K182778 is an FDA 510(k) clearance for the LC GLOSSFILL XR. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by S&C Polymer Silicon- Und Composite Spezialitaeten GmbH (Elmshorn, DE). The FDA issued a Cleared decision on April 22, 2019, 203 days after receiving the submission on October 1, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K182778 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2018 |
| Decision Date | April 22, 2019 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |