Device Dossier

Fixture/appliance dental drill, reusable

Device Dossier for Fixture/appliance dental drill, reusable (Fixture/appliance dental drill, reusable, Class IIa, sponsor Compliance Management…

Intended purpose

The device is a sharp, reusable, rotary surgical instrument designed to be attached to a motorized dental handpiece (e.g., a surgical contra-angle) to cut, shape, and prepare a specific site in the jawbone (osteotomy) for the subsequent placement and fixation of a dental implant. The rotary instruments are intended to be connected to an active device. The devices are surgically invasive and intended for transient use.