LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162408
    Device Name
    Nano Varnish, Plaquit, Lightpaint on Surface
    Manufacturer
    DREVE DENTAMID GMBH
    Date Cleared
    2018-04-05

    (584 days)

    Product Code
    EBD
    Regulation Number
    872.3310
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K123761
    Why did this record match?
    Device Name :

    Nano Varnish, Plaquit, Lightpaint on Surface

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

    Dental sealing lacquer for coating resin temporaries

    Device Description

    The light-curing one-component dental sealing lacquers NanoVarnish, Plaquit and Lightpaint on Surface are designed for coating resin parts of complete and partial dental prosthesis and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental sealing lacquer. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI-powered device performance. Therefore, many of the requested criteria regarding AI acceptance, human readers, and ground truth for AI model training cannot be extracted from this document.

    Here's what can be extracted based on the provided text:

    Acceptance Criteria and Device Performance

    For this type of device (a dental material), "acceptance criteria" are based on demonstrating comparable physical and chemical properties to a legally marketed predicate device, rather than accuracy metrics for an AI system. The study performed is a comparative study of the new device against a predicate device.

    Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Predicate: VITA ENAMIC® Glaze K123761)Reported Device Performance (NanoVarnish, Plaquit, Lightpaint on Surface)
    Intended UseSealing lacquer for characterization of dental restorationsDental sealing lacquer for coating resin temporaries
    Indications for UseFinal coating for shade customization/characterization, protection from abrasion wearVarnish for final coating for resin temporaries to produce a smooth and shiny surface
    DesignSupplied in glass bottlesSupplied in glass bottles
    Chemical DescriptionOne component UV-light curing (meth)acrylic lacquer radical polymerizationOne component UV-light curing (meth)acrylic lacquer radical polymerization
    Appearance (visual)Colorless, liquidColorless, liquid
    Viscosity at 23°C≤ 0.15≤ 0.15 - 0.02
    Pencil hardness (acc. to Wolff Wilborn)2 H2 H
    Working / Processing time
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1