Search Results

FREEPRINT temp is indicated for the fabrication of temporary dental restorations in conjunction with extra-oral curing light equipment. Duration is less than 30 days in oral environment.

FREEPRINT temp is a family of light-cured-component materials for the Digital Light Processing (DLP)-printing of temporary Crowns & Bridges (C&B) material. It is stored in 500 and 1000ml HDPE bottles. It contains materials with colours of A1, A2, and A3 based on the shade guide. This Product is a liquid photo-curable material that is polymerized by UV laser at 385nm. It can be used to make a tooth model with a photo-curable polymer that is cured by ultraviolet light. The liquid UV curing resin is cured at a specific wavelength (385nm) by the photo-initiator contained in the resin. This device can be manufactured with 3D stereolithographic printer with 385nm wavelength lightsource. Curing in a 3D printer is related to the conditions of the printer equipment and is typically 50µm in thickness. Output resolution ranges from 34µm to 75µm on the x, y axis.

I am sorry, but based on the provided text, there is no information about a study that uses AI or machine learning, or medical image analysis. This document is a 510(k) premarket notification for a dental resin called FREEPRINT temp, used for fabricating temporary dental restorations.

The document discusses the device's indications for use, technological characteristics, and comparison to a predicate device. It also mentions performance testing (against ISO standards) and biocompatibility testing, but these are standard tests for physical materials and do not involve AI or medical image analysis.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance related to AI/ML.

Ask a specific question about this device