A Conical Connection Implant MAKE IT SIMPLE

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1 A Conical Connection Implant MAKE IT SIMPLE

2 P. 4-5 P. 6-7 P. 8-9 P P P P P P P P P. 28 P. 29 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. Warning: Products should be used by licensed dentists only.

3 Table of contents. Introduction Advantages Surface Quality Narrow Implants (Ø3.30mm) Standard Implants (Ø3.75mm, Ø4.20mm) Wide Implants (Ø5mm) C1 Surgical Kit Drilling Procedures Dual Stability Mechanism Drill Stopper Kits Insertion Tools Package Contents Packaging

4 4. The C1 implant system is an advanced implant design that offers a unique combination of surgical and restorative benefits, including a differential thread design to ensure superior initial stability in different clinical situations, platform switching and a conical connection with an anti-rotation index. Each C1 implant comes with a single-use final drill to ensure a safer and more accurate drilling procedure. MIS Corporation. All rights reserved.

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6 6. Advantages. Yellow indicates a Narrow platform Advantages. All C1 implants, superstructures and tools are color-coded for simple and immediate identification of the platform size. Green indicates a Wide platform Purple indicates a Standard platform C1 Conical connection implants

7 Prosthetic options A broad range of MIS conical connection prosthetic components presents uncompromising accuracy; a consistent concave emergence profile for excellent soft tissue results; golden shade to support high esthetic results; color coding for simple and immediate platform identification and a positioning groove ensures definite fit over the implant. Platform switching The C1 platform switching keeps the implant-abutment connection away from the bone; minimizing bone resorption. Platform switching additionally allows more vital growth of the soft tissue. Conical connection Featuring a 6-degree conical connection that ensures a secure fit between abutment and implant, the C1 minimizes micro-movements reducing bone loss at the crestal level. It has is a six-position cone index within the conical connection to help orient the implant during insertion as well as placing the abutment into the proper position. Micro-rings At the neck of the C1, micro-rings significantly increase the BIC (Bone to Implant Contact), avoiding bone resorption at the crestal zone. Dual thread The C1 dual thread design increases the BIC (Bone to Implant Contact) over the entire body of the implant. The dual thread doubles the implant insertion rate (1.50mm), facilitating a simpler and faster implant placement. Conical shape With its conical, root-shaped geometry and a unique thread design, C1 ensures a superior primary stability and offers the ultimate choice for a wide range of clinical cases and loading protocols Its root-shaped design makes C1 ideal for narrow spaces, restricted by adjacent teeth or implants. Two spiral channels and domed apex The C1 features a domed apex, providing a high tolerance and safe procedure during insertion. Two cutting blades at the implant apex establish the selftapping properties of the C1; supporting a simpler, safer and faster procedure.

8 8. Advantages. Surface Quality. C1 implants are sand-blasted and acid-etched. These surface treatments increase the implant surface area by creating both micro and nano-structures and eliminating various surface contaminants. The surface of MIS implants was found superior in its purity compared to other implant systems by two independent researches, as published in the POSEIDO Journal and in EDI Journal.

9 2015/1 SURFACE ANALYSIS OF STERILE-PACKAGED IMPLANTS Dr. Dirk Duddeck and Dr. Jörg Neugebauer, PhD For the third time in a row, the Quality and Research (Q&R) Committee of BDIZ EDI is examining sterilepackaged implants under the scanning electron microscope for the more than 5,500 members of the association. In cooperation with the University Hospital of Cologne, extensive qualitative and quantitative elemental analyses are performed on each of the implants studied. In 2009/2008, the surfaces of 23 implants were analyzed, a number that had grown to 54 different implants from manufacturers in nine countries by 2012/2011. Here, isolated implants showed residue from the manufacturing and/or packaging process, pecularities in the external threading or residual filings inside the implant. 65 dental implants from different leading manufacturers underwent topographical and chemical composition analysis. The protocol included the use of a Scanning Electron Microscope (SEM), which enabled the topical evaluation of each implant surface. The high sensitivity backscattered electron detector generates images in compositional and topographical modes to a magnification of up to X5,000 for this study. The BSE detector also allows researchers to draw conclusions about the chemical nature and allocation of remnants or contaminants on the sample material. Qualitative and quantitative analyses of implant surfaces were done using Energy Dispersive X-ray Spectroscopy (EDX). This element identification software even allows the identification of elements deep within the sample. Testing on MIS implants revealed percentages of Titanium, Oxygen, Aluminum and Vanadium. Conclusions reached in the study state: "The C1 implant and the Seven implant (both MIS) stood out positively in the current study. Whereas during the 2012/2011 study, the Seven implant still exhibited blasting material on up to seven per cent of the surface, the current study did not even find isolated spots with residue on the two MIS implant types of grade 23 titanium (Ti 6Al4-V ELI)". Residue-free surface, MIS C1 implant (x 1000). MIS C1 implant surface with micro-nano-structure (x 2,500). MIS C1 implant side-view of a thread (x 2,000). The study is available for download from the MIS Website: Surface Analysis of Sterile-Packaged Implants: EDI Journal, Issue 2015/1:

