The Connection For Predictable Biology - MIS Implants

Transcription

MIS Implants Technologies Ltd. All rights reserved.The Connection for Predictable Biology

2TABLE OFCONTENTSINTRODUCTIONBENEFITSC1 IMPLANT, NARROW PLATFORMC1 IMPLANT, STANDARD PLATFORMC1 IMPLANT, WIDE PLATFORMSURGICAL KITINSERTION TOOLSSURFACE QUALITYPACKAGINGPROSTHETIC OPTIONSMIS CONNECT SYSTEM

3P. 4P. 6-7P. 8-9P. 10-12P. 13-14P. 15-17P. 18-19P. 20-21P. 22-23P. 24-25P. 26MIS Warranty:MIS exercises great care and effort in maintaining superior quality products. All MIS productsare warranted to be free from defects in material and workmanship. However, should a customerfind fault with any MIS product while using it according to the instructions, the defective productwill be replaced.Warning: MIS products should be used by licensed dentists only.

The C1 implant is a powerful player in the MIS conical connection implant fleetand offers a versatile solution for all clinical indications. This simple, accurateand proven implant system was designed with a conical connection andoptimizes biological benefits and clinical and esthetic results.The MIS comprehensive conical connection solution offers:One consistent prosthetic solutionOne surgical kitOne drilling protocolTwo unique geometries of MIS V3 and MIS C1 implant systems provideoptimum implant integration and bone growth.The MIS Quality System complies with international quality standards: ISO 13485: 2016 - Quality ManagementSystem for Medical Devices and Medical Device Directive 93/42/EEC. Please note, not all products are registered oravailable in every country/region.IFUs for MIS products may be found at: https://ifu.mis-implants.com. Adobe Acrobat is required to view the IFU file onthe website. This software may be freely downloaded from the Adobe website.C1 Conical ConnectionImplant on MIS WebsiteAdditional information may be added to the product descriptions without prior notice. MIS Implants Technologies Ltd. All rights reserved.

MIS C1 Product CatalogConical Connection

6BENEFITSBone preservationThe C1 implant incorporates the platform-switching design concept.The 12-degree friction fit conical connection which ensures a secureseal and minimal micro-movements, micro-rings on the implant neckand a platform switched design, were engineered to provide a tightinterface, improved BIC, and soft tissue preservation and growth.Crestal bone loss may be minimized by reducing mechanical traumaand stress in the cortical bone, and gaining soft tissue volume.Maximum accuracyEach C1 package comes with its own sterile, single-use final drill,which is suitable for all bone types increasing the potential for a moreprecise-fit.High initial stabilityThe C1 dual thread design increases the BIC (Bone to Implant Contact)over the entire body of the implant and ensures a safe and controlledinsertion rate. With its conical, root-shaped geometry, the C1 isengineered for high primary stability and offers the ultimate choicefor a wide range of clinical cases and loading protocols.EstheticsA broad range of MIS conical connection prosthetic componentspresents uncompromising accuracy; a consistent concave emergenceprofile for excellent soft tissue results; golden shade to support highesthetic results.Clinical successThe surface roughness and micro-morphology of all MIS implants,is a result of sand-blasting and acid-etching. This MIS establishedsurface technology has provided millions of patients with excellentosseointegration results and long-lasting clinical success, and isbacked by years of research and supporting data.

7Platform switching,designed to faciliate bonepreservation and growthUltimate sealwith ideal conicalconnectionDual design forincreased BIC

8NARROW PLATFORM Implant 330C1-13330C1-16330Surgical ToolsCT-NLI10C1 long motorinsertion tool,narrow platform 10mmCT-NSI10CT-NLR10C1 short motorinsertion tool,narrow platformCT-NSR10C1 long ratchetinsertion tool,narrow platformC1 short ratchetinsertion tool,narrow platformImplant Cover Screw and Healing CapsØ3.3mm3/4/5/6/8mmCover screwØ4.8mmØ HA848

