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510(k) Data Aggregation
(89 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Not Found
This is a tough one! I cannot find the acceptance criteria or study details within the provided text. The document is primarily an FDA clearance letter for a dental prophy paste, confirming its substantial equivalence to other legally marketed devices. It doesn't contain any information about performance studies, acceptance criteria, or specific metrics.
Therefore, I cannot generate the table or answer the questions you've posed. To provide that information, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) submitted to the FDA, a clinical study report, or even the 510(k) submission itself which would contain the study details.
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