Main Performance Characteristics; Regulations And Standards; Official Texts; Medical Class Of The Device - Ultradent Ultrawave Manuel D'utilisation

8.5 Main performance characteristics

Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece.
• Tip amplitude ≤ 200 µm.

9 Regulations and standards

9.1 Official Texts

This medical device complies with the essential requirements of European Directive 93/42/EEC. This equipment is designed and developed in
compliance with Electrical Safety standard IEC60601-1 in force. It was designed and manufactured in accordance with an EN ISO 13485-certified
quality assurance system.

9.2 Medical class of the device

This medical device is a class IIa device according to European Directive 93/42/EEC.

9.3 Standardized Symbols

14 J12109 • V1 • (14) • 03/2014 • NB22US010B