(91 days)
TempoCem N/E is a dental luting agent for the temporary cementation of crowns and bridges.
Not Found
The document provided is a 510(k) premarket notification letter from the FDA for a dental luting agent called TempoCem N/E. It does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is not a medical imaging or AI-driven device.
Therefore, I cannot fulfill your request using the provided text. The document is about a dental cement and its regulatory approval process, not about a device that undergoes performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
§ 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.