10 10. Screw type implant range Narrow Platform Length 10mm 11.50mm 13mm 16mm Type C C C C Ø3.30 mm Surgical Tools CT-NLI10 CT-NSI10 CT-NLR10 CT-NSR10 Long insertion tool, conical conn., NP Short insertion tool, conical conn., NP Long ratchet insertion tool, conical conn., NP Short ratchet insertion tool, conical conn., NP Implant cover screw and healing caps CC Gingival heights: 3, 4, 5, 6, 8mm Ø 3.3mm CN-H0333 CN-H0433 CN-H0533 CN-H0633 CN-H0833 Gingival heights: 3, 4, 5, 6, 8mm Ø 4mm CN-HS340 CN-HS440 CN-HS540 CN-HS640 CN-HS840 Gingival heights: 2, 3, 4, 5, 6, 8mm Ø 4.8mm CN-HA248 CN-HA348 CN-HA448 CN-HA548 CN-HA648 CN-HA848

11 Catalog No. Dimensions Ø3.30mm Narrow Platform C Ø 3.30mm Length 10mm Titanium Alloy Ti 6Al 4V ELI Sand-Blasted and Acid-Etched C Ø 3.30mm Length 11.5mm C Ø 3.30mm Length 13mm Ø2.75 C Ø 3.30mm Length 16mm Ø 3.2 Ø 3.30 Ø2.4 Ø 2.50 * The implant package includes: a cover screw, temporary cylinder and a final drill Single-use final drill A specially designed final drill for 10mm, 11.50mm, 13mm and 16mm implants is supplied with every implant, allowing a short, sterile and safe drilling procedure. This final drill should not be used in type 4 bone. Ø3.30mm Implant Procedure Drilling Speed (RPM) Diameter Ø1.90 Ø2.40 Ø2.40 Ø3 Ø3.60 Ø3.30 Final drill For bone type 1,2&3 Do not use the final drill for bone type 4 The drilling sequence is illustrated using a 13mm implant. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon.

12 12. Screw type implant range Standard Platform Length 8mm 10mm 11.50mm 13mm 16mm Type C C C C C Ø3.75 mm C C C C C Ø4.20 mm Surgical Tools CT-SLI10 CT-SSI10 CT-SLR10 CT-SSR10 Long insertion tool, conical conn., SP Short insertion tool, conical conn., SP Long ratchet insertion tool, conical conn., SP Short ratchet insertion tool, conical conn., SP Implant cover screw and healing caps CC Gingival heights: 3, 4, 5, 6, 8mm Ø 3.9mm CS-H0339 CS-H0439 CS-H0539 CS-H0639 CS-H0839 Gingival heights: 2, 3, 4, 5, 6, 8mm Ø 4.8mm CS-HS248 CS-HS348 CS-HS448 CS-HS548 CS-HS648 CS-HS848 Gingival heights: 3, 4, 5, 6, 8mm Ø 5.8mm VS-HS358 VS-HS458 VS-HS558 VS-HS658 VS-HS858

13 Catalog No. Dimensions Ø3.75mm Standard Platform C Ø 3.75mm Length 8mm Titanium Alloy Ti 6Al 4V ELI Sand-Blasted and Acid-Etched C Ø 3.75mm Length 10mm C Ø 3.75mm Length 11.50mm Ø3.15 C Ø 3.75mm Length 13mm Ø 3.60 Ø 3.75 C Ø 3.75mm Length 16mm Ø3 Ø 3.10 Single-use final drill A specially designed final drill for 8mm, 10mm, 11.50mm, 13mm and 16mm implants is supplied with every implant, allowing a short, sterile and safe drilling procedure. This final drill should not be used in type 4 bone. * The implant package includes: a cover screw, temporary cylinder and a final drill Ø3.75mm Implant Procedure Drilling Speed (RPM) Diameter Ø1.90 Ø2.40 Ø2.40 Ø3 Ø3 Ø3 Ø3.60 Ø3.75 Final drill For bone type 1,2&3 Do not use the final drill for bone type 4 The drilling sequence is illustrated using a 13mm implant. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon.

