(525 days)
For use by a dental professional for the purpose of cleaning teeth.
RE NU Prophy Paste
The provided document is a 510(k) clearance letter from the FDA for a device named "RE NU Prophy Paste". This type of letter indicates that the device is substantially equivalent to a legally marketed predicate device and can be marketed.
However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. Such detailed technical study results are typically found in the 510(k) submission itself, which is not fully included here, or in associated scientific publications.
The document only states the "Indications For Use" for the device: "For use by a dental professional for the purpose of cleaning teeth." This indicates the intended purpose of the device, but not its performance metrics or how those metrics were tested.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided text.
§ 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.