Guidance For Industry and FDA Staff Class II Special Controls Guidance Document: Root Form Endosseous Dental Implants and Endosseous Dental Abutments

10/9/2015
SearchforFDAGuidanceDocuments>GuidanceforIndustryandFDAStaffClassIISpecialControlsGuidanceDocument:RootformEndosseousDentalImplantsandEndosseousDentalAbutments
U.S.FoodandDrugAdministration
ProtectingandPromotingYourHealth
GuidanceforIndustryandFDA
StaffClassIISpecialControls
GuidanceDocument:Rootform
EndosseousDentalImplants
andEndosseousDental
Abutments
Documentissuedon:May12,2004
ThedraftofthisdocumentwasissuedonMay14,2002
Thisdocumentsupersedes:
ClassIISpecialControlsGuidanceDocument:RootformEndosseousDental
ImplantsandAbutmentsDraftGuidanceforIndustryandFDAissuedMay14,
2002
OverviewofInformationNecessaryforPremarketNotificationSubmissionsfor
EndosseousImplantsFinal,04/21/1999
http://www.fda.gov/RegulatoryInformation/Guidances/ucm072424.htm
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InformationNecessaryforPremarketNotificationSubmissionsForScrewType
EndosseousImplants,12/09/1996
GuidanceFortheArrangementandContentofaPremarketApproval(PMA)
ApplicationforAnEndosseousImplantForProstheticAttachment,5/16/89
(partsof)CalciumPhosphate(CaP)CoatingDraftGuidanceforPreparationof
FDASubmissionsforOrthopedicandDentalEndosseousImplants,2/21/97
Forquestionsregardingthisdocument,contactAndrewSteenat3017966284orby
emailatandrew.steen@fda.hhs.gov(mailto:andrew.steen@fda.hhs.gov)
U.S.DepartmentofHealthandHumanServices
FoodandDrugAdministration
CenterforDevicesandRadiologicalHealth
DentalDeviceBranch
DivisionofAnesthesiology,InfectionControl,GeneralHospital,
andDentalDevices
OfficeofDeviceEvaluation
TABLEOFCONTENTS
1.INTRODUCTION
2.BACKGROUND
3.THECONTENTANDFORMATOFANABBREVIATED510(k)SUBMISSION
4.SCOPE
5.DEVICEDESCRIPTION
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6.RISKSTOHEALTH
7.MATERIALCOMPOSITION
8.MECHANICALPROPERTIES
9.IMPLANTTOABUTMENTCOMPATIBILITY
10.CORROSIONTESTING
11.MODIFIEDSURFACESINFORMATION
12.CLINICALSTUDIES
13.LABELING
APPENDIXISUGGESTEDFORMATFORTESTREPORTS
Preface
PublicComment
WrittencommentsandsuggestionsmaybesubmittedatanytimeforAgency
considerationtoDocketsManagementBranch,DivisionofManagementSystemsand
Policy,OfficeofHumanResourcesandManagementServices,FoodandDrug
Administration,5630FishersLane,Room1061,(HFA305),Rockville,MD,20852.
Alternatively,electroniccommentsmaybesubmittedtoRegulations.gov
(http://www.regulations.gov).Whensubmittingcomments,pleaserefertoDocket
No.02D0113.CommentsmaynotbeacteduponbytheAgencyuntilthedocument
isnextrevisedorupdated
AdditionalCopies
AdditionalcopiesareavailablefromtheInternet.Youmayalsosendanemail
requesttoCDRHGuidance@fda.hhs.gov(mailto:CDRHGuidance@fda.hhs.gov)
toreceiveacopyoftheguidance.Pleaseusethedocumentnumber1389toidentify
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theguidanceyouarerequesting
GuidanceforIndustryandFDAStaff
ClassIISpecialControlsGuidance
Document:RootformEndosseousDental
ImplantsandEndosseousDentalImplant
Abutments
1.Introduction
Thisguidancedocumentwasdevelopedasaspecialcontrolguidancetosupportthe
reclassificationoftherootformendosseousdentalimplantdeviceintoclassIIandthe
reclassificationoftheendosseousdentalimplantabutmentdeviceintoclassII.FDAis
issuingthisguidanceinconjunctionwithaFederalRegisternoticeannouncingthe
finalrulereclassifyingthesedevicetypes.Bladeformendosseousdentalimplantswill
remaininclassIIIandarenotwithinthescopeofthisguidance.
Rootformendosseousdentalimplantdevicesarecharacterizedbyfourgeometrically
distincttypes:basket,screw,solidcylinder,andhollowcylinder.Therootform
endosseousdentalimplantdevicereferstothefixturethatissurgicallyimplantedinto
thepatientsbone.Therootformendosseousdentalimplantdeviceisintendedtobe
surgicallyplacedintheboneoftheupperorlowerjawarchestoprovidesupportfor
prostheticdevices,suchasanartificialtooth,inordertorestorethepatientschewing
function.
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Theendosseousdentalimplantabutmentdeviceisintendedtobeusedwiththeroot
formendosseousdentalimplanttoaidinprostheticrehabilitation.Aftertherootform
endosseousdentalimplantissurgicallyplacedandhashealed,theendosseous
dentalimplantabutmentdeviceispermanentlyattachedtoitinasecondsurgical
procedure.Theendosseousdentalimplantabutmentextendsabovethegum,i.e.,itis
thetransgingivalcomponent,whichservesasthesupportfortheartificialtoothor
otherprosthetic.However,iftheendosseousdentalimplantincludesanintegral
transgingivalcomponent,itdoesnotneedtobeusedwithanabutment.
Followingtheeffectivedateofthefinalrulereclassifyingthesedevices,anyfirm
submittinga510(k)forarootformendosseousdentalimplantdeviceorendosseous
dentalimplantabutmentdevicewillneedtoaddresstheissuescoveredinthisspecial
controlguidance.However,thefirmneedonlyshowthatitsdevicemeetsthe
recommendationsoftheguidanceorinsomeotherwayprovidesequivalent
assurancesofsafetyandeffectiveness.
Thefirmmustshowthatitsdeviceaddressestheissuesofsafetyandeffectiveness
identifiedinthisguidance,eitherbymeetingtherecommendationsofthisguidanceor
bysomeothermeansthatprovidesequivalentassurancesofsafetyand
effectiveness.
