Product Catalog RevE - Biomet 3i

1 ProductCatalog1 Instr uc tions For Us e:OSSEO TITE , OSSEO TITE XP , Cer tain , PR EVAIL , Encode , IO L , Miniplant ,Micr oM ini pl ant , GingiH ue , Gold-T ite , Provide , ST A , ZiR eal , CAMSt ruct SU RE , NanoT ite , PreFor mance , QuickBridge This documentappliesto dentalimplants, abutments,over denturebar s andassoci ated sur gical, restor ative and denta l labo rator y de tai led infor mationon the specificprocedurefor the productyou ar e using,please ref er to the individualproductlabelsand/orthe appropriatemanual:Produ ct Cat al og -CAT ALO G:Listingof al l productsSurgi cal Manual -CA TSM:Dental implantplacement,surgicalpro tocol and coverscrew inser ti onRest or ati ve Manual-CATR M:Abutmentplacement,provisionaland finalre stor ati on protocolsAddit ional Rest orativeManuals:CAM Str uctSURE Manual-ART868 DIEM Guidelines-ART860 EncodeRest orativeManual-ART924Qu ickBridgeManual-ART1016 Descript ion.

2 BIO MET3iDental Implantsar e manufacturedfrom biocompatibletit aniumand ti taniumalloy and abutmentsfrom titanium,titaniumalloy, goldalloy and cer amic mater ial. BIO MET3iDentalImplantsand Abutments includevari ous surf ace tr eatmentsand restorativecomponents aremanufactur ed with titanium,titaniumalloy, gold alloy, stainlesssteel and avari et y of polymer sp ecif ic pro duct descr iptionand net quantityrefer to individual pr oductla bels .Indi cat ions for Use:BIO MET3iDental Implants ar e intendedfor surgicalplacementin the upperor low er jaw to providea meansfor prostheticattachment in single tooth restor ationsand in partiallyor fully ed entulousspanswit h mul ti pl e si ngle teeth utilizingdelayedor immediateloading,or as a ter minalor int ermedi ar y abutmentfor fixed or removablebridgework and to retainov erd OM ET3iOSSEOTITEand NanoTiteDental Implantsare intendedfor immediatefuncti on on singletooth and/ormultipletooth applicationswhen good primarystabili ty is achieved.

3 With appropriate occlusalloading,in order to restorechewi ng functi ti onal Indications:BIO MET3iDental Abutmentsand Overdenture Bars ar eint endedfor use as an accessoryto endosseousdentalimplantsto support aprost heti c devi ce in a par tially or edentulous in tendedfor useto sup port si ngle and multipletooth pr ostheses,in the mandibleor pr osthesescan be scr ew or cement-retainedto the Abut men t Postsand Temporary Cy lindersare intendedfor use as anaccessory to en dosseousdentalimplantsto su pport a prostheticdevicein apa rt ia ll y or ful ly edentulouspa tient.

4 Theseare intendedfor use to supportsingleand mult ipl e unit prosthesesin the mandibleor maxillafor up to 180 days duringendosseousan d gingivalhealingand are for nonocclusalloadingof singleandmult ipl e unit provisionalrestor prosthesescan be scre w and/orcement-r etai ned to the Cylinders requir e aminimumint erar ch spaceof 6mm and a maximumangulationof 15 . Thesealsoallow for occlusal loadingof singleand multipleunit restorationsof integratedim plantsfor guidedsoft Qui ckBridgeProvisionalComponentsare intendedto be matedwith BIOMET3iConi cal Abut mentsfor use as an acces sory to endosseousdentalimplantstosuppor t a prost hetic devicein a partiallyor fully Bri dge Pr ovisionalComponentsare intendedto supportmu ltiple unitprost hesesin the mandibleor maxillafor up to 180 days duringendosseousandgingiv al heal raindicati on.

5 Placementof dentalimplantsmay be precludedby patientconditi ons that ar e contr aindicationsfor tal Implantsshouldnot be placed in patientswher e the remainingjaw bone is too diminishedto pr ovi de adeq uate orageand Handling:Devicesshouldbe sto red at room temperature. Refer toindividualproductlabelsand the Sur gical Manualfor specialstor age or handlingconditi nings:Excessivebone loss or break age of a dentalimplantor restor ativede vice may occurwhen an implantor abutmentis loadedbeyondits functionalcapabi lit y. Physiologicaland anatomicconditionsmay negativelyaffect thepe rf orm ance of followingshouldbe taken into consideration when placingdentalimplants: Poor bone quality Poor or al hygiene Medicalconditionssuch as blooddisor der s or uncontrolledhor monalconditionsIt is recommendedthat sma ll diameterim plantsnot be restoredwith angledabutmentsin the of small componentsinsidethe patientsmouthcarr ies a risk implantinto the osteotomydeeperthan the depthestablishedby thedrills can result in.

