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Intended for use in preparation of crowns, facings, inlays and onlays-to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry. 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.

Sagemax Z-Blank™ 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 prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Sagemax Z-Blank "" prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opague, for ready visualization.

The provided K062695 document for Sagemax Z-Blank™ is a 510(k) Premarket Notification for a dental restorative material. The purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device (or devices). This is not a study that proves a device meets acceptance criteria in the way a clinical trial or performance study would for, for instance, an AI/ML medical device.

Key takeaway for your request: This document focuses on demonstrating substantial equivalence to existing predicate devices based on intended use, technological characteristics, and descriptive information about the material. It does not contain the type of performance study data, acceptance criteria tables, sample sizes, or expert ground truth information that would be found in a submission for a novel device or an AI/ML-driven device.

Therefore, I cannot extract the specific information you requested in points 1-9 for this document because it is not present. The document explicitly states:

• "The successful prior use of the components of Sagemax Z-Blank™ product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of Sagemax Z-Blank to prior cleared devices support the safety and effectiveness of the Sagemax Z-Blank™ product for the intended use."
• "These products have the same intended use..."
• "The technological characteristics for this product are similar to those for the 2. The technological ohose currently on the market except for slight differences in predicate donood and the technological differences are well understood in the mothous of too."

This indicates that the submission relies on the established safety and effectiveness of predicate devices and the material's well-known properties, rather than new performance studies with specific acceptance criteria that would require test sets, ground truth, and expert adjudication.

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