UNIVERSE Catalogue...2 UNIVERSE Best performance in the cases: • any bone density • post...
Transcript of UNIVERSE Catalogue...2 UNIVERSE Best performance in the cases: • any bone density • post...
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UNIVERSECatalogue
ed. 2019_1
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UNIVERSEwhere union is strength
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CERTIFICATIONSCertifications 1
UNIVERSE SYSTEMImplantBody 3SLsurfacetreatment 4Decontamination 5Implantneck 6Taperinternalconnection 6
SURGICAL KITCDandTDsurgicalKit 9Tools 10
SURGICAL PLANNINGSurgicalPlanning 13Preparation(Cylindricaldrillsurgicalprotocol) 14CDSurgicalProtocol 15Preparation(Tapereddrillsurgicalprotocol) 16TDSurgicalProtocol 17
PROSTHETIC PLANNINGCAD/CAMandFLEXATOR 19Impressiontaking 20Labcomponents 21Restoration 22Prostheticparts 23MUA 30
CONTENTS
PACKAGINGPackaging 37
ABOUT USAboutus 38Men,materialsandmachines 39Mechanicalexcellence 39Qualitychecks 40
Generalsaleterms 41Scientificbibliography 42Contacts 43
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11UNIVERSE |
Certificazioni
QualityMaintenanceisIML’sguidingprincipleinalifetimeproject embodied in the IML Production Protocol, aconstantly evolving tool applied to the daily productionofeachcomponent.IMLSAproductsaremarkedMedicalDevices:
•FDA 510 (k) approvedIMLSA’sQualityManagementforthedesign,manufacture,and marketing of dental implants, instrumentation, andrelated accessories complies with the Directives andregulationsinforce.
•EC (Class I) and EC 0425 (Class IIb and Class IIa),manufacturedinaccordancewithMedicalDevicesDirective93/42/EEC and subsequent modifi cation, amendments,andsupplements.
•[ICIM]UNI-ENISO9001:2015UNICEIENISO13485:2012
CERTIFICATIONS
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22 | UNIVERSE
Bestperformanceinthecases:
• any bone density• post extraction• delayed loading• immediate loading
UNIVERSE SYSTEM
Singleplatformforalldiameters
Micro-groovedCollar
SwitchingPlatform
Alternatingdoublespiral,square,andspur
Internalconnectionlockingthetapertotheinternaldodecagonusingapassingscrew
PassingscrewlockedbyaMorsetaperconnection
Self-tappingscrewtip
SLSurfaceTreatment
ConnectioninterfaceuptoH5.5mm
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33UNIVERSE |
Universe,withitsparticularconicalshape,offerssignificantbenefitsforawidespectrumofclinicalapplicationsalwaysprovidinggoodaestheticresults.
The implant features a highly innovative and ergonomicthreaddesign.This special morphology, due to the combination tothe spiral squared and spiral buttress threads, is able toincrease the implant surface by 20% compared to a thesameimplantwithoutbuttressthreadsprovidingagreaterand more uniform area of contact between bone andimplantspeedinguptheosteointegrationprocess.The alternate buttress and square double spiralloop generates a perfect balance between intrusive,compressive, and diverging forces capable of providingthebonewithexceptionalgrowthstimuli.Thestrongthreadsaredesignedfortheaddedcompressionandsurfacearearequiredinsoftboneplacementinorderto fill void spaces around the threads by ensuring animmediateprimarystability.
Indeed,Universe,showsexceptionalself-drillingpropertieswhichfacilitatetheimplantplacementandthedirectioninD1andD2bonetypes.
Universestandsoutforitsexcellentapicalpartdesignself-drillingandself-tapping.
Bestperformanceinthecases:• any bone density• post extraction• delayed loading• immediate loading
Implant Body
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44 | UNIVERSE
SL surface treatment
The IML Research and Developmentteam, in partnership with prestigiouschemistry laboratories which specialise inimplantology,hasformulatedtheoptimumsurfacetreatmentfortheirimplants:theSLtreatment.The performance monitoring has beenentrusted to the Polytechnic of Turinand to the University of Turin, which alsoperiodicallycheckproductionlots.IMLSLtreatmentistechnicallycomparableto the best SLA® treatments, the mostdocumentedintheliterature,anditiscarriedout using a sand-blasting technique, withdifferentgrainsizes,followedbyetchingofthesurfaceusingacidsolutions.The resulting surface has an appropriatestructure for anchoring osteoblasts andpromotesgood integrationof the implantwith the bone tissue. In fact, this type oftreatment suits any type of bone thanksto its ability to increase primary stabilityeven in the presence of atrophic sites orcompromisedbiologicaltissue.
