Device Dossier

Orthodontic anchoring screw

Device Dossier for Orthodontic anchoring screw (Orthodontic anchoring screw, Class IIb, sponsor Compliance Management Solutions). ARTG record, intended…

Intended purpose

BT SCREW are supplied in two configurations: BT SCREW (smooth/machined) and BT SCREW ETCHED. The latter have a rough surface obtained by an etching process. Cortical screws BT SCREW, which are the subject of this documentation, are an integral part of implantation and bone regeneration therapy, now widely used in the dental field. In fact, they can be used in bone reconstruction procedures, in the mandible or jaw area, or in particular cases of edentulism. In particular they are designed to fix devices to the surgical site, such as subperiosteal implants, bone regeneration mesh and bone grafts. It is therefore a device that is used together with other medical devices. In case of use with subperiosteal systems, the device remains in place for the entire life of the patient. In case of use with bone regeneration grids or bone grafts, the cortical screws are intended to be removed after a variable period, decided by the clinician, corresponding to the achievement of bone regeneration of the surgical site, which is typically between 6 and 12 months. BT SCREW ETCHED are intended to be used in combination with devices intended to remain in situ for the entire life of the patient. PINS are indicated for fixing resorbable and non-resorbable membranes.

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