cleared decision on January 2, 2019, 16 days after receiving the submission on December 17, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K183476 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2018 |
| Decision Date | January 02, 2019 |
| Days to Decision | 16 days |
| Submission Type | Traditional |
| 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 |