Device Dossier

Scaler system tip, periodontic, ultrasonic

Device Dossier for Scaler system tip, periodontic, ultrasonic (Scaler system tip, periodontic, ultrasonic, Class IIa, sponsor Emergo). ARTG record,…

Intended purpose

A device (also known as an insert), which is part of an ultrasonic scaler system, that is attached to a dedicated handpiece which together deliver ultrasonic energy (e.g., 25kHz/30kHz) transmitted from the generator to the oral cavity for the removal of accretions from tooth surfaces during oral prophylaxis and periodontal therapy. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is also fed through the handpiece/tip assembly to assist in the process. This device comes in a variety of designs and tip shapes and is reusable.

TGA Public Summary