(56 days)
Indirect cementation of ceramic, composite and metal inlays, onlays, crowns, bridges, posts, screws and veneers.
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I am sorry, but the provided text is a 510(k) clearance letter for a dental cement (trade name "seT"). It does not contain any information about acceptance criteria or a study that proves the device meets those criteria for an AI or medical device that would have such a study.
The document is a regulatory approval notice, confirming that the dental cement "seT" is substantially equivalent to a legally marketed predicate device. This type of clearance does not typically involve the detailed performance studies or AI-specific evaluation metrics you've requested.
Therefore, I cannot extract the information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment from this document.
§ 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.