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IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. The system comprises three parts: IPS e.max CAD mesostructure, Ti base and CAD/CAM software. The IPS e.max CAD mesostructure cemented to the Ti base is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. The compatible Implant systems, Ti bases and CAD/CAM systems are shown below: Implant systems: Nobel Biocare Replace (K020646), Nobel Biocare Activem (K071370), Straumann Bone Level (K053088, K062129, K060958), Biomet 3i Osseotite (K980549) CAD/CAM Systems: Sirona inLab and Cerec SW 4.2 and above. For the titanium base Straumann Bone Level 3.3 L the indication is restricted for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

IPS e.max CAD Abutment Solutions is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. Titanium bases are a premanufactured prosthetic component directly connected to dedicated endosseous dental implants. The Titanium base is used for adhesion to mesostructures to restore function and esthetics in the oral cavity. IPS e.max CAD Abutment Solutions are lithium disilicate blocks in various sizes. One side of the block is mounted to a mandrel that will be inserted into the spindle's clamping chuck of the grinding machine. The connection geometry to titanium bases is prefabricated, i.e. already include in the shipped block. Connection geometries fit select Titanium Bases marketed by Straumann, Nobel Biocare and Biomet 31 as identified in the Intended Use section. The mesostructure is individually designed and milled using CAD/CAM Technology into the shape of a hybrid abutment or hybrid abutment crown as designed by the trained professional using the Sirona inLab and Cerec SW 4.2 (or higher) software.. The device serves as the esthetic mesostructure which is extraorally cemented onto a Titanium Base. The two piece abutment is mounted onto the implant and fixed with a screw.

This document describes the IPS e.max® CAD Abutment Solutions, a dental device consisting of a lithium disilicate ceramic mesostructure cemented to a titanium base, designed for single cement-retained restorations in conjunction with endosseous dental implants.

1. Acceptance Criteria and Reported Device Performance:

The device's performance is assessed against physical properties outlined in ISO 6872:2008 for Dental Ceramics. The acceptance criteria and reported values are provided in the table below:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes used for each physical property test. It refers to general "fatigue testing" performed for angled abutments according to FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments" (May 12, 2004). The data provenance is not specified beyond being generated as part of a 510(k) submission to the FDA. The tests would likely be prospective studies conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The "ground truth" for this device is not established by expert consensus on clinical images or diagnoses. Instead, "ground truth" refers to the established physical properties specified by international standards (ISO 6872:2008) for dental ceramics. The qualification of individuals conducting these standardized laboratory tests would typically be in materials science, engineering, or a related field, but specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., medical imaging reviews), not for physical property testing of materials against specified standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned or conducted. This type of study is not relevant for evaluating the physical properties of a dental materials device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

This information is not applicable. The device is a material and design system for dental restorations; it is not an algorithm or AI system. Its performance relates to its physical and mechanical properties, not an algorithmic output.

7. Type of Ground Truth Used:

The ground truth used for evaluating this device's performance is based on established international standards for physical properties of dental ceramics (ISO 6872:2008). This is a form of objective, quantitative measurement against pre-defined benchmarks, rather than subjective expert consensus, pathology, or outcomes data in a clinical setting for this specific aspect of the submission.

8. Sample Size for the Training Set:

This information is not applicable. The IPS e.max® CAD Abutment Solutions is a physical dental device/material, not an AI or machine learning model that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable, as there is no "training set" for this device.

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