(14 days)
GI DentStat serves as a fluoride releasing temporary tooth filling or as a base cement to be applied i a tooth to protect the tooth pulp.
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The provided text is a 510(k) clearance letter from the FDA for a dental cement called "GI DentStat." It does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications related to an AI/ML medical device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this document is not relevant to such a request for an AI/ML device.
§ 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.