TheLeastBurdensomeApproach
Theissuesidentifiedinthisguidancedocumentrepresentthosethatwebelieveneed
tobeaddressedbeforeyourdevicecanbemarketed.Indevelopingtheguidance,we
carefullyconsideredtherelevantstatutorycriteriaforAgencydecisionmaking.We
alsoconsideredtheburdenthatmaybeincurredinyourattempttofollowthe
guidanceandaddresstheissueswehaveidentified.Webelievethatwehave
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consideredtheleastburdensomeapproachtoresolvingtheissuespresentedinthe
guidancedocument.If,however,youbelievethatthereisalessburdensomewayto
addresstheissues,youshouldfollowtheproceduresoutlinedintheguidance,A
SuggestedApproachtoResolvingLeastBurdensomeIssues
(/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceProvis
ionsofFDAModernizationAct/ucm136685.htm).
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2.Background
FDAbelievesthatspecialcontrols,whencombinedwiththegeneralcontrols,willbe
sufficienttoprovidereasonableassuranceofthesafetyandeffectivenessofaroot
formendosseousdentalimplantorendosseousdentalimplantabutmentdevice.
Thus,amanufacturerwhointendstomarketadeviceofeitherofthesegenerictypes
should(1)conformtothegeneralcontrolsoftheFederalFood,Drug,andCosmetic
Act(theAct),includingthepremarketnotificationrequirementsdescribedin21CFR
807,SubpartE,(2)addressthespecificriskstohealthassociatedwithrootform
endosseousdentalimplantorendosseousdentalimplantabutmentdevicesidentified
inthisguidance,and(3)obtainasubstantialequivalencedeterminationfromFDA
priortomarketingthedevice.
Thisspecialcontrolguidancedocumentidentifiestheclassificationregulationsand
productcodesforrootformendosseousdentalimplantsandendosseousdental
implantabutmentdevices(Pleaserefertosection4.Scope).Inaddition,other
sectionsofthisspecialcontrolguidancedocumentlisttheriskstohealthidentifiedby
FDAanddescribemeasuresthat,iffollowedbymanufacturersandcombinedwiththe
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generalcontrols,willgenerallyaddresstherisksassociatedwiththesedevicesand
leadtoatimelypremarketnotificationsubmission(510(k))reviewandclearance.This
documentsupplementsotherFDAdocumentsregardingthecontentrequirementsof
a510(k).Youshouldalsoreferto21CFR807.87andHowtoPreparea510(k)
SubmissioninCDRHsDeviceAdvice
(/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Prem
arketSubmissions/PremarketNotification510k/default.htm).
Asdescribedintheguidanceentitled,TheNew510(k)ParadigmAlternate
ApproachestoDemonstratingSubstantialEquivalenceinPremarket
NotificationsFinalGuidance
(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080187.htm),
amanufacturermaysubmitaTraditional510(k)orhastheoptionofsubmittingeither
anAbbreviated510(k)oraSpecial510(k).FDAbelievesanAbbreviated510(k)
providestheleastburdensomemeansofdemonstratingsubstantialequivalencefora
newdevice,particularlyonceFDAissuesaclassIIspecialcontrolsguidance
documentforthatdevice.Additionally,manufacturersconsideringmodificationsto
theirowncleareddevicesmaylessentheregulatoryburdenbysubmittingaSpecial
510(k).
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3.TheContentandFormatofanAbbreviated510(k)
Submission
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AnAbbreviated510(k)submissionmustincludetherequiredelementsidentifiedin21
CFR807.87,includingtheproposedlabelingforthedevicesufficienttodescribethe
device,itsintendeduse,andthedirectionsforitsuse.InanAbbreviated510(k),FDA
mayconsiderthecontentsofasummaryreporttobeappropriatesupportingdata
withinthemeaningof21CFR807.87(f)or(g)therefore,werecommendthatyou
includeasummaryreport.Thereportshoulddescribehowthisspecialcontrol
guidancedocumentwasusedduringthedevicedevelopmentandtestingandshould
identifythemethodsortestsused.Thereportshouldalsoincludeasummaryofthe
testdataoradescriptionoftheacceptancecriteriaappliedtoaddresstherisks
identifiedinthisdocument,aswellasanyadditionalrisksspecifictoyourdevice.This
sectionsuggestsinformationtofulfillsomeoftherequirementsof21CFR807.87,as
wellassomeotheritemsthatwerecommendyouincludeinanAbbreviated510(k).
Coversheet
ThecoversheetshouldprominentlyidentifythesubmissionasanAbbreviated510(k)
andcitethetitleofthisspecialcontrolsguidancedocument.
Proposedlabeling
Proposedlabelingshouldbesufficienttodescribethedevice,itsintendeduse,and
thedirectionsforitsuse.(Pleaserefertosection15.Labelingforspecificinformation
thatshouldbeincludedinthelabelingfordevicesofthetypescoveredbythis
guidancedocument.)
Summaryreport
Werecommendthatthesummaryreport1containthefollowing.
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Descriptionofthedeviceanditsintendeduse
Werecommendthatthedescriptionincludeacompletediscussionoftheperformance
specificationsand,whenappropriate,detailed,labeleddrawingsofthedevice.
(Pleaserefertosection5.DeviceDescriptionforspecificinformationthatwe
recommendyouincludeinthedevicedescriptionfordevicesofthetypescoveredby
thisguidancedocument.)Youshouldalsosubmitanindicationsforuseenclosure.2
Descriptionofdevicedesignrequirements
Werecommendthatyouincludeabriefdescriptionofthedevicedesignrequirements.
Identificationoftheriskanalysismethod
Werecommendthatyouidentifytheriskanalysismethod(s)youusedtoassessthe
riskprofileingeneral,aswellasthespecificdevicesdesign,andtheresultsofthis
analysis.(Pleaserefertosection6.RiskstoHealthfortheriskstohealthgenerally
associatedwiththeuseofthesedevicesthatFDAhasidentified.)
Discussionofthedevicecharacteristics
Werecommendthatyoudiscussthedevicecharacteristicsthataddresstherisks
identifiedinthisclassIIspecialcontrolsguidancedocument,aswellasanyadditional
risksidentifiedinyourriskanalysis.
