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The PENG LIM High Speed Air Turbine Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Dental Air-Powered Handpiece

The provided text is a 510(k) summary for a dental handpiece, focusing on establishing substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it concludes equivalence based on comparison of "formulations and intended uses."

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states:

"The claim of substantial equivalence is based on comparisons of formulations and intended uses of the PENG LIM High Speed Air Turbine Handpiece, models: Super-AIR and Super-QD series and its claimed predicate."

This implies that detailed performance data, specific acceptance criteria, or a standalone study with human readers and ground truth, as typically required for demonstrating device performance against specific metrics, were not part of this 510(k) submission as presented. The FDA's letter also confirms that the determination is based on substantial equivalence to a legally marketed predicate device, not necessarily on a de novo performance study against defined acceptance criteria.

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This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

This LED Prolux 770 is a visible curing unit designed for polymerization of light cured materials used by dental professionals.

This query cannot be answered from the provided text. The document is a 510(k) summary for a dental curing light. It discusses the device's intended use and compares it to a predicate device, concluding that it is substantially equivalent. However, it does not provide details about specific acceptance criteria, performance studies with reported metrics, sample sizes, expert qualifications, or detailed ground truth methodologies that would typically be found in a clinical study report. The document primarily focuses on regulatory approval based on equivalence rather than detailed performance study results against specific criteria.

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