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Missing tooth structure in anterior and posterior teeth

Types of restorations:

• Veneers

• Inlays

• Onlays (e.g. occlusal veneers, partial crowns)

• Crowns

IPS e.max® One is a glass-ceramic block for the fabrication of fixed, full-contour single-tooth restorations in anterior and posterior teeth. IPS e.max One can be processed in milling machines and polished afterwards. A crystallization process is not necessary. The dentist starts with shade selection, preparation of the tooth based on guidelines for all-ceramic restorations, follow the recommended griding instruments and minimum layer thickness during finalizing and finishing, and finish with dental polishing.

Types of restorations: -Veneers -Inlays -Onlays (e.g. occlusal veneers, partial crowns) -Crowns

This document describes the premarket notification for the IPS e.max® One dental material. As such, it does not contain details of an AI/ML powered medical device. Therefore, the requested information on acceptance criteria, reader studies, and ground truth for an AI/ML device is not applicable and cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of the IPS e.max® One to a predicate device, IPS e.max CAD (K051705), based on non-clinical performance testing and biocompatibility.

Here's the relevant information about the non-clinical performance testing:

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document states "Bench testing was performed... according to EN ISO 6872:2015" for these properties. It does not provide specific numerical results of the performance.

2. Sample size used for the test set and the data provenance: Not applicable. This is a material test, not a test on a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for material properties is defined by the standards and physical testing methodologies.

8. The sample size for the training set: Not applicable. This is material testing, not an AI model.

9. How the ground truth for the training set was established: Not applicable.

Biocompatibility:

The biocompatibility evaluation was performed according to ISO 10993-1:2009, ISO 7405:2018, and ISO 14971:2019. The evaluation concluded:

• Not cytotoxic
• No sensitizing potential for lithium disilicate glass-ceramic blocks (LS2)
• Does not induce oral mucosal irritation
• No potential for material-mediated pyrogenicity
• No risks for acute, sub-acute, sub-chronic toxicity
• Not genotoxic
• Negligible risk of carcinogenicity
• No direct contact to pulp or dentin.

Conclusion of the study:

The study concludes that IPS e.max® One is substantially equivalent to the predicate device IPS e.max CAD based on the non-clinical performance testing and biocompatibility assessment, despite differences in chemical composition and the elimination of a crystallization step for the new device. The new device covers similar indications (veneers, inlays, onlays, and crowns) but lacks the indication for bridges that the predicate device has.

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