CANCELLED - 3Shape TRIOS

Intended Use
The TRIOS intra-oral scanner is an optical impression system (CAD/CAM) used to record 3D digital images of the topographical characteristics of teeth directly from the patient’s mouth - for use with CAD/CAM dental restoration design and production of dental indications as well as orthodontics.
Intended User Profile
The TRIOS intra-oral scanner is operated by trained dental professionals and qualified personnel.
Intended Patient Profile
The TRIOS intra-oral scanner is operated on adult humans. The patient must not use a pacemaker or implantable cardioverter defibrillator (ICD).
Intended Conditions of Use
The TRIOS intra-oral scanner is to be used in standard dentist clinics, typically about 1-10 times a day. Each session normally takes less than 6 minutes for a quadrant case and 12 minutes for a full jaw case.
The system consists of a scanner which acquires the imaging and a base. The base can either be a cart holding a computer and power systems, a pod with power systems and connection to an external PC, or a pod integration also having power systems and connection to an external PC and an interface plate for fixing it to a surface. The cart can be moved around both to optimize the working position and to be used aside multiple chairs in a clinic. The pod is movable by nature due to its small physical dimensions.
The user interacts with the scanner via button(s) on the handheld scanner and possible via a touch screen on the cart or external PC, or a keyboard and mouse or alike human interface devices.