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E-Temp is a light-curable resin indicated for the fabrication of individual and fixed temporary full single crowns, temporary partial crowns and temporary bridges in dental laboratories. The material is an alternative to traditional restorative dental material. E-Temp is intended exclusively for professional dental work. Fabrication of dental applications with E-Temp requires a computer aided and manufacturing (CAD/CAM) system that includes the following components: digital dental files based on a digital impression or in case of artificial teeth for dental prostheses the digital dental files based on manufacturer's data, a digital light processing (DLP) printer, and curing light equipment.

The E-Temp system combines a scanner with design software, the light-curable resin, a 3D printer and a curing unit. These components are used together during the manufacture of the customized temporary crowns or bridges. The light-curable resin is a proprietary composition of acrylates, methacrylates, methacrylated oligomers and monomers, photo initiators, colorants/dyes and absorbers. It is used by dental laboratories to make the customized temporary crowns and bridges for patients who need restoration of their natural teeth. E-Temp is available in six different colors. The resin is packaged in lightproof 1 kg PE bottles along with a programmed RFID chip (referred to as TAG), which is required for use with the validated 3D printers. The TAG contains information identifying the resin material, name and amount. E-Temp resin is an alternative material to heat-curable and auto-polymerizable resins. EnvisionTECs Perfactory® 3D-Printer DLP models designed and validated for use with the E-Temp light cured resin are: EnvisionOne cDLM, with LED, Micro series, with LED, Vida Series, with LED, P4K Series, with LED, D4K Series, with LED.

This document is a 510(k) premarket notification for the dental device E-Temp, a light-curable resin for temporary crowns and bridges. It does not contain information about an AI/ML powered device. Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, or comparative effectiveness studies for an AI device.

The document primarily focuses on the substantial equivalence of the E-Temp resin to a predicate device, based on material properties, biocompatibility, and manufacturing processes, which are standard for dental materials.

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