(71 days)
- As a structural reinforcement for fabricating and/or repairing Class III and Class V restorations
- Restoration of root surface caries
- Restorations of cervical erosions
- Small Class I restorations
- Primary teeth restoration
- Core build up
- Liner
Virto Fil LC is a dental cement that is composed of varoius 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. Vitro Fil LC is a resin modified glass ionomer base cement used as a temporary tooth filling. Vitro Fil LC offers a strong bonding of the ionomer to the tooth. The glass ionomer offers high chemical adhesion, fluoride release and biocompatibility. Vitro Fil LC is for permanent cementation.
This document, K123824, is a 510(k) premarket notification for a dental cement called "Vitro Fil LC." It does not contain information about a study with acceptance criteria and reported device performance in the context of evaluation using a test set, ground truth, or expert review, as would be expected for an AI/ML powered device.
Rather, this document is a regulatory approval for a medical device (dental cement) based on its substantial equivalence to previously marketed predicate devices. The safety and effectiveness are established by comparing its intended use, materials, form factor, performance, and safety characteristics to those of the predicate devices.
Therefore, I cannot provide the requested information as it is not present in the provided text. The sections requested (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are typically associated with the evaluation of AI/ML software or diagnostic devices, not with traditional material-based medical devices like dental cement undergoing a 510(k) substantial equivalence review.
§ 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.