666015 Rev. A

SURGICAL MANUAL IMPORTANT

This surgical manual serves as a reference for using the Sterngold Guided Surgery Kit. It is only intended to provide instructions on the use of Sterngold TRU® & PUR® implants and its complementary products. It is not intended to describe the methods or procedures for diagnosis, treatment planning, or placement of implants, nor does it replace clinical training or a clinician’s best judgment regarding the needs of each patient. Sterngold strongly recommends appropriate training as a prerequisite for the placement of dental implants and associated treatment. The procedures described within this manual reflect idealized patient presentations with adequate bone and soft tissue to accommodate implant placement. No attempt has been made to cover the wide range of actual patient conditions that may adversely affect surgical and prosthetic outcomes. Clinician judgment as related to any specific case must always supersede any recommendations made in this or any Sterngold literature.

Before beginning any dental implant surgical procedure using the Sterngold Guided Surgery Kit:

• Carefully select patient after thorough clinical evaluation of medical and dental history. • Read and understand the Instructions for Use that accompany TRU® & PUR® dental implants and its complementary implant products. • Clean and sterilize the surgical tray and instruments following the Instructions for Use. • Become thoroughly familiar with all the instruments within the kit as well as complimentary instruments not included in the kit, and their uses. • Design a surgical treatment plan to satisfy the prosthetic requirements of the case.

INDICATIONS

The Sterngold TRU® & PUR® Keyless Fully Guided Surgery Kit is to be used solely with Sterngold TRU® & PUR® implants. The kit is intended to be used for dental implant applications including oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible to support single unit, and multiple unit restorations. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. TRU® & PUR® implants are intended for delayed or immediate loading when adequate primary stability appropriate occlusal loading is achieved clinically. Patient selection should be such that there are no compromising health conditions, disease, or medications that would interfere with the complete integration of the implants into the bone. Adequate bone quality and quantity should be assessed as well as available vertical opening to allow for kit instruments to be used.

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