Device Dossier

Scaler system tip, periodontic, ultrasonic

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

Intended purpose

Ultrasonic dental scaling/debridement system handpiece tip, periodontal; An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

TGA Public Summary