(197 days)
MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment.
MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges.
The MAZIC Claro Press, dental glass ceramic ingot, is to make dental restorative prosthesis such as inlays, onlays, veneers, crowns and bridges. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through regular press process.
The MAZIC Claro CAD, dental glass ceramic block, is to make dental restorative prosthesis such as inlays, onlays, veneers and crowns. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.
This document describes the acceptance criteria and the study proving the device meets those criteria for the MAZIC Claro CAD and MAZIC Claro Press dental materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for both MAZIC Claro CAD and MAZIC Claro Press are based on conformance to ISO 6872: Dental ceramic. The reported device performance indicates that both devices conform to this standard for the specified physical and chemical properties.
| Acceptance Criterion (Standard) | MAZIC Claro Press Performance | MAZIC Claro CAD Performance |
|---|---|---|
| Uniformity (ISO 6872) | Conforms | Conforms |
| Freedom from extraneous materials (ISO 6872) | Conforms | Conforms |
| Flexural strength (ISO 6872) | Conforms | Conforms |
| Chemical solubility (ISO 6872) | Conforms | Conforms |
| Radioactivity (ISO 6872) | Conforms | Conforms |
| Linear thermal expansion coefficient (ISO 6872) | Conforms | Conforms |
| Glass transition temperature (ISO 6872) | Conforms | Not explicitly listed for CAD, but general conformance implied |
| Biocompatibility (ISO 10993-5, -10, -11, -3) | Confirmed (see tests below) | Confirmed (see tests below) |
2. Sample Size and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical performance tests or the data provenance (country of origin, retrospective/prospective). The tests were conducted according to ISO standards, implying controlled laboratory conditions.
3. Number and Qualifications of Experts for Ground Truth
Not applicable. This submission is for dental materials, and the "ground truth" is established through standardized physical, chemical, and biocompatibility testing, not through expert radiological or clinical interpretation of images.
4. Adjudication Method
Not applicable, as this is for material testing, not diagnostic performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device that involves human readers.
6. Standalone (Algorithm Only) Performance
Not applicable. This is for dental materials, not an algorithm. The performance is based on the material's inherent physical and chemical properties.
7. Type of Ground Truth Used
The ground truth used for these devices is established by international standards for dental ceramics and biocompatibility:
- ISO 6872 (Dental ceramic) for physical and chemical properties.
- ISO 10993 (Biological evaluation of medical devices) for biocompatibility.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of material performance testing for these dental ceramics. The material itself is the subject of the performance tests.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for these dental materials. The "ground truth" for evaluating the device's performance is the adherence to the established parameters and limits defined in the ISO 6872 and ISO 10993 standards. The performance tests are designed to measure these parameters directly.
§ 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.