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2 MIS Warranty: MIS exercises great care and effort in maintaining the superior quality of its products. All MIS products are guaranteed to be free from defects in material and workmanship. However, should a customer find fault with any MIS product after using it according to the directions, the defective product will be replaced.

3 contents: Overview Step 1: Preliminary impression. Step 2: Template Fabrication. Step 3: Occlusal Guide. Step 4: Template try-in. Step 5: Radiology information. Step 6: MIS interactive planning. Step 7: Confirmation of MGuide plans. Step 8: Sleeve insertion. Step 9: Implant placement Restorative tools MGuide Order forms.

4 Liability. In no event shall MIS be liable for indirect or consequential damages. The products furnished by MIS are not intended to be used to determine diagnosis, prognosis, or a course of treatment. Neither the products or any information made available by MIS are intended to replace the services of a trained professional or to be substitute for medical advise by physicians. MIS makes no representations or warranties with respect to the products regarding treatment, action, or application of medication.

5 5. Introduction. MIS is proud to offer virtual implant planning and guided impantology. The advantages of these cutting edge technologies for the clinician and for the patient are immense. Advances in radiology,such as cone beam scanning devices, are able to produce exceptionally accurate images and precise digital data collection. Another important advancement is the creation of imaging software. This advanced software can accurately transform the digital data (DICOM) into 2D and 3D images that accurately depict the real world in a virtual environment.

6 6. Clinician Preliminary impression Step1 Upon completion of the pre-surgical protocol and upon agreement of the treatment plan, preliminary impressions of the patient are taken and sent to the dental laboratory for the casting of diagnostic models....the fabrication of the Radiopaque templates will be done according to the instruction of a licensed clinician.

7 Step 1 Partial dentures Full dentures Partially edentulous maxilla Edentulous maxilla Alginate impression Custum tray Master model Master model

8 8. Laboratory / Clinician Template Fabrication Step2 Radiopaque templates serve many functions, they are used by the clinician as a diagnostic tool where phonetics, asthetics and function will be checked. They will be an aid in the planning of implant positioning, and will be the guide through which the clinician will place the implants. The fabrication of the Radiopaque templates will be done according to the instruction of a licensed clinician. Illustrated are suggested fabrication of a partially edentulous and edentulous case....preliminary impressions of the patient are taken and sent to the dental laboratory...

9 Diagnostic denture fabrication. A wax up of the requested prosthesis is fabricated as accurately as possible. The template copied from the prosthesis will determine the position and angulation of the implants and abutments. A silicone impression was taken to duplicate the wax up. The denture teeth will be duplicated in Barium sulfate,4:1 ration of polymer to barium sulfate by weight. Partial dentures Full dentures Step 2 Partial denture wax up Full denture wax up Silicone index of partial denture Silicone index of full denture Barium sulfate poured into silicone index Barium sulfate poured into silicone index

10 Radio opaque teeth. The polymerized barium sulfate teeth should be separated inter proximally so that the tooth borders will be distinguishable in the CT scan Polymerization should be carried out in a pressure device at 2 bar of pressure at approximately 45 0 c / f for 15 minutes. Partial dentures Full dentures Barium sulfate teeth after polymerization Barium sulfate teeth after polymerization Polymerization of denture base with barium sulfate teeth Polymerization of denture base with barium sulfate teeth Polymerized partial denture with barium sulfate teeth Polymerized denture base with barium sulfate teeth

11 Registration markers. A thin 2x3x1 Lego brick (registration marker) is polymerized onto the acrylic denture base. Placement of this marker is very important and is determined by the presents of objects that can cause artifacts in the CT scan. Safety marker are added in buccal areas of the template with self curing acrylic. The safety markers should be placed in such a way that they will be about implant level but will not interfere with template casting. Partial dentures Full dentures Step 2 Template without registration marker or safety pins Template without registration marker or safety pins Template with thin Lego brick Template with thin Lego brick Large registration marker and safety pins placement Safety makers made of barium sulfate or guta percha pins

12 12. Laboratory Occlusal Guide Step3 It is advised that any type of bite registration device be used and incorporated on the template. These devices, such as duralay posts, will aid in immobilizing the jaws in order to ensure that there is no movement of the patient during the CT scan, and to mimic the position of the mouth during surgery, in effort to establish enough room for the dental surgeon to work in....mimic the position of the mouth during surgery, in effort to establish enough room for the dental surgeon to work in.

