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510(k) Data Aggregation
(42 days)
Light source for the purpose of curing light activated dental composites and activating dental bleaching agents.
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The provided text is an FDA 510(k) clearance letter for a device named PULSTAR™. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include the technical details of the device's validation or verification.
Therefore, I cannot provide the requested information based on the input text.
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(41 days)
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