Cell adhesion and roughness: laboratoryanalysisonIMLSLtreatedimplants
Aware of the key role played by thesurface treatment in determining thespeed and quality of osseointegration ofadental implant, IMLhasalways investedconsiderable resources in designingsurfaces that facilitate the cell adhesion.The tests carried out by the University ofTurin on implants with IML SL treatmentconfirmtheeffectivenessofthetopography
andofthesurfacechemistrydevelopedbytheIMLResearchandDevelopmentteam.According to reports of the University ofTurin and in accordance with protocolsof the international literature, 24 hoursafter cell seeding on Universe SL treatedimplants, it is possible to appreciate theuniformity of the growth and of the celladhesionovertheentireimplantsurface.Furthermore, observing by microscopethe nuclei (marked in blue) and thecytoskeleton (marked in red), it is evidentthatafter24hoursthecellsnotonlyhaveaverybranchedgrowth,with longfilopodiaand a complexmorphology, but they arealso multiplying in number. These are allindicatorsof thecellularbehaviourontheIMLSLtreatedsurface.(Pic1)
Another fundamental factor, determinedby the surface treatment and constantlymonitored by laboratory analysis, isthe roughness, that is the result of theunevennessonthesurface.During the surface analysis on Universeimplants, the CNR (National ResearchCouncil) of Turin examines the averageroughness(Ra/Sa),theSkewnessparameter(Rsk/Ssk), representing the prevalentsymmetry,andtheKurtosisparameter(Rku/Sku),representingtheindentationdensity.The resulting values, in relation to theinternational literature, confirm that theIML SL treated surfaces have an optimalroughness, homogeneously distributed.(Pic2)
Pic1.Detailsofthecellularmicrostructure-branchedanddendritic,withlongfilopodiaandcomplexmorphology-ofanIMLSLtreatedimplant.
Pic2.DetailsunderthemicroscopeofthesurfaceofanIMLSLtreatedimplant.
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55UNIVERSE |
Decontamination
Eventhedecontaminationprocessusedfor IMLimplantswas developed in collaboration with the Research andDevelopment team of our prestigious Italian universitiespartners.
This is a two-stage process, the second stage beingcomposed of passing the implants through a plasmareactor.The“PLASMAREACTOR”projectaimedtobuildamachinewithsuitablecharacteristics fortreatingdentalimplantsandtodefinetheoptimaloperatingprocedureandwasconductedincloseco-operationwiththeDepartmentof Applied Science and Technology of the PolytechnicUniversityofTurinandtheDepartmentofSurgicalSciencesattheUniversityofTurin’sCIRDentalSchool.
Phase1• Objective: inorganic waste removal, mechanicalmachining,andsurfacetreatmentsleaveresiduessuchascarbon and aluminium, universally considered possiblecausesofimplantsfailingtoosteointegrate;•Procedure:liquidsolutiontreatment;
Phase2• Objective: organic contamination removal, such asremovalofpro-inflammatoryagents;•Procedure:treatmentusinggascleaningagentsappliedviaanelectro-chemicalprocessperformed in theplasmareactor.
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The collar, which has microgrooves, ends witha smooth switching platform that becomesmore prominent as the diameter of the implant.It provides bone maintenance ensuring costantgingivaaestheticimpact.
Advantages:
•Increasedbonedistanceintheconnectionbetweenabutmentandimplant,thepointwherethebacterialloadattaches•Reductionofinflammatoryphenomena•Betterperi-implanttissuepreservation•Bettermaintenanceofcrestalbonelevel
Implant neck Taper internal connection
Atrue“coldwelding”inthetaperImplant-abutmentconnectionis produced by contact pressure between the surface of thefemale cone of the implant and that of themale cone of theabutment.Thefrictioncreatedbetweenthetwosurfacesofequalconicitytightenedto35Ncmgeneratesdirect,durable,andwaterproofinterlocking.Infact,thistypeofconnectionistheonlyonethatapproachestheidealconditionofamonoblockimplant,whichistheoneusedinthemonophasicsystem,universallyproventobelonger-lastingthanbiphasicsystems.However, being able tomechanically achieve a perfectMorsetapered connection requires great attention and special skillsstartingfromthedesignstage.IML’sdesignersandmechanicsknowhowtodetectandevaluateeachcriticalpointinordertoproduceperfectcomponentswhoseconnectionnotonlyworkswellduringtheprojectbutespeciallyalsointhepatient’smouththroughouttheirlife.As demonstratedby numerous studies carried out around theworld,theresultingsystemiseffectiveandreliable.(Bibliographypage42,rif.1)
Advantages:
•Eliminationofthepassageoffluidsandsobacterialcolonization•Eliminationofmicromovementsattheinterfacebetweenthecomponentsresultingingreatermechanicalstability•Lowincidenceofclinicalcomplications•Reductionofperi-implantinfections•Significantreductioninimplantfailures
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77UNIVERSE |
TheUniverseimplanthastheadvantageofalockingtaperconnectionwithapassingscrewwhichachievesapreciseandfunctionallyperfectfitwhencoupledwithadoubleinternalhexagon.Adesignchoicefacilitatingproceduresduringthesurgicalphase.
•Perfectantibacterialseal•12PossibleAbutmentPositionings
Thedecisivefactorinachievingcompletesystemstabilityistodeterminethefunctionofthepassingscrew,whichmustguaranteetheimplant-abutmentconnection.Thisworkisnoteasyasthescrewisrepeatedlysubjecttovibrationfatiguewhichnaturallytendstocausetheunscrewingofthescrewfromitsseat.HerethesolutionidentifiedbyIMListhetaperconnectionofthescrewheadinsidetheabutment.
