(584 days)
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.
Dental sealing lacquer for coating resin temporaries
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.
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
| Parameter | Acceptance Criteria (Predicate: VITA ENAMIC® Glaze K123761) | Reported Device Performance (NanoVarnish, Plaquit, Lightpaint on Surface) |
|---|---|---|
| Intended Use | Sealing lacquer for characterization of dental restorations | Dental sealing lacquer for coating resin temporaries |
| Indications for Use | Final coating for shade customization/characterization, protection from abrasion wear | Varnish for final coating for resin temporaries to produce a smooth and shiny surface |
| Design | Supplied in glass bottles | Supplied in glass bottles |
| Chemical Description | One component UV-light curing (meth)acrylic lacquer radical polymerization | One component UV-light curing (meth)acrylic lacquer radical polymerization |
| Appearance (visual) | Colorless, liquid | Colorless, liquid |
| Viscosity at 23°C | ≤ 0.15 | ≤ 0.15 - 0.02 |
| Pencil hardness (acc. to Wolff Wilborn) | 2 H | 2 H |
| Working / Processing time |
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.