(84 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
NUPRO® T PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN® is a unique blend of polishing and cleaning agents designed for professional application during standard dental practice hygiene procedures. The new device contains fluoride, triclosan®, an abrasive, a sweetener, water, flavoring, color, thickeners, and preservatives.
The provided text is a 510(k) summary for a dental prophylaxis paste. It details the device's description, intended use, and technological characteristics, and references predicate devices. However, the document does not contain the specific information requested about acceptance criteria, device performance from a study, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document primarily focuses on establishing substantial equivalence to a predicate device, relying on the safety of its components and prior use in other dental products.
§ 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.