(71 days)
For cementation of Temporary Restorations
Not Found
This is a 510(k) clearance letter for a medical device (Temporary Cement). The provided document does not contain information regarding acceptance criteria, device performance studies, or details about training and test sets of AI algorithms.
The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It refers to general controls and FDA regulations but does not include any performance data or study design.
Therefore, I cannot extract the information required to answer your questions based on the provided text. This document is a regulatory approval, not a scientific study report.
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.