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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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SECURALLOY ™ is a dental amalgam for use in the obturation of the cavities of posterior teeth and building of false stumps.

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The provided document is a 510(k) clearance letter from the FDA for a dental amalgam device called SECURALLOY™. This document primarily concerns the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.

This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based solely on this document. The letter only confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent for its stated Indications For Use. The details about the studies conducted to demonstrate this equivalence would typically be found in the original 510(k) submission, not in the clearance letter itself.

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