Device Dossier

Surgical procedure kit, dental, non-medicated, reusable

Device Dossier for Surgical procedure kit, dental, non-medicated, reusable (Surgical procedure kit, dental, non-medicated, reusable, Class IIa, sponsor…

Intended purpose

Instruments are intended to be used for planning, placement, maintenance and explanation of the implants from dental implant system. Indicated for use is in surgical and restorative application for placement in the bone of upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

TGA Public Summary