(73 days)
Suitable for cementation of crowns, bridges, inlays and orthodontic bands.
Also suitable for sealing interface between restoration and tooth and base / liner in deep restorations.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Southern Dental Industries, Incorporated for a device named "Riva Luting," a dental cement. This document is a regulatory approval letter and does not contain the acceptance criteria or a study describing the device's performance against such criteria.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means the approval is based on substantial equivalence to an already approved predicate device, not on a new study demonstrating performance against specific acceptance criteria. The document does not provide details about any studies or acceptance criteria beyond the general indications for use.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies from the provided text.
§ 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.