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 IIb, sponsor…

Intended purpose

SDC provides kits that provide parts to perform the Smart Denture Conversion method on up to six implant sites. Each kit contains components with their own intended purpose. Separable Fasteners are indicated for use with Smart Denture Conversions’ TiBases and screw-retained multiple unit Abutments in the maxilla and mandible. Smart Denture Conversions’ Separable Fasteners are intended for single use. TiBases are indicated for use with screw-retained multiple-unit abutments in the maxilla and mandible. Smart Denture Conversions’ TiBases are intended for single use. The supplied Prosthetic Screws are indicated for use with Smart Denture Conversions’ TiBases and screw-retained multiple-unit abutments in the maxilla and mandible. The supplied Prosthetic Screws are intended for single use and a single patient. The Low Torque Driver is designed for use with tightening Separable Fasteners to a high enough torque to hold the TiBase to the multi-unit abutment, Lab Analog, or Coating Mandrel, but not too much to prematurely separate the Separable Fastener. The Low Torque Driver also has an intended use to unscrew (loosen) Separable Fasteners and Press-On Caps as needed. The supplied Press-On Caps are indicated for use with Smart Denture Conversions’ Threaded Posts (threaded portion of Separable Fastener) and screw-retained multi-unit abutments in the maxilla and mandible. The supplied Retrieval Tool is indicated for use with Smart Denture Conversions’ Threaded Posts (threaded portion of the Separable Fastener) in screw-retained multi-unit abutments in the maxilla and mandible.

TGA Public Summary