(126 days)
Nanova Sealant is indicated for use as a pit and fissure sealant
Not Found
This document is a 510(k) clearance letter for the Nanova™ Sealant, a pit and fissure sealant. It confirms that the device has been found substantially equivalent to a predicate device.
However, the provided text does NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document is a regulatory communication from the FDA, and while it confirms the device can be legally marketed, it does not detail the technical performance studies that would typically be included in a 510(k) submission to demonstrate substantial equivalence. Such performance data would be in the original 510(k) submission (K171330), not in the clearance letter itself.
Therefore, I cannot provide the requested information from the given text.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.