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Dental casting alloy for making restoration.

High gold casting alloy

This document describes the AURECAST 83 Dental casting alloy and its substantial equivalence to a legally marketed predicate device, Jelenko Benchmark I. The acceptance criteria and the study that proves the device meets them are based on comparisons of composition and physical/mechanical properties, not on a clinical effectiveness study with human readers or outcomes data.

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1. Table of Acceptance Criteria and Reported Device Performance

For this device, "acceptance criteria" are implicitly defined by the parameters deemed important for substantial equivalence to the predicate device. The "reported device performance" is the measured performance of AURECAST 83.

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