(89 days)
Luminesse Anterior Zirconia blanks/discs are indicated for use with CAD/CAM technology or manual milling machines to produce all-ceramic custom dental restorations - full contour crowns and bridges for anterior location - as prescribed by a dentist.
Luminesse Anterior Zirconia are used for full contour Zirconia dental restorations utilizing CAD/CAM system for design and manufactured. Once designed and manufactured, Luminesse Anterior Zirconia will undergo sintering. The anterior Zirconia products are pre-shaded to meet all 16 VITA® shading guide; hence, no further coloring is necessary post-sintering. Once sintered, Luminesse Anterior Zirconia will exhibit maximum strength anterior dental restorations.
The provided text describes the Luminesse Anterior Zirconia device, which is a material used for dental restorations. The document is a 510(k) summary submitted to the FDA, indicating that the device is seeking substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 6872) | Reported Device Performance (Luminesse Anterior Zirconia) |
|---|---|
| Flexural Strength: > 600 MPa (for anterior use) | 622 MPa (average) |
| Coefficient of Thermal Expansion: Not explicitly stated, but compared to predicate. | 10.5 x 10^-6/K |
| Density: Not explicitly stated, but compared to predicate. | >6.05 g/cm³ (sintered) |
| Biocompatibility: | |
| (1) Cytotoxic Tests (Agar diffusion test and filter diffusion test) | (1) 0 level |
| (2) Short-term systemic toxicity (oral route) | (2) No systemic toxicity |
| (3) Test for irritation and delayed-type hypersensitivity | (3) No hypersensitivity |
| (4) Hemolytic Test | (4) Hemolysis rate, 600 MPa). For biocompatibility, standard toxicology and irritation tests are used to demonstrate safety, with acceptance criteria like "0 level" for cytotoxicity and "no systemic toxicity." |
8. The Sample Size for the Training Set
This information is not applicable as this device is a material, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 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.