TheUniverseimplantconnectionisnotonlydesignedtoguarantee correct implementationof thebenefitsofalockingtaperconnectionbutalsothoseofa“onepiece”implant.Inviewofthestudiesthatidentifytheconcentrationofmechanicalstressincorticalareasasapossiblecauseofboneresorption(Bibliographypage42,rif.2),theIML engineers have designed the Universe implantwith an internal geometry thatmakes it possible forthe implant-abutment-screwsystem tobehave likeasingleone-pieceimplantsystem.IndeedtheUniverseimplant-abutment-screwconnectionhasatotalheightuptoabout5.5mm.Thebenefitofthisisbetterdistributionoftheloadandthelevers,whichspread80%oftheforcethroughoutthesysteminsteadofonlycentringthemonthecorticalareaasisfrequentlythecaseinotherimplantsystems.(Bibliographypage42,rif.3)
Load50NσvonMises=28.23N/mm2 Load150NσvonMises=84.86N/mm2 Load250Nσ vonMises=140.75N/mm2 Load500Nσ vonMises=273.97N/mm2
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88 | UNIVERSE
SURGICAL KITS
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99UNIVERSE |
THIS DESIGN IS THE PROPER T Y OF THE IPPI SRL. IT IS PROHIBITED TO COPY OR REPRODUCE UNAUTHORIZED OF THIS DOCUMENT OR ANY PAR T THEREOF, ALL RIGHTS ARE RESER VED.
QUESTO DISEGNO È DI PROPRIE TÀ DELLA IPPI SRL. È VIE TATA LA COPIA E LA RIPRODUZIONE NON AUTORIZZATE DI QUESTO DOCUMENTO O PAR TE DI ESSO, TUT TI I DIRIT TI SONO RISER VATI .
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L_871_1016_00_00 1/1
Ponzilacqua NicoDATA : 10 10 2019
Parte 01 Vassoio: RADEL R 5100NT15 BIANCO Parte 02 Fondo: RADEL R 5100NT15 BIANCO
Parte 03 Coperchio: RADEL R 5000CL301
00
Layout di stampa olv VisictyNUMERO DI DISEGNO / DRAWING NUMBER FOGLI / SHEETS SCALA / SCALE
1:1FORMATO / SIZE
A2
DESCRIZIONE / DESCRIPTION REDATTO DA / EDITED BY
MATERIALE / MATERIAL MASTER
MODIFICHE / MODIFICATIONS
REV
REVISIONI /REVISION
DATA REVISIONI /DATE REVISION
TOLLERANZE GENERALI / GENERAL TOLLERANCE
UNI EN 22768 - m ISO 2768 - mUNI EN 22768 - K ISO 2768 - K
APPROVATO DA / APPROVED BY
firma / signature
IPPI SRLvia Brodolini 22, 24, 26
Loc. Crespellano40053 Valsamoggia (BO)
tel. +39 051969510fax +39 0516720648p. iva 00305440372MAIL: [email protected]
BOZZA rev. DRAFT rev. 03
SILICON PARTS COLORS
AZZURRO/LIGHT BLUE : PANTONE 290
BIANCO/WHITE : RAL 9010
BLU/BLUE : RAL 5015
GIALLO/YELLOW : RAL1016
GRIGIO/GREY : RAL7040
MARRONE/BROWN : RAL8024
ROSSO/RED : RAL3020
VERDE/GREEN : RAL6032
ARANCIONE/ORANGE : RAL2003
VIOLA/PURPLE : PANTONE 265
NERO/BLACK
FUCHSIA : RAL 4003
C
D
F
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B
= Ø 1,5mm
= Ø 2mm
= Ø 4mm
= Ø 5mm
= Ø 6mm
= Ø 7mmSILI
CON
SU
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RTS
SEPA
RATE
LY S
UPP
LIED
*
*
Piedini (opzionali), colore *Feet (optional), colors*
Piedini (opzionali), colore *Feet (optional), colors*
QR CODE URL :http://www.immediateload.com/UNCD191.pdf
Universe
Ø5-6pØ4-6p
A
GREY
A
GREY
A
GREY
A
GREY
A
GREY
A
GREY
A
GREY
A
GREY
A
GREY
A
RED
A
RED
A
RED
A
RED
A
RED
A
RED
A
RED
A
RED
Ø7
Ø7
RED
E
RED
E
Implant DriversDrivers Ex.1,26
H10 H15H10 H15 H10 H15
Guide Pin
Extractor Mua
Precision Ø2 Ø2.7 Ø3.1 Ø3.6 Ø3.9 Ø4.4 Ø4.9DrillExtension
Drill Stop Ø2 - Ø2.7 - Ø3.1 - Ø3.6 - Ø3.9 Drill Stop Ø4.4 - Ø4.9
Ed. 2020-00
PANTONE 428 C
UniverseCYLINDRICAL DRILL PROTOCOL
42.0
TherearetwosurgicalkitoftheUNIVERSEimplantsystem:CD(cylindricaldrillsurgicalprotocol)andTD(tapereddrillsurgicalprotocol).Surgicalboxesaredesignedformaximumsimplicilityofuseandmadeentirelyofplasticmaterialssuitableforsteamsterilisation.Theinstrumentpositionsareclearlylabelledinordertofacilitateidentificationduringthesurgicaloperationandtocorrectlyreplacethemafterthemaintenanceprocedure.Thesiliconsupportssecuretheinstrumentsfirmlyduringtransportationandsterilisation.
