Device Dossier

Drill, dental, fixture/appliance, single-use

Device Dossier for Drill, dental, fixture/appliance, single-use (Drill, dental, fixture/appliance, single-use, Class IIa, sponsor ZimVie). ARTG record,…

Intended purpose

A sterile shaft of metal (a drill bit) intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. It is typically made of a high-grade stainless steel alloy. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical, countersink). It is attached to a motorized handpiece or other power source that provides rotation. This is a single-use device that is intended, in terms of sterility, for a single-patient use.

TGA Public Summary