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CERANUM 82 is intended for manufacturing:

• Single Crown -
• Bridges -
• Implant superstructures

CERANUM 82 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 82 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

The provided text describes a 510(k) premarket notification for a dental casting alloy, Ceranum 82, and its substantial equivalence to a predicate device, Metalor's V-Supragold. This is a material comparison, not a medical device involving AI, image analysis, or clinical performance studies in the way the request implies. Therefore, many of the requested fields are not applicable.

Here's the relevant information extracted and presented:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the properties of the predicate device, Metalor's V-Supragold, and relevant industry standards (ANSI/ADA 5 and ISO 9693). The device (Ceranum 82) meets these criteria by demonstrating comparable physical and mechanical properties within acceptable ranges. The "acceptance" is based on showing substantial equivalence rather than meeting strict predefined thresholds for a new clinical outcome.

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