Thekitcontainsstopsthatallowdrillstobeusedsafelyandtheyaresuppyseparately.Cylindricaldrillsandpilotdrillsaremarkedwithindicatorsreferringtoimplantheightanddrillstops.
AllIMLsurgicalinstrumentsaremanufacturedinSurgicalSteelofthehighestqualitythatoffersthebestperformanceintermsofwearresistanceandtorque.Tofollowcarefullythedirectionsofthesurgicalandprostheticprotocolandtheinstructionsforcleaningandmaintenanceoftheproductsensurestheoptimallong-termperformanceandreliabilityforwhichproductsweredesigned.
Usingasmartphone,theQRcodeprintedontheboxallowstodisplaythesurgicalprotocolanddownloaditfromimmediateload.com
CD surgical kit TD surgical kit
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1010 | UNIVERSE
Tools
UniverseCDbox for surgicalinstruments
BOX-UNCD
Universe TDbox for surgicalinstruments
BOX-UNTD
Precisiondrill
U
0.5 SFYS18ø
H
CylindricalpilotdrillforUniverseCD
2.0 SFYS19
DrillØ
CylindricalpilotdrillforUniverseTD
2.0 FL30-UøDrill
Drillstopskitforpilotdrill(6pcs)forUniverseTD
STF-KIT
Drillextension
PR-FR
Guidepin
UN-PIN
Conicaldrill
6 8 10 11.5 13 15
3.4 FC34-6 FC34-8 FC34-10 FC34-11.5 FC34-13 FC34-15
4 FC40-6 FC40-8 FC40-10 FC40-11.5 FC40-13 FC40-15
4.5 FC45-6 FC45-8 FC45-10 FC45-11.5 FC45-13 FC45-15
5 FC50-6 FC50-8 FC50-10 FC50-11.5 FC50-13 FC50-15
Implantø
ImplantH
FC34-6isdesignedforimplantØ4h6
ReddrillstopskitfordrillsfromØ2toØ4forUniverseCD
SFYS042
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1111UNIVERSE |
GreendrillstopskitfordrillsfromØ4.4forUniverseCD
SFYS043
Cylindricaldrill
2.7 SFYS21
3.1 SFYS22
3.6 SFYS23
3.9 SFYS20
4.4 SFYS25
4.9 SFYS55
Implantdriverformotor
10 15
AVM-C AVM-L
H
Multitoolimplantdriver
10 15 25
CCIB-10 CCIB-15 CCIB-25
H
Tools
Dynamometricratchet
DN-I
Torquerange:15-45Ncm
Fixedratchet
CR-U
Multitooldriverforscrews
10 15
CCIV-10 CCIV-15
H
Digital adapter for multitooldriver
SFYS051
Motordriverforscrews
6 12 17
SFYS011 SFYS012 SFYS013
H
Smartpegforimplant
SM-PEG
Multitoolremoverforabutment
IMESTR-U1
MultitooldriverforstraightMUA
AMM-U
MotordriverforstraightMUA
SFYS016
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1212 | UNIVERSE
SURGICAL PLANNING
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1313UNIVERSE |
A B C D E F G H
CODEIMPLANTMEASURE(ØxH)
COREØATTIP
THREADØATTIP
IMPLANTØINTERFACE
ØTHREADPITCH
SURFACETREATMENT
H
SWITCHINGPLATFORMH
IMPLANT H
IM34-8 3.4X8 1.35 2.75 3.7 3.3 1.2 7.8 0.2 8
IM34-10 3.4X10 1.35 2.75 3.7 3.3 1.2 9.8 0.2 10
IM34-11.5
3.4X11.5 1.35 2.75 3.7 3.3 1.2 11.3 0.2 11.5
IM34-13 3.4X13 1.35 2.75 3.7 3.3 1.2 12.8 0.2 13
IM34-15 3.4X15 1.35 2.75 3.7 3.3 1.2 14.8 0.2 15
IM40-6 4X6 1.95 2.9 4 3.6 1.2 6.1 0.9 7
IM40-8 4X8 1.45 3.15 4 3.6 1.2 7.8 0.2 8
IM40-10 4X10 1.45 3.15 4 3.6 1.2 9.8 0.2 10
IM40-11.5 4X11.5 1.45 3.15 4 3.6 1.2 11.3 0.2 11.5
IM40-13 4X13 1.45 3.15 4 3.6 1.2 12.8 0.2 13
IM40-15 4X15 1.45 3.15 4 3.6 1.2 14.8 0.2 15
IM45-6 4.5X6 1.8 3.45 4.5 3.9 1.2 6.1 0.9 7
IM45-8 4.5X8 1.8 3.45 4.5 3.9 1.2 7.8 0.2 8
IM45-10 4.5X10 1.8 3.45 4.5 3.9 1.2 9.8 0.2 10
IM45-11.5
4.5X11.5 1.8 3.45 4.5 3.9 1.2 11.3 0.2 11.5
IM45-13 4.5X13 1.8 3.45 4.5 3.9 1.2 12.8 0.2 13
IM45-15 4.5X15 1.8 3.45 4.5 3.9 1.2 14.8 0.2 15
IM50-6 5X6 2.2 3.8 5 4.2 1.3 6.1 0.9 7
IM50-8 5X8 2.2 3.8 5 4.2 1.3 7.8 0.2 8
IM50-10 5X10 2.2 3.8 5 4.2 1.3 9.8 0.2 10
IM50-11.5 5X11.5 2.2 3.8 5 4.2 1.3 11.3 0.2 11.5
