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NobelRondo Dental Ceramic Alumina is a ceramic material intended for veneering substructures such as single crowns, multiple frameworks or abutments made from alumina.

NobelRondo Dental Ceramic – Alumina is dental porcelain intended for use in the construction of aluminum oxide ceramic prosthetics. NobelRondo consists of sixteen (16) porcelain shades corresponding to Vita shades A0-C3 and various shade modifiers. The shade modifiers are intended to give the user flexibility in creating a translucent or opalescent natural looking prosthetic. NobelRondo also includes mixing liquids and shade guides.

The various porcelains and modifiers are used in a build-up process. After applying each layer, the restoration is fired following directions in the Instructions for Use. All of the component porcelains and modifiers can be used in combination without restriction. The dental technician will use the components as needed to create the desired prosthetic. However, typical use includes using a base liner followed by a build-up material and finally glazes and stains. Throughout this process, modifiers for translucent and opalescent effects can be added.

The NobelRondo Dental Ceramic – Alumina is sold in kit form. The various porcelains and modifiers are packaged in polyethylene bottles with screw caps. Replacement bottles for each porcelain or modifier are available individually.

This document is a 510(k) Summary of Safety and Effectiveness for the NobelRondo Dental Ceramic – Alumina, a dental porcelain. It does not present any data relating to artificial intelligence (AI) or machine learning (ML) device performance.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a device that uses AI.

The document discusses the physical properties and intended use of a dental ceramic material and its substantial equivalence to a legally marketed predicate device (Procera® All-Ceramic Dental Porcelain). The FDA's review in this case is focused on the material's safety and effectiveness for its stated dental applications, not on the performance of a diagnostic or assistive AI system.

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