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Glass Ionomer cement is used in a luting application and referred to as a cement for the attachment of indirect restorations and appliances to the teeth. The glass ionomer cements also bond adhesively to tooth structure and they inhibit infiltration of oral fluids at the cement-tooth interface.

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I apologize, but the provided text from the FDA 510(k) notification for Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer does not contain any information regarding acceptance criteria or a study proving the device meets said criteria.

The document is a letter from the FDA stating that the device is substantially equivalent to a predicate device and can therefore be marketed. It outlines regulatory requirements and contact information for further inquiries.

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and reported device performance
• Sample size used for the test set or data provenance
• Number of experts used to establish ground truth or their qualifications
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

To provide this information, you would need to supply a different document, such as a summary of safety and effectiveness, a clinical study report, or a pre-market approval application summary, which typically contains details about performance testing and acceptance criteria.

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