(1394 days)
Treatment of Dental Hypersensitivity.
Not Found
I apologize, but the provided text from the FDA 510(k) premarket notification letter for "Silver Dental Arrest" does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies for artificial intelligence or a medical device utilizing AI.
The document is a regulatory approval letter and an "Indications for Use" statement. It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It does not include the detailed technical study data that would be necessary to answer your questions regarding acceptance criteria and device performance.
Therefore, I cannot extract the requested information from the provided text.
§ 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.