Device Dossier

Surgical implant template, reusable

Device Dossier for Surgical implant template, reusable (Surgical implant template, reusable, Class IIa, sponsor Compliance Management Solutions). ARTG…

Intended purpose

The device is a rigid or semi-rigid, reusable surgical instrument and its primary purpose is to precisely guide surgical instruments (such as dental drills, bone taps, or saws) according to a predefined plan, and/or to verify the specific orientation, depth, alignment, and fit of an implant or anatomical structures. The rotary instruments are intended to be connected to an active device. The devices are surgically invasive and intended for transient use.