Device Dossier

Screwdriver, surgical

Device Dossier for Screwdriver, surgical (Screwdriver, surgical, Class IIa, sponsor Compliance Management Solutions). ARTG record, intended purpose, GMDN…

Intended purpose

The device is a non-powered, reusable surgical instrument intended to apply manual or motorized rotation to introduce, tighten, loosen, or remove screws, implants, and prosthetic components during dental implant and restorative procedures. The rotary instruments are intended to be connected to a Class IIa active device. The devices are surgically invasive and intended for transient use.