9 Technical Information2.75Ø3.30Ø3.3010, 11.5 , 13 ,16mmØ3.30Material:Titanium Alloy Ti 6Al 4V ELISand-Blasted and Acid-EtchedØ2.50 Ø3.30mm Implant ProcedureBONE TYPEtypes 1 and 2Drilling 0Ø2.40Ø3Ø3.2015-25Ø3.30Bone LevelDo not use the final drill for bone types 4. The drilling sequence is illustrated using a 13mm implant.Procedures recommended by MIS cannot replace the judgment and professional experience of the surgeon.

10STANDARD PLATFORM Implant 10420C1-11420C1-13420C1-16420Surgical ToolsCT-SLI10C1 long motorinsertion tool,standard platformCT-SSI10C1 short motorinsertion tool,standard platformCT-SLR10C1 long ratchetinsertion tool,standard platformCT-SSR10C1 short ratchetinsertion tool,standard platform

11 Implant Cover Screw and Healing CapsØ3.9mm3/4/5/6/8mmCover S-HS858Technical InformationØ3.753.153.15Ø4.20Ø3.75Ø4.208, 10, 11,5, 13, 16mm8, 10, 11.5, 13, 16mm Ø 5.8mmØ4.8mmMaterial:Ø3.10Ø3.60Titanium Alloy Ti 6Al 4V ELISand-Blasted and Acid-Etched

12 Ø3.75mm Implant ProcedureBONE TYPEtypes 1 and 2Drilling 0Ø2.40Ø3200400Ø3Ø3Ø3.6015-25Ø3.75Bone Level Ø4.20mm Implant ProcedureBONE TYPEtypes 1 and 2Drilling 0500700400700Ø3Ø3.50200400Ø3.50Ø3.50Ø4Bone LevelDo not use the final drill for bone types 4. The drilling sequence is illustrated using a 13mm implant.Procedures recommended by MIS cannot replace the judgment and professional experience of the surgeon.15-25Ø4.20

13WIDE PLATFORM Implant 0500C1-11500C1-13500C1-16500Surgical ToolsCT-WLI10CT-WSI10C1 long motorinsertion tool,wide platform C1 short motorinsertion tool,wide platformCT-WLR10C1 long ratchetinsertion tool,wide platformImplant Cover Screw and Healing CapsØ 5.5mmCover screw3/4/5/6mmØ 63CW-HA363CW-HA563CT-WSR10C1 short ratchetinsertion tool,wide platform

14Ø54 Technical Information8, 10, 11.5, 13, 16mmØ5Material:Titanium Alloy Ti 6Al 4V ELISand-Blasted and Acid-EtchedØ4.50 Ø5mm Implant ProcedureBONE TYPEtypes 1 and2 and 3Drilling 0500700400700400600Ø3Ø3.50Ø4200400Ø4Bone LevelDo not use the final drill for bone types 4. The drilling sequence is illustrated using a 13mm implant.Procedures recommended by MIS cannot replace the judgment and professional experience of the surgeon.Ø4.10Ø4.9015-25Ø5

15SURGICAL KITThe innovative Conical Connection Surgical Kit, is designedfor simple and safe implant placement procedures. The kitpresents a novel ergonomic design that follows the surgicaldrilling sequence. In addition, the kit includes a set of lengthbased pilot drills and color-coded visual cues of both implantdiameter and restorative platforms and is suitable for both C1and V3 implants.

