(126 days)
The dental ceramic ceramics2in1 is a low fusing dental ceramic sinter material for the production of crowns and bridges made of zirconium oxide or titanium based coping and frameworks.
The system comprises ceramic materials typical for dental ceramics: shoulder margin, opaque, opaque dentin, dentin, incisal, effect, opal, gingiva, addon correction material, stains, shades, glaze and liquids
- Veneering of titanium copings / frameworks -
- -Veneering of zirconium oxide based copings / frameworks
The ceramics2in1 is a porcelain powder system for bonding to titanium or zirconium dental frameworks or copings. The device is used in prosthetic dentistry by heating in an oven to produce a hard prosthesis with a glass-like finish.
The system comprises ceramic materials typical for dental ceramics: shoulder margin, opaque, opaque dentin, dentin, incisal, effect, opal, gingiva, addon correction material, stains, shades, glaze and liquids
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 6872 (Solubility) | Within the limits of the standard; not significantly different to predicate device. |
| ISO 6872 (Bond Strength) | Within the limits of the standard; not significantly different to predicate device. |
| ISO 6872 (Flexural Strength) | Within the limits of the standard; not significantly different to predicate device. |
| Biocompatibility | No unacceptable toxic or allergic potential; Considered highly biocompatible; No unacceptable health risks. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are primarily focused on material properties rather than clinical performance trials with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable/not provided in the context of the material property tests described. The ground truth for these tests would be the measurement results against established ISO standards, not expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, which are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. The submission focuses on material equivalence to a predicate device, not on comparing human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/not provided. The device is a dental ceramic material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth used for the reported performance metrics (solubility, bond strength, flexural strength) was based on established international standards (ISO 6872). For biocompatibility, it was based on an evaluation against current knowledge regarding health risks.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a material, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as #8.
§ 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.