6 Str ippingthe driverhex inter face insidethe implant,strippingthe driver,cold- weldingof the mount-driver inter face to the implantor strippingthe walls of the osteotomythat may prev ent an effectiveinitial have demonstratedenhancedper formanceof OSSEOTITEI mplantsas comparedto ot her BIO MET3iDentalImplantsin patientswithpoor :For safe and effectiveuse of BIOMET3iDentalImplants,abutmentsand other surgicaland restorativedentalaccessories,these productsor devicesshouldonly be used by tr ained surgicaland restor ativete chniques requiredto pr operlyutiliz e these devicesar e highlyspecialized andcomplexpr oper techniquecan lead to implantfailure,loss ofsupportingbone,restor ation fracture, screwlooseningand.

7 All dentalimplantsand some abutmentsare suppliedsterileand ar esterilizedby an appropriate to individualproductlabelsfor ster ilizationinfor mation;all sterilepr oducts are labeled STERILE. Allproductssold ster ile are for singleuse beforethe expir ation date printedon th eproductlabel. Do not use ster ile productsif the packaginghas been not re- sterilize or autoclaveexceptwhereinstr uctionstodo so are pr ovidedon the pr oductlabel, in the SurgicalManual,in theRestor ative Manualor in any additionalmarketingliter atur e for that ovidednonsterile must be cleanedand sterilizedaccor ding to thedirectionsfoundinART630or the Sur gic al Manualprior to ,Sur ger y.

8 For a detailedexplanationof the proceduralprecautionsrefer to the Sur gical ing the planningphase,it isimportantto deter mine the ver tical dimension,the actualspaceavailablebetweenthe alveolarcr est and the opposingdenti tion, in order to confir m that theavailablespacewill accommodatethe pro posedabutmentand the final crow nre informationvar ies with each patientand abutment;ther efor e itshouldbe carefullyevaluatedbefor e plac ing any finalprosthesisshouldbe designedpr ior to the placementof the continuousirr igationwith a cool, ster ile irrigatingsolutionto avoidexcessivedamageto the surr oundingtis sue and to preventcompromisingos is mandatory dur ing all pr excessivepressure dur ing pr eparationof the bone site.

9 As the drillingspeedvariesbasedon the instrumentand the surgicalpr ocedure,recommendationsfor speedcanbe foundin the Sur gical sh arp instr umentsof the highestqualityshouldbe used for any surgicalpr traumatothe bone and surr oundingtissueenhances the potentialfor successfulos or der to eliminatecontaminantsand other sour ces ofinfection, all non- ster ile devicesshouldbe cleanedand/orsterilizedpr ior to us e,pe r the instr uctionson the individualpr ,Restoration:The healingper iod var ies dependingonthe qualityof the bone at the implantationsite, the tissueresponseto theimplanted deviceand the surgeon s evalu ation of the patient sbone densityat thetime of the ce appliedto the dentalimplantshouldbe avoidedduringthe healingper iod.

10 Properocclusionshouldbeevaluatedon the implantrestor ation to avoid :Potentialadver se eventsassociatedwith the use ofde ntal implantsmay include:Caut Fede ral La w restr ic ts thi s de vi ce to sal e by or on the orde r of a lice nse ddent is t or phys ic ian. Fail ur e to int egra te Loss of in te gr at ion Dehi scenc e requi ring bone gra ft ing Per fora ti on of the ma xi llary sinu s, infer io rbor der , ling ual plat e, labi al plat e, inf er ioralve ola r ca nal , gin giva In fe ct ion as reported by: abscess,fistul a,supp urat ion , inf lammat io n, radiol ucency Per si stent pai n, numb ness, pa rest hesia Hyperpl asi a Excessi ve bone los s requi ri ng in terven tio n Im pl ant br eakageor fra ctur e Syst em ic infe cti on Nerve inj ur y