(52 days)
Nexus 3 is a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of amalgam restorations, and as core-buildup material.
Nexus 3 is a resin cement system comprising of a single-syringe light-cure veneer cement and a dual-syringe dual-cure all-purpose resin cement.
The provided document is a 510(k) premarket notification for a dental cement product called "Nexus 3". It describes the device, its intended use, and claims substantial equivalence to a predicate device ("Nexus 2").
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt regarding artificial intelligence (AI) device performance evaluation.
The document 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..." This indicates that the approval was based on substantial equivalence to an existing device, not on a new performance study that would typically involve acceptance criteria and detailed study results as described in your prompt.
Therefore, I cannot provide the requested information from this document. The information you are asking for is typically found in performance study reports for AI/ML-enabled devices, which this document is not.
§ 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.