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510(k) Data Aggregation
(6 days)
The Clear Blue Digi LED curing light is a hand-held LED polymerization light intended to cure dental composites using visible light.
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The provided text is a 510(k) clearance letter from the FDA for a dental device, the "Clear Blue Digi LED Curing Light." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Therefore, I cannot provide the requested information based on the input text. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the specific testing methodologies or results.
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(7 days)
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