Descriptionoftheperformanceaspects
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Werecommendthatyouincludeabriefdescriptionofthetestmethod(s)youhave
usedorintendtousetoaddresseachperformanceaspectidentifiedinsections712
ofthisclassIIspecialcontrolsguidancedocument.Ifyoufollowasuggestedtest
method,youmaycitethemethodratherthandescribingit.Ifyoumodifyasuggested
testmethod,youmaycitethemethodbutshouldprovidesufficientinformationto
explainthenatureofandreasonforthemodification.Foreachtest,youmayeither(1)
brieflypresentthedataresultingfromthetestinclearandconciseform,suchasa
table,or(2)describetheacceptancecriteriathatyouwillapplytoyourtestresults.3
(Seealso21CFR820.30
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
FR=820.30),SubpartCDesignControlsundertheQualitySystemRegulation.)
Relianceonstandards
Ifanypartofthedevicedesignortestingreliesonarecognizedstandard,we
recommendthatyouincludeeither:
astatementthattestingwillbeconductedandmeetspecifiedacceptancecriteria
beforetheproductismarketed
adeclarationofconformitytothestandard.4
(Section514(c)(1)(B)oftheAct).Thismeansthattestingmustbecompletedbefore
yousubmitadeclarationofconformitytoarecognizedstandard.Formore
information,refertotheFDAguidance,UseofStandardsinSubstantial
EquivalenceDeterminationsFinalGuidanceforIndustryandFDA
(/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm0737
52.htm).
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IfitisnotclearhowyouhaveaddressedtherisksidentifiedbyFDAoradditionalrisks
identifiedthroughyourriskanalysis,wemayrequestadditionalinformationabout
aspectsofthedevicesperformancecharacteristics.Wemayalsorequestadditional
informationifweneedittoassesstheadequacyofyouracceptancecriteria.(Under
21CFR807.87(l),wemayrequestanyadditionalinformationthatisnecessaryto
reachadeterminationregardingsubstantialequivalence.)
AsanalternativetosubmittinganAbbreviated510(k),youmaysubmitaTraditional
510(k)thatprovidesalloftheinformationanddatarequiredunder21CFR807.87and
describedinthisguidance.ATraditional510(k)shouldincludeallofyourmethods,
data,acceptancecriteria,andconclusions,seealsoAppendixI.SuggestedFormat
forTestReports.Manufacturersconsideringmodificationstotheirowncleared
devicesshouldconsidersubmittingSpecial510(k)s.
Thegeneraldiscussionaboveappliestoanydevicesubjecttoaspecialcontrols
guidancedocument.Thefollowingisaspecificdiscussionofhowyoushouldapply
thisspecialcontrolsguidancedocumenttoapremarketnotificationsubmissionfora
rootformendosseousdentalimplantoranendosseousdentalimplantabutment
device.
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4.Scope
Thescopeofthisdocumentislimitedtothedevicedescribedbelow.
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FDAidentifiesthegenericendosseousdentalimplantdevicein21CFR872.3640,
productcodeDZE,asfollows:
21CFR872.3640Endosseousimplant.
Anendosseousimplantisadevicemadeofamaterialsuchastitaniumintendedtobe
surgicallyplacedintheboneoftheupperorlowerjawarchestoprovidesupportfor
prostheticdevices,suchasartificialteeth,andtorestorethepatientschewing
function.
Rootformendosseousdentalimplantdevicesarecharacterizedbyfourgeometrically
distincttypes:basket,screw,solidcylinder,andhollowcylinder.Incontrasttoroot
formendosseousimplants,bladeformendosseousdentalimplantsareflatandhave
differentsurgicalrequirements.Thisguidancedoesnotapplytobladeform
endosseousdentalimplants,whichremaininclassIII.
FDAidentifiesthegenericendosseousdentalimplantabutmentdevice,asannounced
inthefinalruleintheFederalRegisterreclassifyingthesedevicesissuedconcurrently
withthisguidance,in21CFR872.3630,productcodeNHA,asfollows:
21CFR872.3630Endosseousdentalimplantabutment.
Anendosseousdentalimplantabutmentdeviceisapremanufacturedprosthetic
componentdirectlyconnectedtotheendosseousdentalimplantandisintendedfor
useasanaidinprostheticrehabilitation.
FDAconsidersanyaccessoryintendedtobedirectlyconnectedtoanendosseous
dentalimplantandplacedinthemouthformorethan1hourtobeanabutmentwithin
theidentificationsetforthin21CFR872.3630.However,temporaryaccessoriesused
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withendosseousdentalimplants,i.e.,accessoriesthatcontacttissueforlessthan1
hour,areexemptfrom510(k)requirements.21CFR872.3980.
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5.DeviceDescription
Werecommendthatyouincludeacompetediscussionoftheperformance
specificationsand,whenappropriate,detailed,labeleddrawingsofthedevice.We
alsorecommendthatyouincludeadescriptionofdevicefeatures,withdimensions
andtolerances.Examplesoffeaturesincludeantirotationalfeatures,suchasinternal
orexternalhexagonalfeatures,flataxialsurfacefeaturesonimplants,fins,threads,or
verticalantirotationslots.
Werecommendthatyouincludedrawingsshowingalldimensionsandtolerances.If
yourdrawinglabelsarenotinEnglishorifyourdrawingsarereproducedfrom
manufacturingprints,pleasetranslateandrelabelthemasnecessary,andensure
thatyouuseanadequatefontsize,beforeyousubmityourdrawings.
Insubmissionsforrootformendosseousdentalimplants,werecommendthatyou
providethecharacteristicsoftheabutmentconnectionforeachtypeandsizeof
implantinthatsubmission.Insubmissionsforendosseousdentalimplantabutments,
werecommendthatyouprovidethecharacteristicsoftheabutmentconnectionfor
eachtypeandsizeofabutmentinthatsubmission.Inallsubmissions,these
characteristicsshouldincludeplatformsizeandshape,andconnectiontype.
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6.RiskstoHealth
Inthetablesbelow,FDAhasidentifiedtheriskstohealthgenerallyassociatedwith
theuseoftherootformendosseousdentalimplantandendosseousdentalimplant
abutmentdevicesaddressedinthisdocument.Themeasuresrecommendedto
mitigatetheseidentifiedrisksaredescribedinthesectionsofthisguidancedocument
asshowninthetablebelow.Youshouldalsoconductariskanalysis,before
submittingyour510(k),toidentifyanyotherrisksspecifictoyourdevice.The510(k)
shoulddescribetheriskanalysismethod.Ifyouelecttouseanalternativeapproach
toaddressaparticularriskidentifiedinthisguidancedocument,orhaveidentified
risksadditionaltothoseintheguidance,youshouldprovidesufficientdetailtosupport
theapproachyouhaveusedtoaddressthatrisk.
