(253 days)
HEMASEAL & CIDE is to be used to seal dentinal tubules in cavity preparations or sensitive root surfaces. It also aids in wetting for tubules to provide a better bond for resin fillings and cements.
Not Found
This document is a 510(k) premarket notification approval letter for a dental device called "HemaSeal & Cide." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria or details of a study demonstrating the device meets those criteria.
The letter is primarily a regulatory approval based on the comparison to existing devices, rather than a performance study report. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) from the provided text.
The "Indications For Use" section on page 2 simply states what the device is intended for, not how its performance was measured or what criteria it had to meet.
§ 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.