14 14. Catalog No. Dimensions Ø4.20mm Standard Platform C Ø 4.20mm Length 8mm Titanium Alloy Ti 6Al 4V ELI Sand-Blasted and Acid-Etched C Ø 4.20mm Length 10mm C Ø 4.20mm Length 11.50mm Ø3.15 C Ø 4.20mm Length 13mm Ø4 Ø 4.20 C Ø 4.20mm Length 16mm Ø3.50 Ø 3.60 Single-use final drill A specially designed final drill for 8mm, 10mm, 11.50mm, 13mm and 16mm implants is supplied with every implant, allowing a short, sterile and safe drilling procedure. This final drill should not be used in type 4 bone. * The implant package includes: a cover screw, temporary cylinder and a final drill Ø4.20mm Implant Procedure Drilling Speed (RPM) Diameter Ø1.90 Ø Ø2.40 Ø Ø3.50 Ø Ø3.50 Ø Ø4.20 Final drill For bone type 1,2&3 Do not use the final drill for bone type 4 The drilling sequence is illustrated using a 13mm implant. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon.

15 Screw type implant range Wide Platform Length 8mm 10mm 11.50mm 13mm 16mm Type C C C C C Ø5 mm Surgical Tools CT-WLI10 CT-WSI10 CT-WLR10 CT-WSR10 Long insertion tool, conical conn., WP Short insertion tool, conical conn., WP Long ratchet insertion tool, conical conn., WP Short ratchet insertion tool, conical conn., WP Implant cover screw and healing caps CC Gingival heights: 3, 4, 5, 6mm Ø 5.5mm CW-HS355 CW-HS455 CW-HS555 CW-HS655 Gingival heights: 2, 3, 5mm Ø6.3mm CW-HA263 CW-HA363 CW-HA563

16 16. Catalog No. Dimensions Ø5mm Wide Platform C Ø 5mm Length 8mm Titanium Alloy Ti 6Al 4V ELI Sand-Blasted and Acid-Etched C Ø 5mm Length 10mm C Ø 5mm Length 11.50mm Ø4 C Ø 5mm Length 13mm Ø 4.90 Ø 5 C Ø5mm Length 16mm Ø 4.10 Ø 4.50 Single-use final drill A specially designed final drill for 8mm, 10mm, 11.50mm, 13mm and 16mm implants is supplied with every implant, allowing a short, sterile and safe drilling procedure. This final drill should not be used in type 4 bone. * The implant package includes: a cover screw, temporary cylinder and a final drill Ø5mm Implant Procedure Drilling Speed (RPM) Diameter Ø Ø Ø2.40 Ø3 Ø Ø4 Ø Ø4.10 Ø Ø5 Final drill For bone type 1,2&3 Do not use the final drill for bone type 4 The drilling sequence is illustrated using a 13mm implant. Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon.

17 C1 Surgical Kit The C1 surgical kit comprises a complete range of drills and tools required for C1 implant placement procedures. It features a convenient ergonomic layout that follows the surgical drilling sequence, and includes a set of length-based pilot drills for a smoother, more accurate procedure. Kit components are color-coded for immediate identification of diameters for both implants and restorative platforms.

18 C1 Surgical Kit 32 8 MK-0044 With external irrigation drills MARKING DRILLS PILOT DRILLS STEP DRILLS BODY TRY-INS 1 MT-TDN19 Marking drill, Ø1.90mm external irrigation 3 CT-P2408 Pilot drill with built-in stopper Ø2.4/2.0mm, height 8mm 8 CT-TDC30 Step drill, Ø3/2.4mm, external irrigation 12 CT-BTC24 Body try-in, Ø2.40mm 2 MT-SMD10 Spade marking drill 4 CT-P2410 Pilot drill with built-in stopper Ø2.4/2.0mm, height 10mm 9 CT-TDC35 Step drill, Ø3.5/3mm, external irrigation 13 CT-BTC30 Body try-in, Ø3mm 5 CT-P2411 Pilot drill with built-in stopper Ø2.4/2.0mm, height 11.5mm 10 CT-TDC40 Step drill, Ø4/3.5mm, external irrigation 14 CT-BTC35 Body try-in, Ø3.50mm 6 CT-P2413 Pilot drill with built-in stopper, Ø2.4/2.0mm, height 13mm 11 CT-TDC45 Step drill, Ø4.5/4mm, external irrigation 15 CT-BTC40 Body try-in, Ø4mm 7 CT-P2416 Pilot drill, Ø2.4/2.0mm, height 16mm 16 CT-BTC45 Body try-in, Ø4.5mm