IM50-13 5X13 2.2 3.8 5 4.2 1.3 12.8 0.2 13
IM50-15 5X15 2.2 3.8 5 4.2 1.3 14.8 0.2 15
Ø 2,882,2
Surgical Planning
UNITOFMEASUREMENT:mm
Coverscrewincluded
OPTIONAL:Thecoverscrewforboneringcanbepurchasedseparately
E
D
G
FH
A
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C
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1414 | UNIVERSE
Preparation (Cylindrical drill surgical protocol)
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1515UNIVERSE |
CD Surgical Protocol
TheUniverseCDSurgicalProtocolhasbeendevelopedtoprovidesurgeonswithindicationsonhowtochoosethemostsuitableinstrumentsforimplantsitepreparation,dependingonthetypeofbone.However,itisthedutyofthesurgeontoapplythemostappropriatesurgicalprotocol on the basis of his/her experience and following a thoroughassessmentoftheclinicalsituationoftheindividualpatient.Forthepreparationoftheimplantsite,IMLhasdevelopedcylindricaldrillswithataperedtipanddepthmarks inaccordancewiththelengthoftheimplant;theycanbeusedwithdrillstops.IncaseofdenseD1bone,adequatecorticalbonepreparationisessentialinordertoallowtheimplanttobeinsertedsmoothlyinthebone.
IMPORTANT:-Drillspreparethesite0.7mmmorethantheheightoftheimplant.-Theimplantissuppliedcompletewithcoverscrew-Recommendedtorquemax:45Ncm
Fig.exampleofCDdrillingsequenceindenseboneofimplantØ3.4h10
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1616 | UNIVERSE
Preparation (Tapered drill surgical protocol)
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1717UNIVERSE |
TD Surgical Protocol
The Universe TD Surgical Protocol has been developed to provide thesurgeonwiththemostappropriatetoolsforbonecompliance,andisalsosimpleandpractical.ThepreparationoftheimplantsitefortheUniverseimplantiscompletedin3simplesteps,afterwhichtheimplantcanbeinsertedeasily:
The preparation of the implant site is performed by tapered drills thatoptimisetheboneavailabletoplacetheimplant,withoutwaste.Thesedrillsaresizedatthecoreofeachsinglediameterandheightoftheimplanttofacilitatethedrillingprotocolreducingittothreesimplesteps.Theparticulartipshapeguidestheprogressiveadvancement,respectingtheboneandpreparingacustomizedsite.However, it is thedutyofthesurgeontochoosethemostappropriatesurgicalprotocolbasedonhisorherexperiencefollowingathoroughassessmentoftheindividualpatient’sclinicalsituation.
IMPORTANT:-Drillspreparethesite0.3mmmorethantheheightoftheimplant.-Theimplantissuppliedcompletewithcoverscrew-Recommendedtorquemax:45Ncm
1° step 2° step 3° step
Implant Ø5
Implant Ø4.5
Implant Ø4
Implant Ø3.4
Precision drill Pilot drill Ø2 Drill Ø3.4
Precision drill Pilot drill Ø2 Drill Ø4.0
Precision drill Pilot drill Ø2 Drill Ø4.5
Precision drill Pilot drill Ø2 Drill Ø5.0
Fig.exampleofTDdrillingsequenceofimplantØ4h10
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1818 | UNIVERSE
PROSTHETIC PLANNING
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1919UNIVERSE |
COMING SOON2020
NEW PACKAGING
CAD/CAM
FLEXATOR
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2020 | UNIVERSE
Impression taking
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2121UNIVERSE |
Lab components
Opentrayimpressioncoping(*)
U TRA-Uø
Slimopentrayimpressioncoping(*)
U TRA-SLø
Bridgeopentrayimpressioncoping(*)
U TRA-Pø
Closedtrayimpressioncoping(*)
U TRA-Cø
(*)Specificscrewforimpressioncopingincluded.