RisksandMitigationMeasuresforRootFormEndosseousDentalImplants
Identifiedrisk
Recommendedmitigationmeasures
(guidancesectionnumbers)
Inadequatefunctionordevicefailure
(mobility,lossofintegrity)
7,8,9,10
Damagetoexistingdentition
8,11,12
Infection
(localandsystemic,includingbacterialendocarditis)
10,11,12,13
Injuryduringsurgery,perforation
(sinus,alveolarplates),postsurgicalparathesia
11,12,13
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Theriskstohealththataregenerallyassociatedwiththeuseofendosseousdental
implantabutmentdevicesarelistedinthetablebelow.
RisksandMitigationMeasuresforEndosseousDentalImplantAbutments
Identifiedrisk
Recommendedmitigationmeasures
(guidancesectionnumbers)
Inadequatefunction
(incompatibility)
Devicefailure
(mobility,lossofintegrity)
7,8,9,10
Damagetoexistingdentition
8,9,11,12
Rootformendosseousdentalimplantandendosseousdentalimplantabutment
devicesincludepartsthathavepermanentcontactwithtissue/boneandblood.We
recommendthatyouevaluatethebiocompatibilityofthematerialsinthesepartsas
describedintheInternationalStandardOrganization(ISO)standardISO10993,
BiologicalEvaluationofMedicalDevicesPart1:EvaluationandTesting.
Generally,whenitismoreappropriatetotestrestorativematerialsandcementsafter
curing,werecommendthatyouevaluatethesematerialsasdescribedinISO
7405:1997DentistryPreclinicalEvaluationofBiocompatibilityofMedical
DevicesUsedinDentistryTestMethodsforDentalMaterials.Wealso
recommendthatyoudocumenttheresultsinyourdesignhistoryfileasapartofthe
QualitySystemsRequirements(21CFR820.30).5Youshouldselecttestsappropriate
forthedurationandlevelofcontactwithyourdevice.Ifidenticalmaterialsareusedin
apredicatedevicewiththesametypeanddurationofpatientcontact,youmay
identifythepredicatedeviceinlieuofperformingbiocompatibilitytesting.
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7.MaterialComposition
Werecommendthatyouincludethefollowinginformationforallcomponents:
thematerialidentity
hechemicalcompositionofmajorconstituentsandanticipatedimpurities,unless
declaringconformancetoamaterialsstandard.
Materialsaddressedbythestandardscitedinthisguidancedocumentarecommonly
usedinendosseousdentalimplants.
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8.MechanicalProperties
Whereindicatedbytheriskanalysis,werecommendthatyouincludethefollowing
informationforthefinisheddevice:
adescriptionofmechanicalproperties
themethodologyfordeterminingthemechanicalproperties,ifatestingstandard
wasnotused.
Werecommendthatyouconductfatiguetestingfordevicesthat:
consistofangledabutments
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areimplantorabutmentdesignsthataresignificantlydifferentfrompredicate
devicesor
havedesignfeaturesortechnologicalcharacteristicsthathavenotbeenpreviously
clearedformarket.
Werecommendthatyoutestthefinisheddeviceorcomponentsthathaveundergone
thesamemanufacturingprocessesasafinisheddevice.Youshouldexplainhowthe
propertiesofyourdeviceshowadequatedeviceperformance.Werecommendthat
youfollowAmericanSocietyforTestingandMaterials(ASTM)F8691Standard
PracticeforSurfacePreparationandMarkingofMetallicSurgicalImplantsformarking
thesurfaceofyourdeviceduringmanufacture.WerecommendthatyoufollowASTM
F60198StandardPracticeforFluorescentPenetrantInspectionofMetallicSurgical
Implantsforanyfluorescentpenetrantinspectionthatispartofyourquality
assurance.
Someimplantsdonotuseaseparateabutmentcomponent.However,forthosethat
do,werecommendthatyoutesttheassembledimplant/abutmentsystem.Ifthe
implantorabutmentismarketedbyanothermanufacturer,youshouldfollowthe
assemblyinstructionsthatmanufacturerprovides.
Werecommendthatyousetuptestingtoensurethattheimplantorimplant/abutment
systemissubjectedtobothcompressiveandshear(lateral)forces,withnolateral
constraintoccurring.Testingconditionsshouldmimicactualintraoraluseasmuchas
possible.
Werecommendthatyouperformtestingofangledabutmentsatthegreatest
angulationintended(i.e.,theworstcasescenario).Abutmentangulationgreaterthan
30shouldbesupportedbyclinicaldata.Thetestsetupshouldclamptheimplantso
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thattheimplantslongaxismakesa30anglewiththeloadingdirectionofthetesting
machine,unlessyouaretestinganangledabutmentofgreaterthan20.Forangled
abutments,thetestsetupshouldleaveatleast10oftheangulationuncorrected(i.e.,
a30abutmentshouldbetestedwiththeimplantslongaxisat40anda25
abutmentshouldbetestedwiththeimplantslongaxisat35).Theimplantshouldbe
supported3mmbelowtheanticipatedcrestalbonelevel,simulating3mmofbone
resorption.
Forendosseousdentalimplantsthatincludematerialsinwhichcorrosionfatiguehas
beenreportedorisexpectedtooccur,orforsystemsthatincludepolymeric
components,werecommendthatyouperformfatiguetestinginwater,innormal
salineorinaphysiologicalmediumat37C,at2Hzfrequency.Youshoulddetermine
themaximumload(endurancelimit)yourdevicecanwithstandfor2x106cycles.For
allothersystems,itmaybeappropriatetoperformthetestinairat20C,at315Hz
frequencyfor5x106cycles.
Werecommendthatyoubegintestingataloadofapproximately80%ofthestatic
failureloadofyourdevicesystemanddecreasetheloaduntiltheendurancelimitis
reached.Werecommendthatyoutesttwo(preferablythree)specimenstofailureat
eachload,andthreespecimensattheendurancelimit.Ifanyofthespecimensfailat
theexpectedendurancelimit,werecommendthatyoureducetheloadandrepeatthe
testsuntilaloadisreachedatwhichpreferablythreespecimensreachtherequired
numberofcycles(2x106or5x106,dependingonthetestmedium).Werecommend
thatyoutest4ormoreloadsand12ormorespecimens.
Werecommendthatyouidentifythecriticalfailurepointandthelocationoffailure
initiationonthedevicecomponentthatfails.Failureisdefinedasmaterialyielding,
deformation,orfracture.Werecommendthatyoucomparetestingresultsobserved
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fortheclaimedpredicatedevice(s).Youshouldincludeagraphoftheloadversus
numberofcyclescurvealongwithtestingresultsanddatapresentedintabularform.
Youmayuseanalternateapproachtotheloadversusnumberofcyclescurve.This
mayallowtheuseoffewersamples.Oneapproachistoselectaloadthatis10%
belowthestaticfailureloadofthedevicesystem.Werecommendtesting5ormore
samplesattheselectedload.Allsamplesshouldwithstand5millioncycles.Ifany
samplesfail,werecommendthatyoutest5additionalsamplesataslightlylower
load.Ifyouusethisalternateapproach,werecommendthatyouperformthetesting
inasimulatedphysiologicalsolutionasdescribedaboveunlessthematerialsarenot
subjecttocorrosionfatigueandtherearenoplasticcomponents.Ifyouare
developinganalternativeapproach,werecommendthatyoureferenceASTMF1108
97StandardSpecificationforTitanium6Aluminum4VanadiumAlloyCastingsfor
SurgicalImplants(UNSR56406).
Backtothetop
9.ImplanttoAbutmentCompatibility
Implanttoabutmentcompatibilitycanbedemonstratedduringthetestingdescribed
aboveinsection8.MechanicalProperties.Ifyouidentifyalegallymarketed
abutmentorimplantmadebyanothermanufacturerascompatiblewithyourabutment
orimplant,werecommendthatyouexplainhowyoudeterminedthatcompatibilityand
ensuredthatyourtoleranceswillallowyourdevicetobecompatible.Ifyoucannot
establishimplanttoabutmentcompatibilitybasedsolelyondescriptiveinformation,
because,forexample,youcannotobtainthemanufacturingtolerancesforthe
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platformsizeandshapeofanothermanufacturersdevice,werecommendthatyou
describetheperformancetestingthatyouconductedandtheresultsthatestablish
implanttoabutmentcompatibility.6
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10.CorrosionTesting
Werecommendthatyouconductcorrosiontestingwhentheimplantsystemincludes
componentsfabricatedfromdissimilarmetalsthathavenotbeenusedtogether
beforeinsimilarapplications.Youshouldperformthistestinginasimulated
physiologicalsolutionat37C.Passivated(i.e.,finisheddevicecondition)and
nonpassivatedmetalsurfacesshouldbeevaluated.Werecommendthattesting
assess:
corrosionpotentialofeachmetaloralloy
couplepotentialfortheassembleddissimilarmetalimplantsystemand
orrosionratefortheassembleddissimilarmetalimplantsystem.
Foroneexampleofatestmethodforpittingorcrevicecorrosion,pleaseseeASTM
F74687(1994)StandardTestMethodforPittingorCreviceCorrosionofMetallic
SurgicalImplantMaterials.
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11.ModifiedSurfacesInformation
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Werecommendthatyoudescribetheimplantsurfacecharacteristicsifthesurfaceis
modifiedorhaspropertiesclaimedtofacilitatebonedeposition.Youshouldinclude
informationonthenatureof,andprocessesbywhich,surfacesaremodifiedsuchas
coatings,blastedsurfaces,etchedsurfaces,orothersurfacetreatmentsthatare
applied.
Ifthemodifiedsurfaceissignificantlydifferentfrompredicatedevices,werecommend
thatyouprovidetheinformationdescribedbelow.
CeramicCoatingInformation
Werecommendthatyouincludetheinformationlistedbelowforanimplantcoated
withaceramiccoatingsuchashydroxyapatiteorcalciumphosphate.
particlesizeandparticlesizedistributionofthepowderusedforthecoating
averageporositysizeforthecoating
overallporevolumeforthecoating
identityoftheareaoftheimplanttobecoated
scanningelectronmicroscopypicturesat100Xofthecoatedimplantsurfacesand
ofacrosssectionedareaofthedeviceshowingthecoatinginterface
measurementsofcoatingthicknessandtolerances
chemicalanalysisofthepowderbeforeandaftercoating,includingCa/Pratiosin
atomicpercentandelementalanalysis
totalpercentageofallcrystallinephasesinthecoatingandtotalpercentageof
crystallinehydroxyapatiteinthecoating
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typeofdepositionprocessusedandthepostdepositiontreatment
xraydiffractionpatternofthepowderandthecoatingintermsofrelativeintensity
versusdiffractionangle
urfaceroughnessofthecoating
abrasioncharacteristicsofthecoating,includingtheabrasiontestingmethodology.
Wealsorecommendthatyouincludestatictensileandshearbondingstrengths
betweenthecoatingandtheimplantsurfacewithtestingfrom5ormoresamples
includedintheaverages.Werecommendthefollowingstandards,whereappropriate
toyourdevicescomposition:
ASTMF116098StandardTestMethodforShearandBendingFatigueTestingof
CalciumPhosphateandMetallicMedicalCoatings
ASTMF114799StandardTestMethodforTensionTestingofCalciumPhosphate
andMetalCoatings
Coatings
ASTMF165895StandardTestMethodforShearTestingofCalciumPhosphate
ASTMF165995StandardTestMethodforBendingandShearTestingofCalcium
PhosphateCoatingsonSolidMetallicSubstrates
ForCAphosphatecoatingspleaseseeASTMF160995StandardSpecificationfor
CalciumPhosphateCoatingsforImplantableMaterials.Forothertypesofceramic
coatings,ASTMF150195StandardTestMethodforTensionTestingofCalcium
PhosphateCoatingsmaybeusefulindevisingyourowntestmethod.
