Dental System 2016-1

Intended Use The Dental System™ Software is intended for recording the topo-graphical characteristics of teeth by scanning physical gypsum models or impression-models of full arch mandibular and maxillary dental arches; storing scanned 3D models and designing dental restorations for use by dentists for patients. Device Description The 3Shape Dental System™ Software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching dental restorative prosthetics using computer aided design. The output of the device is a computer file containing the restoration(s) in digital form which can be used by 3rd party providers of milling machines and/or rapid prototyping machines to manufacture physical prosthetics. The 3Shape Dental System™ Software does not provide any means of creating physical restorations. Both “Crown and Bridge” and Customized Abutments are supported by the device as well as a number of other prosthetic types. The 3Shape Dental System™ Software can be run on properly configured “off-the-shelf” PC hardware running Microsoft® Windows and using a standard keyboard and mouse.