Tear-offclosedtrayimpressioncoping
U TRA-Sø
Implantreplica
U ANI-Uø
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2222 | UNIVERSE
Restoration
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2323UNIVERSE |
Prosthetic parts
Healingscrew
1 2 3 4 5
U MGIU-1 MGIU-2 MGIU-3 MGIU-4 MGIU-5
H
Ø
Shifthealingscrew
1 2 3
U MGIU-21 MGIU-22 MGIU-23
H
Ø
Slimhealingscrew
U MGIU-0Ø
Bridgepeekhealingscrew(**)
U MGIU-99Ø
(**)Connectingscrewforpeekandtemporaryabutmentincluded.
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2424 | UNIVERSE
Prosthetic parts
(**)Connectingscrewforpeekandtemporaryabutmentincluded.
Peektemporarystraightabutment(**)
0
U MDIU-100
H
Ø
15°angledpeektemporaryabutment(**)
0
U MIU15-100
H
Ø
Temporarystraightabutment(**)
0
U MDIU-101
H
Ø
SpareConnectingscrewforpeekandtemporaryabutment
VT-K
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2525UNIVERSE |
Straightabutment(*)
0
U MDIU-0
H
Ø
Aestheticstraightabutment(*)
1 2 3 4
U MDIU-1 MDIU-2 MDIU-3 MDIU-4ø
H
Shiftaestheticstraightabutment(*)
1 2 3
U MDIU-21 MDIU-22 MDIU-23ø
H
Slimstraightabutment(*)
0
U MDIU-013
H
Ø
Prosthetic parts
(*)Connectingscrewabutmentincluded.
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2626 | UNIVERSE
TBaseabutment(*)
1 2
U MDIU-51 MDIU-52ø
H
RotatingTBaseabutment(*)
1 2
U MDIU-53 MDIU-54ø
H
Flattoflatstraightabutment(*)
U MDIU-99Ø
15°angledabutment(*)
0
U MIU15-0
H
Ø
(*)Connectingscrewabutmentincluded.
Prosthetic parts
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2727UNIVERSE |
Aesthetic15°angledabutment(*)
1 2 3
U MIU15-1 MIU15-2 MIU15-3ø
H
Aesthetic25°angledabutment(*)
1 2 3
U MIU25-1 MIU25-2 MIU25-3ø
H
Shiftaesthetic15°angledabutment(*)
1 2 3
U MIU15-21 MIU15-22 MIU15-23ø
H
Largeballabutment
1 2 3 4
U OTKIU-1 OTKIU-2 OTKIU-3 OTKIU-4ø
H
Prosthetic parts
(*)Connectingscrewabutmentincluded.
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2828 | UNIVERSE
Titaniumclosedcapforlargeball
4.1
SFYP062
H
Titaniumopencapforlargeball
2.6
SFYP063
H
Spare
O-ring(10pcs)
GOM-I
NonrotatingCr/Cobasecalcinableabutment(*)
1
U MDIU-70
H
Ø
Prosthetic parts
(*)Connectingscrewabutmentincluded.
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2929UNIVERSE |
Prosthetic parts
RotatingCr/Cobasecalcinableabutment(*)
1
U MDIU-71
H
Ø
Calcinablenonrotatingabutment(*)
2
U CALI-U
H
Ø
SpareConnectingscrewforabutment
VT-P
(*)Connectingscrewabutmentincluded.
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3030 | UNIVERSE
MUA positioning
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3131UNIVERSE |
MUA
StraightMUA
1 2 3
U CDIU-1 CDIU-2 CDIU-3
H
Ø
17°angledMUA(*)
3 4
U CIU17-3 CIU17-4
H
Ø
30°angledMUA(*)
3 4 5
U CIU30-3 CIU30-4 CIU30-5
H
Ø
(*)ConnectingscrewforangledMUAincluded.
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3232 | UNIVERSE
MUA impression taking
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3333UNIVERSE |
MUA open tray impressioncoping(*)
SFYP076
OPTIONAL:LongscrewforMUAimpressioncoping
20
SFYV011
H
MUAreplica
SFYP077
(*)ConnectingscrewH15forMUAimpressioncopingincluded.
MUA lab components
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3434 | UNIVERSE
MUA restoration
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3535UNIVERSE |
MUA prosthetic parts
MUAhealingcap(*)
SFYP075
MUApeektemporarycylinder(*)
SFYP101
MUAtitaniumcylinder(*)
SFYP078
MUACr/Cobasecalcinablecylinder(*)
SFYP100
MUAcalcinablecylinder(*)
SFYP079
Spare
M1.4connectingscrewforMUAprostheticparts
SFYP009
Max15Ncm
(*)M1.4connectingscrewforMUAprostheticpartsincluded.
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3636 | UNIVERSE
PACKAGING
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3737UNIVERSE |
UNIVERSE CONICAL IMPLANT Ø4.0 H10 UNIVERSE IMPIANTO CONICO Ø4.0 H10
IM40-10 008423
2024-05
0425
IML SA, via Moree,16 -6850 Mendrisio - (Switzerland)
LOT
Nameofproduct
Donotuseifpackagingis
damaged
Warning,pleasereadencloseddocuments
Diameter
Manufacturer Donotre-sterilize
Sterilizeddevice
Productcode
Single-usedevice
Lenght
Lotnumber
UsebyYYYY-MM
AllIML’sproductsareCEincompliancewiththeDirective93/42/CEE.
