K162408 is an FDA 510(k) clearance for the Nano Varnish, Plaquit, Lightpaint on Surface. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on April 5, 2018, 584 days after receiving the submission on August 29, 2016.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K162408 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2016 |
| Decision Date | April 05, 2018 |
| Days to Decision | 584 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD - Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |