Está en la página 1de 4

3MInternalUseOnly.

1. Whatarethedifferencesbetweenthe3MTrueDefinitionScannerand
LavaC.O.S.withversion3.0software?

Thenewdevice,the3MTrueDefinitionScannerbrings3Msunique3DinMotiontechnologytoa
leadingedgeandrobustplatform.

Asmallerergonomicwandhasthefamiliarfeelofahandpiece.
Therobustplatformisdevelopedby3Mengineerstoensurereliabilityandflexibility
Anopenandsecurecloudbasedplatformprovidesmorechoicestostore,shareand
connect

2. Whatdoesanopenandsecurecloudbasedplatformmean?

Open:
Thesystemdeliversdigitalimpressionsintwodifferentfiletypesaproprietaryfileformatandan
openSTLfileformat.Theproprietaryformatworkswithallofourintegratedandtrusted
connections.Theopenfileformatcanbedownloadedandimportedintoothersystemsand
workflows.
CloudBased:
Digitalimpressionfilesaredeliveredtodentallabsthroughthe3MConnectionCenter,whichis
accessibleviatheinternet.Thisiscommonlyreferredtoascloudbasedcomputing.
Secure:
The3MTrueDefinitionScannerandworkflowaredesignedforHIPAAandHITECHcompliance.
3. Whatisthedifferencebetweentrusted,integratedworkflowsandopenSTLworkflows?

Trustedandintegratedconnectionshavebeentestedandareseamless.TheopenSTLworkflows
requiretheimportofanSTLfileintothirdpartysoftware.

4. WhatcanbedonewithanopenSTLfile?
ManyCAD/CAMsystemstodayproduceproprietaryfileformatsthatonlyworkwithinone
environment.Thismeansthatdentallabpartnersneedamyriadofsystemstoworkwithdifferent
fileformats.ByofferingopenSTLfiles,dentistsanddentallabshavetheflexibilitytochoosethe
bestsolutionforthedesiredclinicaloutcomewithintheclearedrangeofindications.

Page1of4
10/16/2012
Version1

3MInternalUseOnly.

5. WhydidntyoubrandthisnewdevicewiththeLavaorESPEbrandnames?

Infocusgroupsandopinionleadermeetings,dentiststoldusthattheLavabrandimpliedthatthe
systemwasclosedandonlyworkswiththeLavasystemormaterials.TheESPEbrandisourdental
brand.Becausewehopetoentertheorthodonticspacewiththe3MTrueDefinitionScanner,itwas
requiredtoleavetheESPEbrandoff.Pleasenotethatthe3MTrueDefinitionScannerisnotcleared
byFDAfororthodontics.A510(k)iscurrentlyunderreviewattheFDAfororthodonticapplications.
Untilthe510kisclearedbytheFDA,3MESPEcannotmakeanyclaimsabouttheuse,safetyor
efficacyofthethe3MTrueDefinitionScannerwhenusedfororthodonticapplications.

6. Howmuchtestingwasdonewiththe3MTrueDefinitionScanner?
Thesystemhasbeentestedaroundtheworld,includingintheUS,Germany,Italy,Netherlandsand
Spain.FromApriltoOctober2012clinicianshavesuccessfullyseatedover371restorations,from
singleunittolongspanbridges,representing500unitsrestored.Inourclinicaltesting,thesystem
hasnotexperiencedanyservicefailuresandrestorationshaveafitratethatexceeds99.7+%.
7. AreyoustillsupportingtheLavaC.O.S.?

Yes,doctorscancontinuetousetheirLavaC.O.S.system.

8. Whereareyoulaunchingthe3MTrueDefinitionsystem?
The3MTrueDefinitionScannerwillbeavailableforsaleintheUSinOctober.Thesystemwillbe
launchedattheADAAnnualSessioninSanFranciscoOct1820.Moreinformationaboutfuture
launchdatesforadditionalcountrieswillbeavailableattheIDSshowinCologne,Germany.
9. Whatisthepriceofthe3MTrueDefinitionScanner?

The3MTrueDefinitionScannerisshatteringthehighfinancialbarrierofCAD/CAM
dentistrywithanunparalleledrecommendedretailUSmarketpriceofjust$11,995coupled
withdataplansaslowas$199permonth.Thescanneranddataplansareavailablefrom
qualified3MTrueDefinitionScannerChannelPartners.
10. CanItradeinmyLavaC.O.S.scanner?CanIupgrademyLavaC.O.S.?
3MhasanattractiveprogramforexistingLavaC.O.S.customerstopurchasethe3MTrueDefinition
Scanneratasignificantlydiscountedprice.The3MTrueDefinitionScannerisbuiltonanew
hardwareplatformandthewandandcomponentsarenotcompatiblewiththeLavaC.O.S.The
systemswithdealersandthesystemsthatweredonatedtoUniversitieswillhavespecific
programs.Pleasecontactyourlocal3MESPEClinicalDigitalSpecialist.

Page2of4
10/16/2012
Version1

3MInternalUseOnly.

11. Withthe3MTrueDefinitionScanner,arethereanychangeswiththeLaboratoryWorkflow?
AlaboratorythatisalreadyworkingwithdigitalfilesfromtheLavaC.O.S.canworkwiththeTrue
Definitionscans.However,labswhoaremarkingmarginswillwanttoupgradetothenewsoftware
whichwillbecompatiblewithboththeLavaC.O.S.andTrueDefinitionsystems.Oncethisfree
upgradeisavailable,wewillnotifyalllabsthatarecurrentlymarkingmarginswithoursoftware.
Forlabsnewtodigitalimpressions(newlab)withthe3MTrueDefinitionScanner,3Mrequiresthe
newlabtopartnerwithaCertifiedMarginMarkingLabforthefirst3040cases.Asaservicetothe
newlab,theseinitialcasesaremarginmarkedbytheCertifiedMarginMarkingLab.Thenewlab
thenreceivestheSLAmodeland/ormarginmarkeddigitalfiletocompletethecase.Certified
MarginMarkingLabstypicallycharge$8perdieforthisserviceanddonotseethecustomername
orinformation.Oncethenewlabhascompleted3040restorations,theywillhavetheoptionto
purchaseadatapackagethatwillallowthemtomarkthemarginsthemselves.Thiswillensurethe
highestchanceforsuccessimplementingthedigitalprocessforthelabandthedoctor.

12. WhataretheoptionsforChairsideCAD/CAM?
Thesystemisdesignedtointegratewithinofficedesignandmillsystems.Thesystemwastested
withtheE4Dmillanddesignsystemanditisatrustedconnection.3MESPEanticipatesadditional
trustedconnections.

13. What indications are possible with the 3M True Definition Scanner?
The system supports inlays, onlays, veneers, crowns, bridges and restorations on implant abutments.
3M provides open STL files to give dentists and dental labs more choices within the range of cleared
indications and does not support any use outside this range. It is our goal to continue to grow our
base of cleared indications and integrated connections.

14. Doyouhaveanimplantworkflowwiththe3MTrueDefinitionScanner?
ThescanningofaBellaTekBiomet3iEncodeisareleasedworkflowfortheLavaC.O.S.The3MTrue
DefinitionScannerisnotclearedbyFDAforscanningaBellaTekBiomet3iEncode.A510(k)is
currentlyunderreviewattheFDAforthisindication.Untilthe510kisclearedbytheFDA,
3MESPEcannotmakeanyclaimsaboutnewindicationsforuse,safetyorefficacyofthe3MTrue
DefinitionScannerforthisworkflow.
15. AsamanufacturerofadentalConeBeamCTsystem,howwouldweintegratewith3M?
Atpresentthe3MTrueDefinitionScannerisnotindicatedforpresurgicalimplantplanningorthe
manufactureofsurgicalguidancestentsandwedo not have a 510(k) under review for this
functionality. 3M ESPE cannot make any claims as to the safety and efficacy of the 3M True

Page3of4
10/16/2012
Version1

3MInternalUseOnly.

Definition Scanner when used for pre-surgical implant planning or surgical guidance stents . It is our
goal to continue to grow our base of cleared indications and integrated connections.

16. Doesthe3MTrueDefinitionScannerusepowder?
The3MTrueDefinitionScannerusesalightdusting.3Misunwillingtosurrendertheaccuracythat
powderprovides.Predictableclinicaloutcomesdependonhighresolutionandrepeatability.The
3MTrueDefinitionScannerrequiresonlyalightdustingthatiseasilymanaged.Inourclinical
evaluation,restorationshadafitratethatexceeded99.7%.
17. Doesthe3MTrueDefinitionScannerprovidecolor?Howcanyousayyoursystemdeliversatrue
replicawhenyourfilesarenotincolor?
No,the3MTrueDefinitionScannerdoesnotprovidecolor.Muchlikemedicalimagingsystems,the
TrueDefinitionScannerprovideshighlyaccuratemonochromaticdata.Inaddition,digital
impressionsfromtheTrueDefinitionScannermaybeviewedinahighlymagnified,3Dview.This
makesiteasyforadentaltechniciantoaccuratelydiscernthemargin.
18. Isitpossibletointegratethe3MTrueDefinitionScannerwithaCERECMCXLorCERECCompact
MillingUnit?
OpenSTLfilesareavailablefromthe3MConnectionCenterandcanbeimportedintoanysystem
acceptingthisfileformat.However,wearenotawarethatSironasupportsthisformatand
workflowatthistime.
19. Canadentistpurchasethedemonstrationlaptop?
Thelaptopisfordemonstrationpurposesonlyandisnotintendedforintraoraluse.
20. Doesthe3Msystemonlyworkwith3MESPEand/orLavaMaterials?
Withtheopenplatform,dentistsandlabscanuseothermaterialsaswellasLavaMaterials.
21. WhathappensafteraDentistpurchasesthesystem?
3Mhasacomprehensivetrainingprogramforthe3MTrueDefinitionScanner,includinghandson
oneononetraininginthedentistsoffice.
22. WhathappensifIbreakmywand?
The3MTrueDefinitionwandisdesignedwithoutanymovingpartsandisveryrobust.Ifitwould
fail,itiscoveredunderyourserviceagreement.

Page4of4
10/16/2012
Version1

También podría gustarte