IML’spackagingprocessisperformedincompliancewiththestandardssetbytheEC93/42Directive,whichguaranteethesterilisationshelf-life.TheIMLimplantsaresterilisedbybetarays.Theimplantsarepackagedinavialthat,inturn,isplacedinsideaplasticcontainersafetysealcap.Thentheplasticcontainerisplacedinsideacardboardboxbearingaremovablelabel,bearingtheimplantinformationdetails.Furthertwocopiesofthelabelareintothecardboardbox,tobeplacedontheimplantpassportandonthepatient’smedicalrecordsheet.
ThemethacrylatevialwithPolyethylene(PE)topiscarefullywashedanddried
Thecardboardbox(3.5x6,2x3,5cm)mustbestoredinadryplaceatroomtemperature
ThetransparentPolyethyleneTerephthalate(PET)containerisclosedwithawhitePolypropylene(PP)stopperwithasafetyseal
Packaging
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3838 | UNIVERSE
ABOUT US
The Swiss company IML SA Swiss DentalImplants was founded in 2009 by a close-knit team of professionals with twenty-yearexperience in the dental industry, especiallydealingwithimplants.Itsengineerscontinuouslystrivetofindeffectivesolutionsfornewimplantologyneeds,onesthatmeettheexpectationsofthemostdemandingprofessionals.Main aim: to offer oral implantology that isSimple,SafeandStablethroughtime.These “3Ss” summarise the guidelines theCompanyhasestablishedforitsownstandardsandarepursuedineveryactionittakeseveryday.
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3939UNIVERSE |
Onlythebestrawmaterials,themostadvancedtechnology,andthebestprofessional.These secrets of IML guarantee excellent products, free frommanufacturingdefects.
•Super-skilledoperatorsabletodevelopaman-machinerelationshipabletooptimisethefeaturesoftheirtoolstoachievemaximumperformance•Topqualitytitaniumformedicaluse.grade4forimplantsandgrade5 forprostheses. IML titanium isexclusively imported fromtheUnitedStates,isguaranteedfreefrommanufacturingdefectsandradioactivity•Mechanicalproductionusinglatestgenerationslidingheadmachines
Men, materials and machines
How important is it for themechanical work in the connection of animplantorintheheadofascrewtobewell-executed?
Justasimportantasitisthattheabutmentremainswellscrewedtotheimplant.IMLisfullyawareoftheissuesgeneratedbyalltypesofproductiondefectsandknowshowtoresolvethem,andaboveall,itknowshowtoobtain,andsystematicallyrepeat,aPERFECTMECHANICALEXECUTION.Forexample,IMLguarantees5thousandthsofamillimetertoleranceonthemeasureofthehexagonalconnectionoftheimplent,oneverysingleimplant.
Mechanical excellence
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4040 | UNIVERSE
Controlofqualityorquality control?Aplayonwords,useful inexplainingthatcheckingisnotenoughforIML.ControlinIMLissynonymouswithuncompromisingeliminationofallthosecomponentsthatpresenttheslightestimperfectionevenifonlyaesthetic.It means making a commitment to selling only very specificcomponentsinordertobe“aspreciseastheSwiss”.ItmeansthatwemustfullytakeonthecostofthiscommitmentbothpursuedandmaintainedethicallyandproudlybyIMLandbytakingthepatient’shealthandthesurgeon’sskillsintoconsideration.
Process:
•Identificationofeachindividualcomponent’scriticalpoints
•Draftingdocumentswith a list of the critical points specific toeachindividualcomponentindicatingthesequenceofcheckstobecarriedout
• Over 30 checks are performed on 100% of the componentsmanufacturedinthevariousmanufacturingphases:-Dimensionalcontrols-Removalofburrsanddross-Functionalteststoremovenon-perfectcomponentsareperformedon100%ofthecomponents
•Theoperatorsignsoffeachchecktocertifythatheorsheacceptsresponsibilityforthechecksmade
•Regularlaboratoryanalysescheckconformityofimplantsurfaces
Quality checks
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4141UNIVERSE |
VALIDITYThiscatalogueisthe2019_1editionandreplacesanypreviouseditions.
EXCLUSIONOFRESPONSIBILITYThedentalimplantsmanufacturedbyIMLSA(hereinafteralso“IML”)andotherIMLmedicaldevicesmaybeusedonlywithoriginalIMLcomponentsandinstruments,followingtheinstructionsprovidedinsidethepackage.TheuseofdevicesmanufacturedbyothercompaniesormanufacturedbyIML,butnotbelongingtothesameimplantlineshallinvalidatethewarrantyandterminateanyexplicitorimplicitobligationofIML.Theclinicalprotocolsprovidethepractitionerwithareferenceguideandshallnotbeconstruedasanalternativetotheuser’strainingandprofessionalexperience.ThepractitionerusingIMLmedicaldevicesmustensurethatdevicebeingusedissuitedtothepatientandtoexistingcircumstances.IMLdoesnotacknowledgeanyexplicitorimplicitresponsibility,norshallithaveanyresponsibilityforanydirect,indirect,criminalorotherdamagederivingfromorassociatedwithanymistakesinprofessionaljudgements,inthepracticalapplicationorinsertionofIMLproducts.Thepractitionerisalsoundertheobligationtokeepup-to-dateatalltimeswiththemostrecentdevelopmentsandapplicationsofIMLmedicaldevices.Anydescriptionsoftheproducts,depictions,illustrationsincatalogues,illustrativeandsalesmaterials,pricelistsorotherinformativedocumentsissuedanddistributedbyIMLinanyformareprovidedonlyforexplicativepurposes.ThePurchaseracknowledgesthathe/shedoesnotpurchasetheproductsonthebasisofsuchdescriptionsand/orillustrations.
