(2 days)
Titanium Porcelain is used for the veneering of artificial teeth for fixed prothesis in titanium crowns, bridges and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to the titanium coping into the shape of a dental crown.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Vita Titanium Porcelain." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of imaging or AI devices, which is what your query seems tailored for.
The letter is a regulatory approval document confirming substantial equivalence to a predicate device and outlines general regulatory information for the device's manufacturer. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about a test set, data provenance, or sample sizes.
- Information on experts for ground truth establishment or adjudication methods.
- Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Information about standalone algorithm performance.
- The type of ground truth used for a study.
- Training set sample sizes or how training ground truth was established.
Therefore, I cannot fulfill your request with the input provided.
§ 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.