(54 days)
Nexus 2 is a dual cured, resin-based, dental cement designed to be used for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.
The device is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 is a two-part, base/catalyst - paste/paste, system.
The provided text is a 510(k) Summary and an FDA clearance letter for a dental cement called Nexus 2. This document does not describe any clinical study or acceptance criteria for device performance in the way typically required to assess risk and efficacy for more complex medical devices.
Instead, it focuses on demonstrating substantial equivalence to a predicate device (Kerr Corporation, Nexus Universal Luting Cement) based on similar intended use and functional characteristics. Dental cements like Nexus 2 are generally evaluated based on material properties (e.g., bond strength, solubility, film thickness) through bench testing, rather than extensive clinical trials with human subjects.
Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as this information is not present in the provided document.
The relevant information from the document is:
- Device Name: Nexus 2 (Luting Cement)
- Intended Use: Luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.
- Substantial Equivalence Claim: Nexus 2 is substantially equivalent to other legally marketed devices, specifically "Kerr Corporation, Nexus Universal Luting Cement," in its function and intended use.
- Device Description: Dual cured, chemical and light cured, two-part (base/catalyst - paste/paste) resin-based dental cement.
§ 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.