13 Radiological guide with references and occlusal stops Step 3

14 14. Clinician Template try-in Step4 Upon receipt of the template in the dental office, it should be checked for the presents of the Lego block and safety markers. It is very important that the template seats perfectly in the mouth. For tooth borne templates inspection windows can be included. Optimally we want the relation of the patients mouth to be the same for the CT scan as for the surgery....it is very important that the template seats perfectly in the mouth.

15 Lego block and safety markers Step 4

16 16. Radiologist Radiology information Step5 CT scan should be extremely precise and there should be absolutely no movement of the patient during the CT scan. Verification of the complete seating of the template is imperative....bottom of the Maxillary sinus should be visible.

17 1. Patients mouth should be fully opened and completely stabilized. 2. Large Lego brick must be present and shown in full on the CT image. Is an important reference marker. 3. Upper and or lower jaws shown in full. 4. Bottom of the Maxillary sinus should be visible. 5. Naming of case should include,patients name, differentiation between upper and lower jaws if separate CT's were taken, and clinicians name. 6. Non-compressed CT DICOM data should be burned on CD and sent to the clinician. Step 5 Placing the anatomic abutment on the stone model

18 18. (MIS Center) MIS interactive planning Step6 MIS centers will carry out the initial interactive planning of implants using 2D and 3D visualization software....the prescription (Rx) will detail the intended restoration sights.

19 The MIS Center must receive from the clinician the following: A non-compressed DICOM CD. Template, complete with Lego block and safety markers. A prescription(rx) of the case that will include the patients name,date of birth, ID number and Ct scan number. The prescription (Rx) will detail the intended restoration sights. Step 6 2D and 3D visualization software

20 20. Clinician Confirmation of MGuide plans Step Upon completion of the initial planning, the MIS center will send to the clinician the plans to be evaluated. The clinician will check the plausibility, and feasibility of the plans. Upon agreement the MIS Center will send the clinician the surgical plan to be validated and signed....the clinician will check the plausibility

21 MGuide plan Step 7

22 22. (MIS Center) Sleeve insertion Step8 This is the final stage in which the MIS center completes the insertion of the titanium sleeves in the template. The selected MIS implants and MIS tools will be packaged and sent to the clinician with the template and the MIS surgical guide chart....the selected MIS implants and MIS tools will be packaged and sent to the clinician with the template and the MIS surgical guide chart.

23 Sleeve insertion Step 8

24 9 24. Clinician Implant placement Step Before beginning the implant procedure the clinician should double check the MIS surgical guide chart and the template. The MIS implants are then set according to the MIS surgical guide chart, using the template and MIS tools....double check the MIS surgical guide chart

25 MGuide plan Step 9

26 26. MGuide Tools Clinician & MGuide Surgical Kit MK-0038 Color coding:

27 MGuide Surgical Kit Tools (All tools can be purchased separately or by the Kit) L MT-MII08 MGuide Implant insert lenght 14.60mm MT-MII10 lenght 12.60mm MT-MII11 lenght 11.10mm MT-MII13 lenght 9.60mm MT-MII16 lenght 6.60mm MT-DS200 MT-DS280 MT-DS320 MT-DS380 MT-DS450 Drill guidance key MT-TDL20 MT-TDL28 MT-TDL32 MT-TDL38 MT-TDL45 Long pilot drill 2 Long twist drill MT-TP420 Tissue punch 4.20 MT-LCS37 MT-LCS42 MT-LCS50 Countersink (for 3.30/3.75 dia. imp.) 3.70 Countersink (for 4.20 dia. imp.) 4.20 Long countersink (for 5 dia. imp.) 5 MCenter Tools MT-PG040 Insertion chuck height 4mm MT-TD630 Template drill 6.30 MT-LS040 Main guide sleeve height 4mm MT-RODQ1 Q1 rod lenght 100mm MT-TD110 Marking drill 1.90mm 1.90

28 28. MGuide Tracking Form Dentists name Patients name DICOM received date CT institute DICOM Uploading date

29 Distribution of clinical key Virtual planing by Dentist Sleeve insertion Surgical kit Collection of clinical key Date Disk on key Internet Date Supplied Y/N Date

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31 All rights reserved. No part of this publication may be reproduced, transcribed, stored in an electronic retrieval system, translated into any language or computer language, or be transmitted in any form whatsoever, without the prior written consent of the publisher. Warning: Only a licensed Clinician should use these products.

32 MC-MG001 Rev.2 MIS Implants Technologies Ltd ISO 9001:2000 ISO 13485:2003 Authorized European Representative: MIS Germany, Paulinenstra e 12a, Minden, GERMANY