1614925936971314151011121617394018844Surgical Kit - MK-T051PILOT DRILLSMARKING DRILLS1MT-SMD10CT-P24085MT-PDM243106141115Pilot drill with built-in stopper for 13mmlength implants, Ø2.4/2mmCT-TDC40Body try-in, Ø3.5mm12CT-P2413Step drill, external irrigation, Ø3.5/3mmCT-BTC35Pilot drill with built-in stopper for 11.5mmlength implants, Ø2.4/2mm7CT-TDC35Body try-in, Ø3mmCT-P2411Position drill, Ø4mmStep drill, external irrigation, Ø3/2.4mmCT-BTC30Pilot drill with built-in stopper for 10mmlength implants, Ø2.4/2mmMT-PD440CT-TDC30Body try-in, Ø2.4mmCT-P2410Position drill mill, Ø2.4mm13CT-BTC24Pilot drill with built-in stopper for 8mmlength implants, Ø2.4/2mmSpade marking drillSTEP DRILLSBODY TRY-INS94245Step drill, external irrigation, Ø4/3.5mm16CT-BTC40MT-CSN33Body try-in, Ø4mmCountersink, narrow platform178CT-P2416MT-GDN33Pilot drill for 16mm length implants,Ø2.4/2mmCountersink, standard platform18MT-GDN50Countersink, wide platform41

C1 INSERTION TOOLS2733CT-NLI10CT-SSI10Long motor insertion tool,conical connection,narrow platform19202122272928283034CT-NLR10CT-SSR10Long ratchet insertion tool,conical connection,narrow platformShort ratchet insertion tool,conical connection,standard platform292324313225263334Short motor insertion tool,conical connection,standard platform35CT-NSI10CT-WLI10Short motor insertion tool,conical connection,narrow platform30Long motor insertion tool,conical connection,wide platform36CT-WLR10CT-NSR104235363738Long ratchet insertion tool,conical connection,wide platformShort ratchet insertion tool,conical connection,narrow platform433137CT-SLI10CT-WSI10Long motor insertion tool,conical connection,standard platform32Short motor insertion tool,conical connection,wide platform38CT-SLR10CT-WSR10Long ratchet insertion tool,conical connection,standard platformV3 INSERTION TOOLS19CT-NLM30CT-SLM30V3 long motor insertion tool,narrow platformCT-NLR3021V3 short ratchet insertion tool,narrow platformMT-DE001V3 short motor insertion tool,standard platform26CT-NSR30Int. connection abutmentextractorCT-SSM30V3 short motor insertion tool,narrow platform22MT-RE1724125CT-SSR30Drill extender42MT-RDL30V3 short ratchet insertion tool,standard platformImplant site depth probe4540V3 long ratchet insertion tool,standard platformCT-NSM30MT-BTI20Int. connection abutmentextractor, narrow platformCT-SLR30V3 long ratchet insertion tool,narrow platform44MT-RE160V3 long motor insertion tool,standard platform2420SURGICAL TOOLS3923Short ratchet insertion tool,conical connection,wide platformLong driver for 0.05 inch hex.43MT-RDS30Short driver for 0.05 inch hex.MT-RT070Surgical torque ratchet

18INSERTIONTOOLSC1 implant placement tools are specially designed tofacilitate quick and reliable implant procedures.Short motorinsertion toolLong motorinsertion toolShort ratchetinsertion toolLong ratchetinsertion tool

191Insertion options:1Manual insertion2Motor insertion3Ratchet insertion23Please note: In order to assure their efficientoperation, tools should be fully insertedinto the implants. A complete insertionof the tool optimizes the transfer of forceduring implant placement and enablessimple release of the tool from the hex.whenever necessary.Tool will not hold implant unless it iscompletely inserted into the connection.