19 SURGICAL TOOLS MT-PP240 Parallel pin, Ø2.40/3mm MT-DE001 Drill extender 34 MT-RT070 Torque Ratchet for implant placement MT-RE160 Int. connection abutment extractor, NP 36 5 MT-RE172 Int. connection abutment extractor, SP MT-RDL30 Long hex. drive for 0.05 inch MT-RDS30 Short hex. drive for 0.05 inch COUNTERSINKS INSERTION TOOLS MT-CSN33 Countersink, NP CT-NSR10 Short ratchet insertion tool, conical conn., NP CT-SSR10 Short ratchet insertion tool, conical conn., SP CT-WSR10 Short ratchet insertion tool,conical conn., WP 18 MT-GDN33 Countersink, SP 21 CT-NLR10 Long ratchet insertion tool, conical conn., NP 25 CT-SLR10 Long ratchet insertion tool, conical conn., SP 29 CT-WLR10 Long ratchet insertion tool, conical conn., WP 19 MT-GDN50 Countersink, WP 22 CT-NSI10 Short insertion tool, conical conn., NP 26 CT-SSI10 Short insertion tool, conical conn., SP 30 CT-WSI10 Short insertion tool, conical conn., WP 23 CT-NLI10 Long insertion tool, conical conn., NP 27 CT-SLI10 Long insertion tool, conical conn., SP 31 CT-WLI10 Long insertion tool, conical conn., WP

20 20. Drilling Procedures. Initial surgical steps are common for all implant diameters. Additional steps are required as the implant diameter increases. Ø3.75 SPADE / MARKING DRILL Ø1.90mm PILOT DRILL Ø2.40mm BODY TRY-IN Ø2.40mm TWIST DRILL 3mm BODY TRY-IN Ø3mm FINAL DRILL TWIST DRILL 3.50mm BODY TRY-IN Ø2.40mm TWIST DRILL 3mm SPADE / MARKING DRILL Ø1.90mm PILOT DRILL Ø2.40mm Ø4.20 BODY TRY-IN Ø3.5mm FINAL DRILL C1 IMPLANT PILOT DRILL Ø2.40mm BODY TRY-IN Ø2.40mm FINAL DRILL Ø3.30 SPADE / MARKING DRILL Ø1.90mm FINAL DRILL BODY TRY-IN Ø4mm TWIST DRILL 4mm TWIST DRILL 3.50mm TWIST DRILL 3mm BODY TRY-IN Ø2.40mm PILOT DRILL Ø2.40m SPADE / MARKING DRILL Ø1.90mm Ø5 Procedure recommended by MIS cannot replace the judgment and professional experience of the surgeon.

21 STANDARD NARROW WIDE Ø1.90 Ø2.40 Ø2.40 Ø3 Ø3 Ø3.50 Ø3.50 Ø4 Ø4 Procedure Tools Description. Final drill Body try-in Ø4mm Body try-in Ø3.50mm Twist drill 4mm, external irrigation Twist drill 3.50mm, external irrigation Body try-in Ø3mm Twist drill 3mm, external irrigation Body try-in Ø2.40mm Pilot drill Ø2.40mm Spade / marking drill Ø1.90mm

22 The Dual Stability Mechanism The C1 offers a Dual Stability Mechanism ( DSM ) that combines the benefits of high primary stability with an accelerated osseointegration process, thus minimizing stability loss during the first weeks after M surgery. This differential drilling method enables moderate compression of the bone at the top 2/3 of the implant body in order to gain mechanical stability, while preventing such compression at the apical 1/3. AL ANIC STABIL H ITY EC Thanks a Thanks to a to unique unique drilling methodology, drilling methodology, the implant's the implant's geometric design geometric design enables a moderate enables a moderate compression compression thetop bone 2/3 of the bone atofthe 2/3atofthe itstop body. ofthis the body. This compression, congestion, enabledenabled by a by a distinctive conical shaped final drill, distinctive conical shaped final drill, provides an immediate and prolonged provides an immediate and prolonged mechanical mechanical primary stability. primary stability.

23 The 'compartments' created between the threads at the apical 1/3 are filled with blood and bone particles, enabling rapid bone growth. ICAL STABI OG LIT L O Y I B An enhanced An enhanced secondary secondary biological stability biological stability is achieved by is achieved by integration of the integration of the implant's geometry, implant's geometry, morphology and morphology and a differential drilling a differential drilling approach. The approach. The compartments formed compartments formed between the between the implant's threads at the bottom implant's threads at thean bottom 1/3 of 1/3 of the cavity generate ideal habitat thesustainable cavity, generate ideal leading habitat for bonean growth foraccelerated sustainable bone growth to osseointegration. leading to an accelerated osseointegration.

