(87 days)
Seals dentin tubulae in order to reduce post-operative sensitivity; will also improve the quality and functionality of restorations when used in conjunction with dental restoratives and cernents.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The text provided is a 510(k) clearance letter from the FDA for a device called "Sci-Pharm Desensitizing Varnish." This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It does not contain details about performance studies, acceptance criteria, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request for the detailed table and study information.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.