(60 days)
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:
| Performance Metric | Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|---|
| Flexural Strength | EN ISO 6872:2015 | Bench testing performed per standard |
| Linear Thermal Expansion | EN ISO 6872:2015 | Bench testing performed per standard |
| Chemical Solubility | EN ISO 6872:2015 | Bench testing performed per standard |
| Glass Transition Temperature | EN ISO 6872:2015 | Bench testing performed per standard |
| Radioactivity | EN ISO 6872:2015 | Bench testing performed per standard |
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.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.