Device Dossier

Screw endosteal dental implant, one-piece

Device Dossier for Screw endosteal dental implant, one-piece (Screw endosteal dental implant, one-piece, Class IIb, sponsor Emergo). ARTG record,…

Intended purpose

Dental implants are indicated for use in surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth or dentures in order to restore the patient chewing function. Therapeutic Indications: To provide support for prosthetic devices, such as artificial teeth or dentures in order to restore patients chewing function. 1) Specific indications for 3.0 diameter implants: Because of their reduced mechanical stability, 3.0 small diameter implants are used only in cases with a low mechanical load such as lateral incisors at the maxilla or incisors at the mandible. Placement in the posterior regions is not recommended. 2) Specific indications for Cortex implants 6 mm length: Because of the reduced surface area for anchorage in the bone, these implants are to be used solely for the following indications: a) As an additional implant together with longer implants to support prosthetic restoration. b) As an auxiliary implant for implant bar constructions supporting full dentures in a seriously atrophied mandible.

TGA Public Summary