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Color and Multilayer-SHT are intended for the manufacturing of partial and single crowns, full arch occlusally screwed bridges, inlays, onlays, and veneers, full contour restorations as well as reduced structures in combination with veneering ceramics. The products are categorized into class 5 according to ISO 6872.

Multilayer-3D is intended for the manufacturing of partial and single crowns, max. 3-unit bridges, inlays, onlays and veneers, full contour restorations as well as for reduced structures in combination with veneering ceramics and implant superstructures for 3-unit restorations in the anterior and posterior tooth region. The products are categorized into class 4 according to ISO 6872.

The products are suitable for all milling machines which are able to process presintered zirconia and which have the proper clamping device for the corresponding block.

Device Description

Dental Zirconia Pre-shaded Block is composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Mn2O3). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.

Dental Zirconia Pre-shaded Block has two color representations (i.e. monolayer and multilayer), corresponding to the categories of Color and Multilayer. The Multilayer also divided into two subcategories (Multilayer-SHT and Multilayer-3D) according to the consistency of the translucency across the zirconium block. And it offers various shapes and dimensions suitable for different milling systems.

The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.

The performance of the proposed device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.

AI/ML Overview

This document is a 510(k) summary for a medical device called "Dental Zirconia Pre-shaded Block". The 510(k) process is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This process does not involve the type of acceptance criteria and study design typically associated with AI/ML-driven diagnostic devices that assess patient conditions or make clinical recommendations.

Because this document is about a material used in dentistry (zirconia blocks for crowns and bridges), the "acceptance criteria" and "study" are related to material properties and biocompatibility as per relevant international standards (ISO), rather than diagnostic performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML devices.

Therefore, many of the requested elements for describing AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of medical device submission.

However, I can extract information related to the performance testing of the material, which serves as its "acceptance criteria" in the context of material science.

Acceptance Criteria and Device Performance for "Dental Zirconia Pre-shaded Block"

The acceptance criteria for this dental material are based on the international standard ISO 6872:2015 Dentistry - Ceramic materials. The study proving the device meets these criteria involved non-clinical performance testing and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

The requirements are defined by ISO 6872:2015. The device's performance is reported for two categories: "Multilayer-3D" and "Color, Multilayer-SHT".

Test Item	Acceptance Criteria (from ISO 6872:2015)	Reported Device Performance (Multilayer-3D)	Reported Device Performance (Color, Multilayer-SHT)	Judgment
Physical Properties
Uniformity	Uniform (as per standard)	Uniform	Uniform	Pass
Freedom from extraneous materials	Free from extraneous materials	Free from extraneous materials	Free from extraneous materials	Pass
Radioactivity	≤ 1.0 Bq·g⁻¹	0.019 Bq·g⁻¹	0.019 Bq·g⁻¹	Pass
Flexural strength	Multilayer-3D: ≥ 500 MPa	1172.2 MPa	1110.9 MPa	Pass
	Color, Multilayer-SHT: ≥ 800 MPa	(N/A for Multilayer-3D)	(N/A for Color, Multilayer-SHT)
Linear thermal expansion coefficient	(10.5 ± 0.5) × 10⁻⁶ K⁻¹ (as per standard)	10.8 × 10⁻⁶ K⁻¹	10.9 × 10⁻⁶ K⁻¹	Pass
Chemical solubility

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