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The intended use for SECURALLOY dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 70 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.
The intended use for SEPTALLOY NG 50 dental amalgam is the filling cavities in posterior teeth (class I and class II restorations) and core build-up.

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This document is a 510(k) premarket notification decision letter from the FDA for dental amalgam devices. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot extract the requested information from the provided text.

The document states that the devices (Securalloy, Septalloy NG 50, and Septalloy NG 70) are "substantially equivalent" to legally marketed predicate devices, which is the basis for their clearance. It does not describe performance acceptance criteria or a study with specific metrics, sample sizes, or ground truth methodologies as would be expected for a detailed performance evaluation.

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