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510(k) Data Aggregation
(85 days)
Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO)
Dental Lithium Disilicate Glass Ceramic is available using CAD/CAM and hot pressing techniques for the preparation of full ceramic crowns, inlays, onlays, veneer and full ceramic 3-unit anterior bridges.
Dental Lithium Disilicate Glass-Ceramic is a lithium disilicate ceramic to be supplied in the form of cuboid and cylinder. Dental Lithium Disilicate Glass-Ceramic can be fabricated using CAD/CAM and hot pressing technologies. The device is a glass type material used for aesthetic purposes of full ceramic crowns, inlays, onlays, veneer and full ceramic 3unit anterior bridges. The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3, ZrO2 and other oxides. It contains inorganic pigments. The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the device conforms to ISO 6872:2015 Dentistry: Ceramic Materials. It is a single-use device, and provided non-sterile.
The provided text describes a 510(k) premarket notification for a dental device, Dental Lithium Disilicate Glass Ceramic. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, the information typically associated with studies proving device performance, especially in the context of AI/ML or diagnostic devices, is not present here.
Based on the provided information, I can extract the acceptance criteria and details about the study (which is non-clinical bench testing) that demonstrates the device meets these criteria. However, many of the specific questions you asked (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study details, standalone performance, data provenance) are not applicable because this is a submission for a material, not a diagnostic or AI-driven device.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are established based on relevant ISO standards for dental ceramic materials and the performance of the predicate device.
| Performance Metric | Acceptance Criteria (Predicate Device K230487) | Reported Device Performance (Proposed Device K242740) |
|---|---|---|
| Types, Class (ISO 6872:2015) | Type II, Class 3 | Type II, Class 3 |
| Freedom from Extraneous materials | Free from extraneous materials | Free from extraneous materials |
| Flexural Strength | ≥300MPa | ≥300MPa |
| Linear thermal Expansion coefficient | $(9.8±0.5)×10^{-6}K^{-1}$ | $(9.8±0.5)×10^{-6}K^{-1}$ |
| Glass Transition Temperature | 495±20°C | 495±20°C |
| Chemical Solubility |
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