20SURFACEQUALITYAll MIS implants undergo the same surfacetreatments; sand-blasting and acid-etching. Theresearch study was done on the SEVEN implant,however the results are valid for all MIS implantsurfaces.Identification Card and Codification of the Chemical and MorphologicalCharacteristics of 62 Dental Implant Surfaces. Part 3: Sand-Blasted/Acid-Etched (SLA Type) and Related Surfaces (Group 2A, mainsubtractive process).Background and ObjectivesMaterials and MethodsDental implants are commonly used indental therapeutics, but dental practitionersonly have limited information about thecharacteristics of the implant materialsthey take the responsibility to place in theirpatients. The objective of this work is todescribe the chemical and morphologicalcharacteristics of 62 implant surfacesavailable on the market and establish theirrespective Identification (ID) Card, followingthe Implant Surface Identification Standard(ISIS). In this third part, surfaces producedthrough the main subtractive process(sand-blasting/acid-etching, SLA-typeand related) were investigated.Eighteen different implant surfaceswere characterized: Straumann SLA (ITIStraumann, Basel, Switzerland), Ankylos(Dentsply Friadent, Mannheim, Germany),Xive S (Dentsply Friadent, Mannheim,Germany), Frialit (Dentsply Friadent,Mannheim, Germany), Promote (Camlog,Basel, Switzerland), Dentium Superline(Dentium Co., Seoul, Korea), Osstem SA(Osstem implant Co., Busan, Korea), Genesio(GC Corporation, Tokyo, Japan), Aadva (GCCorporation, Tokyo, Japan), MIS Seven (MISImplants Technologies, Bar Lev, Israel),ActivFluor (Blue Sky Bio, Grayslake, IL,USA), Tekka SA2 (Tekka, Brignais, France),Twinkon Ref (Tekka, Brignais, France),Bredent OCS blueSKY (Bredent Medical,Senden, Germany), Magitech MS2010(Magitech M2I, Levallois-Perret, France),EVL Plus (SERF, Decines, France), AlphaBio (Alpha Bio Tec Ltd, Petach Tikva, Israel),Neoporos (Neodent, Curitiba, Brazil). Threesamples of each implant were analyzed.Superficial chemical compositionwas analyzed using XPS/ESCA (X-RayPhotoelectron Spectroscopy/ElectronSpectroscopy for Chemical Analysis) andthe 100nm in-depth profile was establishedusing Auger Electron Spectroscopy (AES).The microtopography was quantified usingoptical profilometry (OP). The general

morphology and the nanotopographywere evaluated using a Field EmissionScanning Electron Microscope (FESEM). Finally, the characterization codeof each surface was established usingthe ISIS, and the main characteristicsof each surface were summarized ina reader-friendly ID card.ResultsFrom a chemical standpoint, in the18 different surfaces of this group,11 were based on a commerciallypure titanium (grade 2 or 4) and7 on a titanium-aluminium alloy(grade 5 or grade 23 ELI titanium). 4surfaces presented some chemicalimpregnation of the titanium core,and 5 surfaces were covered withresidual alumina blasting particles.15 surfaces presented differentdegrees of inorganic pollutions,and 2 presented a severe organicpollution overcoat. Only 3 surfacespresented no pollution (and also nochemical modification at all): GCAadva, Genesio, MIS SEVEN . From amorphological standpoint, all surfaceswere microrough, with differentmicrotopographical aspects andvalues. All surfaces were nanosmooth,and therefore presented no significantand repetitive nanostructures. 14surfaces were homogeneous and 4heterogeneous. None of them wasfractal.Discussion and ConclusionThe ISIS systematic approach allowedto gather the main characteristicsof these commercially availableproducts in a clear and accurate IDcard. The SLA-type surfaces havespecific morphological characteristics(microrough, nanosmooth, with rareand in general accidental chemicalmodification) and are the most frequentsurfaces used in the industry. Howeverthey present different designs, andpollutions are often detected (withblasting/etching residues particularly).Users should be aware of thesespecificities if they decide to usethese products.Identification card of the MIS SEVEN surface, following the Implant Surface Identification Standard (ISIS) codificationFig. 1Identification Card of the MIS SEVEN surface: MIS Seven (MIS Implants Technologies, Bar Lev, Israel; Figure 1) was a sandblasted/acid-etched surface on a grade 23ELI (Extra Low Interstitials) titanium core. No pollution or chemical modification was detected. the surface was moderately microrough, nanosmooth, and homogeneousall over the implant.LoB5 unit, Research Center for Biomineralization Disorders, Chonnam National University, South Korea. 2Department of Stomatology, School of Dental Medicine, Universityof Geneva, Switzerland. 3Department of Oral Surgery, Faculty of Medicine, University Federico II of Naples, Italy. 4Private Practice, Turin, Italy. 5Department of Physics, SeoulNational University, Seoul, South Korea. 6Private Practice, Paris, France. 7Private Practice, Ra’anana, Israel. 8Department of Periodontology and Implant Dentistry, Collegeof Dentistry, New York University, New York, USA. 9Private Practice, Reims, France. 10 Department of Oral and Maxillofacial Surgery, School of Dentistry, Chonnam NationalUniversity, South Korea. 11Department of Stomatology, Shanghai Sixth People’s Hospital, Shanghai Jiao Tong University, China. 12 Department of Periodontology and OralImplantology, University of Guarulhos, Sao Paulo, Brazil. 13 Department of Periodontics and Oral Medicine, School of Dentistry, University of Michigan, Ann Arbor, USA.*Corresponding author: David M. Dohan Ehrenfest.121

