Cleared Traditional

Nano Varnish, Plaquit, Lightpaint on Surface

K162408 · Dreve Dentamid GmbH · Dental
Apr 2018
Decision
584d
Days
Class 2
Risk

About This 510(k) Submission

K162408 is an FDA 510(k) clearance for the Nano Varnish, Plaquit, Lightpaint on Surface, 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 review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number K162408 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EBD — Coating, Filling Material, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3310