(49 days)
Fuji I is a self-cure glass ionomer material intended for the use as a luting cement for cementation of inlays, crowns, bridges and orthodontic bands.
Fuji I is a self-cure glass ionomer material.
The provided document is a 510(k) clearance letter from the FDA for a medical device called "Fuji I," issued in 1998. This type of document declares substantial equivalence to a predicate device and permits marketing. It outlines the intended use of the device.
However, the document does not contain the detailed information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or clinical study methodologies. The FDA 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical performance studies with detailed statistical analysis as might be found for novel, high-risk devices or software as a medical device (SaMD) clearances today.
Therefore, I cannot populate the requested information from the provided text. The document is too old and not detailed enough to address these modern requirements for a device performance study.
§ 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.