(196 days)
Butler GUM Prophylaxis Paste with NovaMin® is intended for cleaning and polishing procedures as a part of a professionally administered dental prophylaxis treatment. Secondarily, Butler GUM® Prophylaxis Paste with NovaMin® can be used for the immediate relief of tooth sensitivity, post-scaling and root planing.
Bulter GUM® Prophylaxsis Paste with NovaMin® is intended for use in a professionally administered cleaning and polishing procedure during the prophylaxis treatment. The NovaMin® in the paste reduces sensitivity by occluding dentinal tubules.
I am sorry, but based on the provided document, there is no information available regarding the acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) summary for a prophylaxis paste, primarily discussing its substantial equivalence to a predicate device and its intended use. It does not contain the details you've requested about device performance, study designs, expert involvement, or ground truth establishment.
§ 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.