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MetallicCoatingInformation
Werecommendthatyouincludetheinformationlistedbelowforanimplantcoated
withametalliccoating:
completechemicalcompositionofthepowderusedforthecoatingandofthe
coatingitself
coatingthicknessandporosity
meanvolumepercentofvoids
surfaceroughnessofthecoating
identityoftheareaoftheimplanttobecoated
scanningelectronmicroscopypicturesat100Xofthecoatedimplantsurfacesand
ofacrosssectionedareaofthedeviceshowingthecoatinginterface
abrasioncharacteristicsofthecoating,includingtheabrasiontestingmethodology.
Wealsorecommendthatyouincludestatictensileandshearbondingstrengthsofthe
coatingtotheimplantwithresultsfrom5ormoresamplesincludedintheaverages.
Werecommendthefollowingstandards,whereappropriatetoyourdevices
composition:
ASTMF104495StandardTestMethodforShearTestingofPorousMetal
Coatings
andMetalCoatings
ASTMF116098StandardTestMethodforShearandBendingFatigueTestingof
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CalciumPhosphateandMetallicMedicalCoatings
ASTMF158095StandardSpecificationforTitaniumandTitanium6%Aluminum
4%VanadiumAlloyPowdersforCoatingSurgicalImplants.
BlastedSurfacesInformation
Werecommendthatyouincludetheinformationlistedbelowforanimplantwitha
blastedsurface:
identityofanysurfacetreatmentsthatblasttheimplant
compositionoftheparticles
identityofanytreatmentstoremoveparticlesfromimplantsurfaces
identityofagentsusedinparticleremoval
chemicalanalysisofthesurfacetoverifythatanychemicalsusedtoremove
particleshavebeenwashedfromthesurface
photomicrographsofblastedsurfacestoshowwhetherornotthereareparticles
remainingbehindonthesurface.
Backtothetop
12.ClinicalStudies
InaccordancewiththeleastburdensomeprovisionsoftheFDAModernizationActof
1997,theagencywillrelyonwelldesignedbenchand/oranimaltestingratherthan
requiringclinicalstudiesfornewdevicesunlessthereisaspecificjustificationfor
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askingforclinicalinformationtosupportadeterminationofsubstantialequivalence.
While,ingeneral,clinicalstudieswillnotbeneededformostimplantorabutment
devices,FDAmayrecommendthatyoucollectclinicaldatafordeviceswithanyone
ofthefollowingcharacteristics:
materialformulationsordesignsdissimilarfrommaterialformulationsordesigns
previouslyclearedunderapremarketnotification
lengthslessthan7mmand/orimplantdiameterslessthan3.25mm
anangulationoftheaccompanyingorrecommendedimplantabutmentgreater
than30
newtechnology,i.e.,technologydifferentfromthatusedinalegallymarketed
implantorabutment
indicationsforusedissimilarfromdevicesofthesametype.
FDAwillalwaysconsideralternativestoclinicaltestingwhentheproposed
alternativesaresupportedbyanadequatescientificrationale.TheDentalDevices
Branchisavailabletodiscussanyquestionsyoumayhave.
Ifaclinicalstudyisneededtodemonstratesubstantialequivalence,i.e.,conducted
priortoobtaining510(k)clearanceofthedevice,thestudymustbeconductedin
accordancewiththeInvestigationalDeviceExemptions(IDE)regulation,21CFRPart
812.FDAbelievesthisdeviceisasignificantriskdeviceasdefinedin21CFR
812.3(m)(4)and,therefore,studiesinvolvingthesedevicesdonotqualifyforthe
abbreviatedIDErequirementsof21CFR812.2(b).Inadditiontotherequirementof
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havinganFDAapprovedIDE,sponsorsofsuchtrialsmustcomplywiththe
regulationsgoverninginstitutionalreviewboards(21CFRPart56)andinformed
consent(21CFRPart50).
Clinicalinvestigationordinarilyshouldincludearandomized,wellcontrolledclinical
trialdesignedtodemonstratethesubstantialequivalenceofthedevicewhenusedas
describedintheIndicationsforUsestatement.Itmaybepossibletousehistorical
controlswhenthehypothesesarethesameandtheprotocolsaresimilar.For
statisticalpurposes,thestudyshoulddemonstratethedeviceissubstantially
equivalentto,ornotinferiortotheperformanceoflegallymarketedpredicatedevices
ofthistype.Eachstudyarmshouldhaveastatisticallyvalidnumberofpatients.We
recommendthatyouconsultastatisticianfamiliarwithmedicaldevicestudies.
FDArecommendsthatyouconductanyclinicalevaluationsofimplantsand
abutmentsforthreeyearswiththeimplantunderloadedconditions.Resultsshould
includesuchinformationasimplantmobility,infections,brokenimplantsorabutments,
adverseevents,andshouldalsoincludeadetailedexplanationforallpatientslostto
followup.Resultsderivedfromtheseinvestigationsshouldmeetthedefinitionofvalid
scientificdataasdefinedin21CFR860.7.Thestudiesshouldbeconductedby
investigatorsexperiencedinimplantdentistry,clinicalresearchdesign,anddata
analysis.
InclusionandExclusionCriteria
Werecommendthatyoudefinetheinclusionandexclusioncriteriainyourclinical
studyprotocol.Werecommendthatyoudescribeandexplainanydeviationsfrom
yourinclusionandexclusioncriteria.Wealsorecommendthatyoudescribethestudy
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populationintermsofthedistributionofthevariables,ifrelevanttostudyoutcome,
listedbelow:
intendeduseofthedevice
numberofpatientsinexperimentalandcontrolgroups
ageandgenderdistributionofthepatientsintheexperimentalandcontrolgroups
statusofdentition(dentatevs.edentulous,minimumnumberofteethand
maxillomandibularjawrelationships)
occlusalscheme(i.e.,crossbites,tiltedteeth,teethinbuccoversion/labioversion)
minimalridgedimensionsandqualityofbone(TypeIIV7),ifpartoftheprotocol
applicableprostheticvariables,suchasrestorativematerials,permissibleabutment
angulation,andlengthofspanforimplantsupportedbridges.
PreimplantationAssessment
Thepreimplantassessmentdescribedinyourstudyprotocolshouldinclude:
descriptionofthegeneralhealthofthepatient,identifyinganymedicalconditions
thatmayaffecttheoutcomeofthestudy
descriptionofthepatientsdentalstatusthatmayaffecttheoutcomeofthestudy
locationoftheintendedsite(s)forimplantation
descriptionofspecialconditionsforwhichtheimplantistobeused(e.g.,TypeIV
bone,formaxillarysinusareas),
descriptionofpathologicalconditions(e.g.,infection,bleeding,inflammation)
conditionoftheopposingteethandtypeofocclusion
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identificationofpatientswhobruxorclench
oralhygieneregimentobeusedaroundtheimplantbasedoninstructionsinthe
labeling
densityofboneattheimplantsite(i.e.,TypeItoTypeIVbone).
Thepreimplantassessmentdescribedinyourstudyprotocolshouldalsoinclude
standardizedradiographstoquantifytheridgeheightandwidthofthesupporting
boneandlocatemajoranatomicalfeatures.Radiographstakenoverthestudyperiod
shouldbereadilycomparable.Youshouldalsousethisprocedureinthepostimplant
assessments.Examplesofappropriateradiographsare:
periapicalorpanoramicradiographs
extraoralradiographs
cephalometricradiographs
ComputedAxialTomography(CAT)scans.
PostimplantAssessment
Thepostimplantassessmentdescribedinyourstudyprotocolshouldincludethe
informationdiscussedbelow.
ClinicalandRadiographicAssessmentFrequency
Werecommendthatyouspecifyhowfrequentlyclinicalandradiographicassessment
willoccur.Postsurgicalintervalsthathavebeenreportedinthedentalliteratureare
generallyacceptable.Examplesoftheseintervalsareweeklyforthefirstmonth,3
months,6months,12months,2years,and3years.Minordeviationsfromthis
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sequenceshouldnotconflictwiththeprotocol.Abbreviatedevaluationintervalsor
significantdeviationsfromtheseparametersshouldbejustifiedonthebasisofwound
healingparameters.
IntervalBetweenImplantationStage
Werecommendthatyouspecifythetimeintervalbetweeneachstageofthe
implantation(i.e.,thetimebetweenimplantplacementanduncoveringforabutment
placementandtimebetweenimplantplacementandocclusalloading).The3year
followupperiodshouldbemeasuredfromthetimetheimplantissubjecttoocclusal
forces.Youshoulddescribetheocclusalloadingparametersandvariations
permissiblewithintheprotocol.
MedicationsDuringtheStudy
Werecommendthatyouidentifyanymedicationsandtheamountstakenduringthe
clinicalstudythatmightaffectstudyoutcomes.Medicationssuchasantibiotics,
analgesics,andtopicalrinsesareexamplesofmedicationsthatyoushouldrecord.
Useofantibiotics,analgesics,andtopicalrinsesshouldbestandardizedasmuchas
possible.
Radiographs
Werecommendthatyouobtainradiographsasdescribedinthestudyprotocol.
Radiographsmaynotberequiredateachpostimplantassessment.Youshould
quantifytheamountofalveolarridgeresorptionbasedonradiographs.Youshould
alsodocumentanyradiographicevidenceofperiapicalradiolucency.
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Thepostimplantassessmentdescribedinyourstudyprotocolshouldalsorecordthe
followingclinicalparametersandobservationsduringeachevaluation,where
appropriate.
GingivalHealth
Werecommendthatyouspecifythegingivalandinflammatoryindicesused.
ToothandImplantMobility
Werecommendthatyouspecifymethodofevaluationandtypeofclassificationused.
PocketProbingDepth
Werecommendthatyouusethesametypeofprobeandprobingtechniqueateach
evaluation.Theclinicianstechniqueshouldbecalibratedwithrespecttoforceused
aswellasprobeangulation.Theuseofstents,whereverpractical,mayimproveintra
aswellasinterexaminerreliability.
ClinicalAttachmentLevel
Werecommendthatyouuseastandardizedtechnique,aswellasexaminer
calibration,forthismeasuringtheclinicalattachmentlevel.
PostoperativeComplications
Werecommendthatyourecordanypostoperativecomplicationsencountered,and
thetimesatwhichtheyoccurred.Theseshouldinclude,butneednotbelimitedtothe
postoperativecomplicationslistedbelow:
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anesthesiaorparesthesia,temporaryorpermanent
mandibularfracture
significantlossofalveolarridgeheight,asspecifiedintheprotocol
oteomyelitis,oralantral,ororalnasalfistula
adjacentteethadverselyaffectedbyimplantplacement
abnormalorprolongedpainafterinsertionasdescribedinprotocol
infectionrelatedtoimplantplacement
failuretomaintainadequateoralhygiene.
Ifitisnecessarytoretrieveanyimplantduringfollowup,werecommendthatyou
followASTMF56197PracticeforRetrievalandAnalysisofImplantedMedical
Devices,andAssociatedTissues.
Adversereactionsandcomplications
Werecommendthatyoudescribeandtabulateeachadversereactionand
complication.Theseshouldincludetheeventslistedbelow:
infection
implantlosspriortoloading
implantbreakage
lossofloadedimplants
pain
alteredsensation
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temporomandibularjointproblems
Werecommendthatyouprovidethenumberofpatientsdiscontinued,therationalefor
discontinuation,andthetimeofdiscontinuation.UnderAdverseEvents,youshould
provideadetailedandcompletefailureanalysisreportforeachdevicefailure.
DataTabulation
Werecommendthatyouprovideatabulationofdatafromallindividualsubjectreport
forms.Youshouldincludecopiesofsubjectreportformsforeachsubjectwhodidnot
completetheinvestigation,ifpossible.Youshouldalsoincludeasummarytable
showingthedurationoffollowupforeachsubjectintheinvestigation.
StatisticalAnalyses
Werecommendthatyouprovidetheresultsofstatisticalanalysesfromtheclinical
investigations.Theseresultsshouldincludestatisticalmethodologyandrationalefor
eachstatisticaltest.Youshouldcitereferencesorsubmitformulasforeach
methodology,aswellasanexplanationofanydeviationsfromthemethodology.
Analysisofstatisticaldatashouldshowtherateofsuccess,failure,andcomplications.
Thetimespecificcumulativefailurerateandcomplicationrateshouldbecalculated
bystatisticalsurvivalanalysis.Youshouldincludealifetableanalysis.
AdditionalClinicalStudyInformation
Werecommendthatyouincludearticlespublishedinpeerreviewedjournals,
containinginformationonthedeviceinthe510(k)relevanttotheclinicalstudy(i.e.,for
thesameindication,orusesoftheimplantinaclinicalstudy).
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Werecommendthatyourclinicalstudyprotocolincludeastatementregardingstudy
progressatthetimeyousubmityour510(k),statingwhetherthestudyiscompleted,
inlongtermfollowup,orenrollingpatients.Youshouldalsoincludeastatement
abouthowclearanceofthe510(k)willchangethestatusofthestudy.
Werecommendthatyouincludeintheclinicalprotocolanymethodsnotpreviously
mentionedthatareusedtoeliminatebiasonthepartofthesubjectsorinvestigators.
Backtothetop
13.Labeling
Thepremarketnotificationshouldincludelabelinginsufficientdetailtosatisfythe
requirementsof21CFR807.87(e).Thefollowingsuggestionsareaimedatassisting
youinpreparinglabelingthatsatisfiestherequirementsof21CFR807.87(e).8
ProfessionalLabeling
Asaprescriptiondevice,rootformendosseousdentalimplantandendosseousdental
implantabutmentdevicesareexemptfromneedingadequatedirectionsforlayuse.
Nevertheless,under21CFR807.87(e),instructionsshouldbeclearandconciseand
delineatethetechnologicalfeaturesofthespecificdeviceandhowthedeviceshould
beusedinpatients.Werecommendthatyouprovideuserswithasurgicalmanual
alongwiththeinstructionsforuse.Professionallabelingshouldcontaindetailed
instructions,particularlyforthosesectionsofthesurgicalorrestorationprocedures
wherethedevicediffersfromotherendosseousdentalimplantsystems.Youshould
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provideallrelevantprecautionsandwarningsintheprofessionallabeling.Ifthereare
anyprecautionsorwarningsthatrelatetounpackagingorsterility,werecommend
thatyourepeatprecautionsorwarningsonthepackagelabels.
SterilizationInstructions
Ifanypartsareprovidednonsterile,i.e.,tobesterilizedbeforeuse,werecommend
thatyouprovidesterilizationinstructions.
PatientLabeling
Ifpatientlabelingisappropriate,werecommendthatyoufollowGuidanceon
MedicalDevicePatientLabelingFinalGuidanceforIndustryandFDA
Reviewers
82.htm),inpreparingpatientlabeling.
Backtothetop
AppendixISuggestedFormatforTestReports
Ifyouchoosetosubmitatraditional510(k)orifyouusetestmethodsnotgiveninthe
standardscitedinthisguidance,youshouldsubmittestreports.Thesetestreports
shouldincludethefollowingelements,oranexplanationfortheiromission:
tothetestmethodorsummaryofyourtestprotocol
methodsforsamplepreparation
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drawingofyourtestsetup
failurereport
identificationofthefailureregionsandajustificationofriskiftheregionfallsinan
areawhichwouldrequiresurgicalremovaloftheimplant
acceptancecriteriaforeachtest,unlessspecificationsareincludedinthe
recognizedstandard.
Ifthetestwasconductedinconformancewitharecognizedstandard,youneednot
describethedetailsofthetestmethod.
Backtothetop
1ASummaryTechnicalDocumentationforDemonstratingConformitytotheEssential
PrinciplesofSafetyandPerformanceofMedicalDevices(STEDdocument)that
containstheinformationwerecommendinthisguidancemaysufficeinplaceofthe
summaryreport.PleaserefertoAnnouncementofaPilotProgramforDevice
Submissions(TheSTEDInitiative)
arketSubmissions/SummaryTechnicalDocumentSTEDPilotProgram/default.htm).
2RefertoIndicationsforUseForm
(http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm36043
1.pdf)(PDFFileSize:1.03MB)fortherecommendedformat.
3
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3IfFDAmakesasubstantialequivalencedeterminationbasedonacceptancecriteria,
thesubjectdeviceshouldbetestedandshowntomeettheseacceptancecriteria
beforebeingintroducedintointerstatecommerce.Ifthefinisheddevicedoesnotmeet
theacceptancecriteriaand,thus,differsfromthedevicedescribedinthecleared
510(k),FDArecommendsthatsubmittersapplythesamecriteriausedtoassess
modificationstolegallymarketeddevices(21CFR807.81(a)(3))todeterminewhether
marketingofthefinisheddevicerequiresclearanceofanew510(k).
4
SeeRequiredElementsforaDeclarationofConformitytoaRecognized
Standard
arketSubmissions/PremarketNotification510k/ucm142706.htm)(Screening
ChecklistforAllPremarketNotification[510(K)]Submissions).
5Ifyourdeviceislabeledsterile,werecommendthatyoufollowtheguidancefor
devicesintendedforcontactwithintactskininUpdated510(k)SterilityReview
GuidanceK901FinalGuidanceforIndustryandFDA
83.htm).
6Afteryourdevicehasbeencleared,ifyoureviseyourlabelingtoidentifyadditional
legallymarketedabutmentsorimplantsascompatible,werecommendthatyou
documenthowyoudeterminedcompatibilityandensuredthatyourtoleranceswill
allowyourdevicetobecompatible.Ifyoucannotestablishimplanttoabutment
compatibilitybasedsolelyondescriptiveinformation,youshoulddocumentthe
performancetestingconductedandtheresultsobtainedthatestablishcompatibilityin
yourdesignhistoryfileasapartoftheQualitySystemsRequirements(21CFR
820.30).
7
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7Misch,CE.ContemporaryImplantDentistry.St.Louis,Missouri:Mosby,1999pp
89118.
8Althoughfinallabelingisnotrequiredfor510(k)clearance,finallabelingmust
complywiththerequirementsof21CFRPart801beforeadeviceisintroducedinto
interstatecommerce.Inaddition,finallabelingforprescriptiondevicesmustcomply
with21CFR801.109.Labelingrecommendationsinthisguidanceareconsistentwith
therequirementsofpart801.
Backtothetop
MoreinSearchforFDAGuidanceDocuments
(/RegulatoryInformation/Guidances/default.htm)
FDAGuidanceDocuments:GeneralandCrossCuttingTopics
(/RegulatoryInformation/Guidances/ucm122044.htm)
AdvisoryCommitteeGuidanceDocuments
ClinicalTrialsGuidanceDocuments
CombinationProductsGuidanceDocuments
ImportandExportGuidanceDocuments
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InternationalConferenceonHarmonisation(ICH)GuidanceDocuments
VeterinaryInternationalConferenceonHarmonization(VICH)GuidanceDocuments
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