(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.
§ 872.6030 Oral cavity abrasive polishing agent.
(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.