DEVICE: Smartlite Pro Endo Activator (D0016444321)

A mains electricity (AC-powered), electromechanical, device typically used to keep substances, e.g., a liquid, liquids, or a combination of particles suspended in these, in a continual motion in order to prevent sedimentation. This device can achieve this by mechanical movement, by ultrasonic means, or other techniques. For devices used during the tapping of blood from blood donors and devices that mix components in the laboratory see the respective GMDN code.

A non-sterile, needle-like endpiece designed to be attached to an ultrasonic dental handpiece and intended to deliver irrigation solution to, and provide debridement of, the root canal by means of ultrasonic mechanical vibration, during an endodontic procedure. This is a single-use device.

A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.