(175 days)
Dental Lithium Disilicate Glass Ceramic Blocks (Up. Press Series and Up. CAD Series) are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.
Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, P205, Al2O3, B2O3, and other oxides. It also contains inorganic pigments (Er2O3, V2O3, and MnO2) to provide different shades on the product surface. The performance of this lithium silicate dental blank conforms to ISO 6872. Dentistry: Ceramic Materials
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets these criteria:
This document is a 510(k) Premarket Notification from the FDA regarding a dental product, not an AI/ML device. Therefore, many of the requested categories related to AI performance, such as test sets, ground truth establishment, MRMC studies, and training sets, are not applicable.
However, I can extract the relevant information regarding the device's acceptance criteria and the studies that demonstrate compliance.
Device: Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and UP. CAD Series)
Acceptance Criteria and Reported Device Performance
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flexibility Strength (MPa) | Meet the requirements of ISO 6872:2008 | Meet the requirements of ISO 6872:2008 (Subject device has higher flexural strength compared to predicate) |
| Radioactivity (Bq•g-1) | (Implicitly, within acceptable limits of ISO 6872:2008) | (Not explicitly stated in table, but implied to meet standards) |
| Density (g/cm3) | (Implicitly, within acceptable limits of ISO 6872:2008) | (Not explicitly stated in table, but implied to meet standards) |
| Coefficient of Thermal Expansion (K-1) | (Implicitly, within acceptable limits of ISO 6872:2008) | (Not explicitly stated in table, but implied to meet standards) |
| Glass Transition Temperature (°C) | (Implicitly, within acceptable limits of ISO 6872:2008) | (Not explicitly stated in table, but implied to meet standards) |
| Cytotoxicity | No cytotoxicity effect (per ISO 10993-5:2009) | No cytotoxicity effect |
| Irritation Oral Mucosa Irritation | Not a primary oral mucosa irritant (per ISO 10993-10: 2010) | Not a primary oral mucosa irritant under the conditions of the study |
| Sensitization | Not a sensitizer (per ISO 10993-10: 2010) | Not a sensitizer under the conditions of the study |
| Subacute and Subchronic Toxicity | No subacute and subchronic toxic effects (per ISO 10993-11: 2006) | No subacute and subchronic toxic effects observed |
| Genotoxicity | No genotoxic effects (per ISO 10993-3: 2003) | No genotoxic effects observed |
Studies Demonstrating Compliance:
-
Bench Testing:
- Standard: ISO 6872:2008 (Dentistry: Ceramic Materials).
- Methodology: Performed according to the standard and internal procedures.
- Results: "All tests were verified to meet acceptance criteria."
- Goal: To ensure the Dental Lithium Disilicate Glass Ceramic Block met its specifications, particularly for mechanical properties like flexural strength. The subject device showed "higher flexural strength and potentially wider dental applications compared with predicate device."
-
Biocompatibility Testing:
- Standard: ISO 10993 series (FDA recognized consensus standard).
- Specific Tests and Standards:
- Cytotoxicity: ISO 10993-5:2009
- Irritation Oral Mucosa Irritation: ISO 10993-10: 2010
- Sensitization: ISO 10993-10: 2010
- Subacute and Subchronic Toxicity: ISO 10993-11: 2006
- Genotoxicity: ISO 10993-3: 2003
- Results: "Results met all relevant requirements in the test standards, and are comparable to the predicate device." This means the device demonstrated no cytotoxic, irritant, sensitizing, subacute/subchronic toxic, or genotoxic effects.
- Goal: To verify the equivalent safety of the materials used in the device.
Information not applicable to this device (as it's not an AI/ML device):
- Sample size used for the test set and the data provenance: Not applicable. Performance is based on material property testing, not a dataset of cases.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is based on standard material science measurements and biological assays, not expert interpretation of cases.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device involves established physical and chemical properties measured according to international standards (ISO). For biocompatibility, it's based on biological assay results aligning with ISO 10993 pass/fail criteria.
- The sample size for the training set: Not applicable.
- 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.