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For use as a bonding primer with self curing resins to enhance the adhesion of resin to the metal components of removable dentures.

The product is a bonding primer designed for use with Tokuyama's Tokuso Rebase or other types of self-curing acrylic resins to enhance the bonding of resin to metal in dentures. It is not intended for OTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions.

This document is a 510(k) summary for Tokuso Rebase Mr. BOND, a dental bonding primer. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance

The provided document does not contain explicit acceptance criteria or detailed reported device performance in a quantitative manner as would typically be found in a study for a medical device. The submission focuses on the chemical composition and intended use of the bonding primer, rather than a performance-based clinical or laboratory study with specific endpoints and thresholds.

The crucial statement related to performance is: "It was approved in November 1990 for marketing in Japan by the Ministry of Health and Welfare." This implies that the Japanese regulatory body found the device's performance acceptable based on their criteria at that time. However, the specific criteria or the data supporting that approval are not detailed in this 510(k) summary.

2. Sample size used for the test set and the data provenance

No test set sample size or data provenance (e.g., country of origin, retrospective/prospective) is mentioned in the provided 510(k) summary. The submission relies on the prior approval in Japan and the statement that it "contains materials that are common in dental use and pose no health hazard when used according to directions."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.

4. Adjudication method for the test set

Not applicable. There is no mention of a test set or an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. The document does not describe a multi-reader multi-case comparative effectiveness study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a dental bonding primer, not software or an algorithm.

7. The type of ground truth used

Not applicable. The document does not describe a study with explicit ground truth determination. The basis for approval appears to be the material composition and prior regulatory clearance in Japan.

8. The sample size for the training set

Not applicable. The document does not describe a "training set" in the context of an algorithm or AI model development.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set or how ground truth for it might have been established.

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