Regulatory; Intended Use; Classifications - Vatech EzScan-i User Manual

requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances
- Requirements and tests:
• IEC 62471, Photobiological safety of lamps and lamp systems

1.5 Regulatory

The EzScan is manufactured and marketed in accordance with US FDA
Regulations and EU Medical Device Regulation 2017/745.

1.6 Intended Use

The EzScan is an optical impression system. It is used to record the
topographical characteristics of teeth, dental impressions, or stone models
for use in the computer-aided design (CAD) and computer-aided
manufacturing (CAM) of dental restorative prosthetic devices.
CAUTION: Rx only - Federal law restricts this device to be sold by or on the
order of a Dentist.
WARNING: Unintended use of the system can result in physical injury to the
patient and operator, and damage to the system.

1.7 Classifications

The EzScan system has the following classifications
Protection against electrical shock: Type B Applied Part
•
Protection against harmful ingress of water: Ordinary equipment
•
(IPX0)
Safety of application in the presence of a flammable anesthetic
•
material with air or with oxygen or nitrous oxide: Equipment not
suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.