(49 days)
for cementing temporary crowns, bridges, and other restorations as well as for trial cementing permanent restorations
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for a dental cement device. It does not contain any information about acceptance criteria, device performance, study details, or ground truth related to an AI/ML medical device. The letter confirms that the device, "NON-EUGENOL TEMPORARY CEMENT," is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (dental cement) and not a software-driven or AI-enabled 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.