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510(k) Data Aggregation
(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, < 5% |
| (5) Ames mutagenicity test | (5) Mutagenicity Negative |
| (6) Oral mucous membrane irritation test | (6) No oral mucous irritation |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests (flexural strength, CTE, density, and biocompatibility tests). There is no information provided regarding the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the document describes performance testing of a material, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method
This information is not applicable as the document describes performance testing of a material, not a diagnostic device requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable as the document describes performance testing of a material, not a diagnostic device with human-in-the-loop performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the document describes performance testing of a material.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria appears to be based on established material science standards and biological safety assessments. For flexural strength, the benchmark is ISO 6872 requirements for anterior use (>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.
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