(15 days)
To be used for cleaning and polishing procedures as part of professionally administered prophylaxis treatment. To relieve dental hypersensitivity and for the management of tooth sensitivity following in-office bleaching procedures, ultrasonic, hand scaling or root planning.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental product. It primarily focuses on regulatory approval and substantial equivalence to a predicate device.
The document does not contain any information about clinical studies, acceptance criteria, device performance metrics, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot generate the requested table and answer the study-related questions based on this input.
§ 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.