(144 days)
This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.
This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.
The provided text describes a 510(k) premarket notification for a "Dental Porcelain Powder" device and outlines its acceptance criteria and non-clinical testing results. It does not describe an AI/ML powered medical device, an imaging device, or a study involving human readers. Therefore, many of the requested categories are not applicable to this document.
However, I can extract and present the information that is relevant to the acceptance criteria and non-clinical testing of this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| ID# | Test | Method | Acceptance Criteria | Reported Device Performance | Conclusion |
|---|---|---|---|---|---|
| 1.1 | Chemical composition of powder | Ingredient content analysis | Silicon dioxide (SiO2): 57-67% | ||
| Aluminum oxide (Al2O3): 10-20% | |||||
| Potassium oxide (K2O): 5-15% | |||||
| Sodium oxide (Na2O): 3-10% | |||||
| Boron trioxide (B2O3): 3-6% | |||||
| Calcium oxide (CaO): 20 MPa. | Met Product Technical Requirements | Pass | |||
| 1.12 | Blending liquid appearance | Visual inspection | There should be no visible foreign body. | Met Product Technical Requirements | Pass |
| 1.13 | Blending liquid specification | Volume measurement | It should be ±1 mL. | Met Product Technical Requirements | Pass |
| 2.1 | Cytotoxicity | ISO 10993-5:2009 | Non-cytotoxic | Non-cytotoxic | Pass |
| 2.2 | Delayed hypersensitivity | ISO 10993-10:2010 | Non-Delayed hypersensitivity | Non-Delayed hypersensitivity | Pass |
| 2.3 | Intradermal reaction | ISO 10993-10:2010 | Non-Intradermal reaction | Non-Intradermal reaction | Pass |
| 2.4 | Acute systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Non-Acute systemic toxicity | Pass |
| 2.5 | Subchronic systemic toxicity | ISO 10993-11:2017 | Non-Acute systemic toxicity | Non-Acute systemic toxicity | Pass |
| 2.6 | Genotoxicity | ISO 10993-3:2014 | Non-genotoxicity | Non-genotoxicity | Pass |
Since this is not an AI/ML-powered or imaging device, the following categories are not applicable to the provided document. The device is a "Dental Porcelain Powder" and the testing described is non-clinical bench testing and biocompatibility testing.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical, bench testing. The document does not specify sample sizes for individual tests but rather the acceptance criteria for material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized testing methods, not expert consensus in this context.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. No AI component.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for the non-clinical tests is based on the specified physical, chemical, and biological properties as defined by relevant ISO standards and product technical requirements.
- The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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.