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LANG DENTAL TOOTH SHADE TEMPORARY CROWN AND BRIDGE ACRYLIC RESIN is intended for the fabrication of temporary crowns and bridges.

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This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria or study data for device performance. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of expert involvement for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• The type of ground truth used or details about training sets.

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Proviso™ is a self-cured material that is intended for the fabrication of temporary crowns and bridges.

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This document is a 510(k) clearance letter from the FDA for a dental device called Proviso™. It establishes substantial equivalence to a predicate device, which allows the new device to be marketed. However, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The 510(k) process primarily relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, it does not raise different questions of safety and effectiveness and is as safe and effective as the predicate device. This often involves comparing performance characteristics to the predicate, but the specific details of such comparative testing or acceptance criteria are typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the provided text. The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device we have determined the device is substantially equivalent...". This indicates the FDA reviewed data, but the data itself is not presented here.

To answer your questions, I would need to review the actual 510(k) submission document, which would detail the performance data, acceptance criteria, and specific studies conducted.

Ask a specific question about this device