Device Dossier

Scaler system handpiece, periodontic, ultrasonic

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

Intended purpose

Ultrasonic dental scaling/debridement system handpiece; A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.

TGA Public Summary