(73 days)
TempFil is a light-cured, single component temporary filling material intended to be used for filling of inlay and onlay preparations, implant screw and endodontic access openings, and for the emergency replacement of lost fillings.
TempFil is a light cured single component temporary filling material designed for fabrication of provisional inlays and onlays. TempFil contains a resin base, which provides a sculptable viscosity with non-sticky placement. Available in syringe and unidose delivery systems; TempFil sets to a permanent elastic phase which allows for easy removal even in the presence of preparation undercuts.
This document is a 510(k) premarket notification for a dental material, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable and cannot be extracted from this document.
The document describes the device, TempFil, as a light-cured single component temporary filling material for provisional inlays and onlays, implant screw and endodontic access openings, and emergency replacement of lost fillings. It claims substantial equivalence to another legally marketed device, TempFil F-2.
The FDA's review and determination of substantial equivalence are based on the comparison of the device's characteristics (e.g., composition, intended use, performance) to a predicate device, rather than a clinical study with detailed performance metrics as would be expected for an AI/ML diagnostic or prognostic tool.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.