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Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.

Denzir™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials.Denzir™ inlays are alternatives to gold, amalgam, porcelain, or composite filling materials, except that their application more closely resembles gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.

This document is a 510(k) summary for Denzir™, a dental restorative material, and does not contain the specific details about acceptance criteria and a study proving device performance as typically expected for software or AI-driven medical devices. The information provided focuses on demonstrating substantial equivalence to predicate devices, biocompatibility, and meeting general material standards.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

However, I can extract the relevant information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Information on a standalone (i.e., algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any specific performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

General Observations from the Text:

• The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, a common pathway for medical device clearance. This usually involves showing similar intended use, technological characteristics, and safety/effectiveness profiles.
• The material is certified for biocompatibility and meets ISO standards, which indicates it has undergone testing appropriate for a dental material.
• The device is a physical dental material (zirconium dioxide-yttrium oxide ceramic) for inlays, onlays, veneers, crowns, and bridges, not a software or AI-driven diagnostic/treatment planning device. Therefore, the types of studies and acceptance criteria typically associated with AI devices (e.g., sensitivity, specificity, MRMC studies) are not applicable or expected in this submission.

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