(90 days)
For luting temporary crowns to prepared crowns.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Healex Products, Incorporated, regarding their dental cement called "Preserve-Temp Plus." This document primarily addresses the substantial equivalence determination for a medical device and its intended use.
It does not contain information regarding acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or details about standalone or MRMC studies.
Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, number of experts, adjudication method, MRMC study details, standalone study details, type of ground truth, training set sample size, and ground truth for training set) based on the provided text. The document is an FDA approval letter, not a study report or technical specification document for the device's performance.
§ 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.