(86 days)
Desensitizing dentin surfaces by occluding dentin tubules with A mixture of 2 Liquids. Use under crowns And Gridges before cementation, OR for treating cervical Class V erosiono.
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This document is a 510(k) clearance letter from the FDA for a dental desensitizer called "D/Sense® II (Green-Or)". It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
Therefore, I cannot provide the requested information, particularly the table of acceptance criteria and reported device performance, or details about sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance. This document is a regulatory approval, not a scientific study report.
§ 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.