24 24. Drill Stoppers Kit Standard Platform. MK-BC101 Following the use of MIS lengthbased pilot drills, the C1 Standard Platform Stoppers Kit ensures drilling to the exact desired depth. The kit includes the most commonly used lengths: 8, 10, 11.5 and 13mm. Stoppers Four sleeves for each diameter in 8, 10, 11.5 and 13mm lengths, color-coded according to drills. Box The tray can be removed from the box for ease of use. Scale Teflon IN Insert Teflon OUT Insert Simple. Quick, easy assembly. Kit Contents Ø3 stoppers (for Ø3.75mm implants) Ø3.50 stoppers (for Ø4.20mm implants) Easy. Color-coding for quick identification of the sleeve diameter. Safe. Safe drilling to desired depth. Fast. Clearly arranged depth sleeves for quick and easy identification of 8-13mm lengths and Ø3, Ø3.5mm diameter stoppers.

25 Following the use of MIS lengthbased pilot drills, the C1 Drill Stoppers Kit enables safe and easy drilling to the exact desired depth. MIS offers 4 different kits in lengths of: 8, 10, 11.5 and 13mm. Drill Stoppers Kit Depth Based. Stoppers Five sleeves 3.0, 3.5, 4, 4.5 and 5mm diameters, color-coded according to drills. Box The tray can be removed from the box for ease of use. 8mm 10mm 11.5mm 13mm Desired drilling depth Scale Teflon IN Insert Teflon OUT Insert Simple. Quick, easy assembly. Kit Contents For 8mm implants MK-CDS08 For 10mm implants MK-CDS10 Easy. Color coding for a quick identification of sleeve diameter. Safe. Safe drilling to desired depth. For 11.5mm implants MK-CDS11 For 13mm implants MK-CDS13 Fast. Clearly arranged depth sleeves for quick and easy identification of Ø3mm to Ø5mm diameter drills.

26 Standard platform tools shown Insertion Tools. C1 implant placement tools are specially designed to facilitate quick and reliable implant procedures. Long insertion tool, SP Short insertion tool, SP Long ratchet insertion tool, SP Short ratchet insertion tool, SP Long drive for 0.05 inch hex. Short drive for 0.05 inch hex. CT-SSR10 CT-SLR10 CT-SSI10 MT-RDL30 CT-SLI10 MT-RDS30

27 20. 2 MIS offers a line of specially engineered insertion tools suitable for use either manually or with the unique insertion tool system, which allows secure implant placement without the use of a mount, effectively reducing the number of tools required in the armamentarium. 1 3 Insertion options: 1 Insertion tool in manual use 2 Insertion tool for motor 3 Insertion tool in ratchet wrench Please note: In order to assure their efficient operation, tools should be fully inserted into the implants. A complete insertion of the tool optimizes the transfer of force during implant placement and enables simple release of the tool from the hex. whenever necessary. Tool will not hold implant unless it is completely inserted into the hex.

28 28. Package Contents. Each C1 implant comes with sterilized components for multiple clinical scenarios. Following the "Make It Simple" philosophy, MIS is proud to be the first to present a comprehensive tool set which includes: a single-use final drill, a cover screw and a temporary cylinder with every C1 implant, meeting all your clinical needs. Cover Screw Temporary Cylinder Implant Final Drill Inner Tube Outer Tube

29 12. Implant diameter & platform indication The outer tube is color-coded indicating the implant platform. The numeric indication specifies the implant diameter and length. Packaging. Prosthetic platform indication Prosthetic components are marked by specific colors, representing platform sizes. Providing a simple, immediate identification of implant type, length and diameter, the C1 package is well designed for ease of use during surgery. A double packing system ensures sterilization and safety. Packages are designed for ease of use during surgery and for use with surgical gloves. Implant identification markings Quick identification of implant size and length. Sticker on the box lid, specifies implant diameter, length and platform size. Easy pull tab The convenient pull tab facilitates quick and easy opening during surgery.

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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.

32 MC-UNO08 MC-CONEN Rev.13 MIS Implants Technologies Ltd. MIS Implants Technologies Ltd The MIS Quality System complies with international quality standards: ISO 13485: Quality Management System for Medical Devices, ISO 9001: Quality Management System and CE Directive for Medical Devices 93/42/EEC. MIS products are cleared for marketing in the USA and CE approved Authorized European Representative: MIS Germany, Paulinenstraße 12a, Minden, GERMANY MIS Corporation. All rights reserved. MIS Corporation. All Rights Reserved.

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