(93 days)
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations.
AURAVeneer Cement is a self-adhesive cement recommended for the bonding of ceramic and composite restorations. This veneer cement is made from a complimentary hydrophilic resin and filler system, which creates compatibility between the tooth surface and restorative materials. AURAVeneer Cement is a unique gel-like product that does not slump and will hold veneers in place without drifting. AURAVeneer is a single component, light cured product. AURAVeneer is provided in clear, enamel/white, and dentin/yellow shades. Corresponding try-in gels of the same colors are also available. It is recommended that enamel surfaces, which are uncut, be etched or micro-abraded to optimize bonding of this product to the dental surface. Etching or the use of bonding agents when bonding to dentin is not required. Equally, the surface of the restoration should also be pretreated to optimize bonding of the restoration. Bonding agents and silage coupling agents are not required for the use of this product.
The provided text is a 510(k) Premarket Notification for AURAVeneer Cement, a dental cement. It does not contain any information about a study with acceptance criteria, sample sizes, expert involvement, or any performance metrics typically associated with AI/ML device evaluations.
The document primarily focuses on establishing "substantial equivalence" of AURAVeneer Cement to existing predicate devices based on design, composition, and intended use, rather than presenting a performance study against specific acceptance criteria. This type of regulatory submission (510(k)) for a dental cement typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of physical and chemical properties, and intended use, rather than through extensive clinical trials with performance metrics.
Therefore, I cannot fulfill your request as the necessary information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in 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.