22PACKAGINGEach C1 implant comes with a sterile cover screw anda single-use final drill, suitable for all drilling protocols.Outer TubeInner TubeFinal DrillImplantTemporary CylinderCover ScrewThe sterile inner tube is fitted with a special titaniumsleeve that has an anti-rotation grip, to ensure easyengagement between the insertion tool and the implant

23Providing a simple, immediate identificationof implant type, length and diameter, the C1package is well-designed for ease-of-useduring surgical procedures.Implant diameter & platform indicationThe outer tube is color-coded, indicating the implantplatform. The numeric indication specifies implantdiameter and length.Prosthetic platform indicationProsthetic components are marked by specificcolors, representing platform diameters.Implant identification markingsQuick identification of implant size and length.Sticker on the box lid, specifies implantdiameter, length and platform size.Easy pull tabThe convenient pull tab facilitates quick and easyopening during surgery.

24PROSTHETICOPTIONSTissue LevelBone LevelHealing capTemporary cylinderCementing post

25Consistent, Concave Abutment ProfileConsistent, concave emergence profile abutments which, as scientificresearch has proven, when combined with platform switching, mayincrease soft tissue volume.CPKAngulated cementable abutmentMulti-Unit

26TISSUE-LEVELSCREW-RETAINEDSOLUTIONThe MIS CONNECT is a stay-in abutment system which enablesavoiding interference with the peri-implant gingival seal.It offers doctors the ability to maximize the tissue-level restorationconcept, enabling the entire prosthetic procedure and restorationto occur far from the bone, and at any level of the connective tissue.The CONNECT is designed to reduce micro-movements andmicro-leakage of bacteria at the bone level.Learn more about the CONNECTSystem on MIS websiteScrew-retainedprostheticsBone LevelMucosalheightsMIS CONNECTabutment

IT’S SIMPLEWHEN YOUHAVE ALL THEOPTIONSTHE CONNECTION FOR PREDICTABLE BIOLOGY. MAKE IT SIMPLEThe MIS C1 conical connection implant system offers uncompromising accuracy, with high initial and biologicalstability and a safe, yet simple, procedure. A consistent concave emergence profile of the C1 prosthetic componentsimproves soft tissue esthetic results. Learn more about the C1 implant and MIS at: www.mis-implants.com

MC-CONEN Rev.17www.mis-implants.com

Implant Cover Screw and Healing Caps Technical Information Material: Titanium Alloy Ti 6Al 4V ELI Sand-Blasted and Acid-Etched 3. 15 3.15 Ø3.75. 12 Ø4.20mm Implant Procedure Drilling Speed (RPM) 1200- 1500 900- 1200 500- 700 400- 700 200- 400 15-25 Diameter Ø1.90 Ø2.40 Ø2.40 Ø3 Ø3.50 Ø3.50 Ø3.50 Ø4 Ø4.20 Drilling Speed (RPM)