PRODUCTSMODIFICATIONSTheimagesoftheproductsshowninthecatalogues,andinallIMLpublications,areforillustrativepurposesonly.IMLreservestheright,atanytimeandatitssolediscretion,tomakechangestotheproducts,codesanddescriptionswithoutobligationofnotice.
COPYRIGHTANDTRADEMARKSProtectionofprivacypursuanttolaw.ItisstrictlyprohibitedtocopyorpublishalloranypartofthiscataloguewithoutthewrittenauthorisationofIMLinanypaperandelectronicform.
ORDERPLACEMENTIMLdentalimplantsandmedicaldevicescanbeorderedbyquotingtheproductcodeanddesiredquantity,inthefollowingways:
Telephone:0041(0)916001310Mon–Fri09:00-13:00/14:00-17:00,E-mail:[email protected]
PRODUCTSHIPMENTSExceptintheeventofforcemajeure,goodswillbeshippedtotheaddressindicatedbytheclientaccordingtothetermsindicatedbythesupplieratthetimeofacceptanceoftheorder.
RETURNEDMATERIALSTherighttohavepurchasedproductsreplacedmaybeexercisedwithin5workingdaysfromtheproductsdeliverydateandmustbepre-authorisedbyIMLinwriting.Therighttoreplacementshallbecancelledintheeventtheproductintegrity(packagingand/oritscontent)iscompromised.ForexampleinthecasesinwhichIMLobserves:-thatthepackagehasbeenopened-thatthepackagehasbeendamaged(evenifstillsealed)-thattheproducthasbeendamagedotherthanfortransportation.IfIMLdoesnotaccepttoreplacetheproduct,itwillreturnit,chargingshipmentcoststothePurchaser.
PRICESThevaluesindicatedintheofficialpricelistarenetofVAT,transportcostsandanybankchargesforpaymentcollection.Unlesspreviouslyagreedotherwise,priceschargedwillbetheonesindicatedintheofficialpricelistinforceatthetimeoftheorderacceptance.
CHANGESTOTHEPRODUCTSANDPRICESIMLreservestherighttomakechangestotheproductscontainedinthiscatalogueandtotheirpricesortodiscontinuetheirproductionatanytime,withouthavingtogivepriornotice.
APPLICABLELAWANDJURISDICTIONTheseSalesTermsshallbegovernedandinterpretedaccordingtoSwissCivilCodeandtheexclusiveplaceofjurisdictionshallbethecourtsofLugano.
General sale terms
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4242 | UNIVERSE
ConnessioneConometricaMorse-taperconnection•DiCarloF,MarincolaM,QuarantaA,BediniR,PecciR(2008)AnalisiMicroTacdiimpiantiaconnessioneconometrica.DentCadmos76(3):1-6.•BediniR,IoppoloP,PecciR,RizzoF,DiCarloF,QuarantaM(2007)Studioinvitrosullaconnessionedisistemiimplantaridentali.RapportiISTISAN07/7.•HermannJS,SchoolfieldJD,SchenkRK,BuserD,CochranDL(2001)Influenceofthesizeofthemicrogaponcrestalbonechangesaroundtitaniumimplants.Ahistometricevaluationofunloadednon-submergedimplantsinthecaninemandible.JPeriodontol72:1372-1383.•CrespiR,CappareP,GherloneE.Radiographicevaluationofmarginalbonelevelsaroundplatform-switchedandnon-platform-switchedimplantsusedinanimmediateloadingprotocol.IntJOralMaxillofacImplants2009.•DibartS,WarbingtonM,SuMF,SkobeZ(2005)Invitroevaluationoftheimplant-abutmentbacterialseal:thelockingtapersystem.IntJOralMaxillofacImplants20:732-737.•PerssonLG,LeckholmU,LeonhardtA,DahlenG,LindheJ(1996)BacterialcolonizationoninternalsurfacesofBranemarksystemimplantcomponents.ClinOralImplantsRes7:90-95.•HanssonS.Implant-AbutmentInterface:BiomechanicalstudyofFlatTopversusConical.2000:Biomechanics,departmentofpolymericmaterials,ChalmersUniversityofTechnologyGoteborg,Sweden.•DibartS.etal.Invitroevaluationfortheimplant-abutmentbacterialseal:ThelockingTapersystem.Int.J.OralMaxillo-facialImplants.2005;20:732-737.
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