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BegoPal+ is a porcelain-fused-to-metal (PFM) noble alloy. It is suitable for fabrication of crown and bridge restorations. BegoPal+ is available as powder and is processed by selective laser melting.

BegoPal+ is a palladium containing cobalt-chromium alloy for fabrication of porcelain fused to metal dental restorations. BegoPal+ is available as powder and is processed by selective laser melting.

This appears to be a 510(k) premarket notification document for a dental alloy, BegoPal+. This document does not contain information about software, or a device that would require the kind of performance study details (acceptance criteria, training/test sets, expert adjudication, MRMC studies) you've requested.

The document discusses:

• Device Description: BegoPal+ is a palladium-containing cobalt-chromium alloy for dental restorations.
• Processing: It's processed by selective laser melting (SLM).
• Indications for Use: Porcelain-fused-to-metal (PFM) noble alloy for crown and bridge restorations.
• Predicate Devices: Lists similar alloys (Wirobond C, Wirobond C+, Callisto CP+).
• Comparison to Predicate Devices: States substantial equivalence based on indications, technical parameters, and biocompatibility, despite differences in product shape, processing, and material composition.
• Testing: Mentions test results according to ISO 22674, ISO 9693-1, ISO 10271, and ISO 10993 which demonstrate safety and effectiveness.

Therefore, it is impossible to extract the information you requested from this document as it pertains to a physical material, not a software or AI-driven medical device.

If you are looking for an example of a 510(k) submission for a software or AI device, you would need a different document.

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