Cleared Traditional

K162408 - Nano Varnish, Plaquit, Lightpaint on Surface (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162408 · Dreve Dentamid GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2018
Decision
584d
Days
Class 2
Risk

K162408 is an FDA 510(k) clearance for the Nano Varnish, Plaquit, Lightpaint on Surface. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Dreve Dentamid GmbH (Unna, DE). The FDA issued a Cleared decision on April 5, 2018 after a review of 584 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dreve Dentamid GmbH devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
457d slower than avg
Panel avg: 127d · This submission: 584d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBD Coating, Filling Material, Resin

All 51
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K162408.
GLOSSY COAT (15ML)
K254091 · YAMAHACHI DENTAL MFG., Co. · Apr 2026
ID LIGHT CURE SYSTEM
K250804 · Id Korea Co., Ltd. · Jun 2025
visio.lign color, visio.lign shield
K240735 · Bredent GmbH & Co. KG · Dec 2024
RODIN Palette Naturalizing Kit
K223365 · Belport Company, Inc., Gingi-Pak · Mar 2023
VITA Akzent LC
K211854 · Vita Zahnfabrik GmbH H Rauter & CO · Nov 2021