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Auropal Solder M-1 is intended for use as a primary solder in operations in which dental alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions.

Auropal Solder M-1 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a pale yellow alloy with high contents of precious metals (Gold, Palladium and Silver: 82%). Auropal Solder M-1 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as a primary solder for dental alloys with appropriate melting ranges and compositions, especially ECO E4, which is manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. In cases where secondary soldering is needed, Auropal Solder W-2 should be used. Auropal Solder M-1 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

This document is a 510(k) premarket notification for a dental brazing alloy, Auropal Solder M-1. It is not a study validating an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI device cannot be extracted from this document, as it pertains to a different type of medical device (a material, not a diagnostic or AI-driven tool).

The document is a regulatory submission for a traditional medical device (dental solder) and focuses on demonstrating substantial equivalence to a legally marketed predicate device based on its physical and chemical properties and intended use. Performance is typically evaluated against established material standards (like ISO 9333 for corrosion resistance mentioned in the text), not through AI-specific metrics.

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