Research Project
9558628
Project Summary/Abstract In this Phase II SBIR project, Technology Assessment & Transfer, Inc. (TA&T) and their collaborators propose development of ceramic additive manufacturing (AM, aka 3D printing) for production of high performance ceramic dental restorations in the dental laboratory environment. The AM process will utilize low cost desktop printer (< $10,000) to ensure low barrier to entry for early adopters and smaller dental laboratories. Larger labs will benefit from the flexibility of the small modular printers to easily adjust to demand fluctuations. In addition, the additive material cost (estimated < $1 per crown) is substantially lower than CAD/CAM blocks or disks (typ. $10 - $25 per restoration). Finally, the higher native resolution of the additive process compared to CAD/CAM milling will provide restorations with more detail, thereby reducing post process touch time (detailing). The value proposition of this technology is low entry costs, and high cost savings per restoration, which provide a good outlook for market penetration. The specific aims for this Phase II program are to demonstrate that dimensional accuracy, fit, mechanical properties, and aesthetics of additive manufactured restorations meet industry standards. Year 1 will focus on zirconia development with secondary work to move lithium disilicate forward. Year 2 will focus on lithium disilicate restorations. These aims will be achieved by optimizing additive manufacturing materials and processing parameters, and supplying test samples to collaborators to evaluate mechanical properties, dimensional accuracy, accuracy of fit, and esthetics. Throughout the Phase II project, TA&T will engage the FDA through the QSub program to obtain non-binding feedback regarding the regulatory requirements that must be met for 3D printed ceramic restorations. This will guide the development and testing during the project such that upon successful completion most, if not all, of the performance data (ISO 6872) and biocompatibility data (ISO 10993) to show equivalency to predicate devices (zirconia and lithium disilicate milled crowns) will be available for a 510K Premarket Notification of Intent application.
