Storage:•Catalyst syringe:RoomTemperatureonly•All other components:Roomtemperatureorrefrigeration.Allcomponentsshouldbetightlysealedandstoredinacool,dark,lowhumidityenvironmentwhennotinuse.AnyrefrigeratedcomponentsMUSTbebroughttoroomtemperaturebeforeuse.

1ºC34ºF

30ºC86ºF

RxOnly—productisintendedforusebyalicenseddentalprofessional.ForSafetyDataSheet(SDS)gotowww.parkell.com.

Description: Amalgambond® Plus is a self-cure bonding system for amalgam andcompositeresinrestorations.

Indications for Use:• Toothbondingresinforusewithcompositeresinrestoratives,amalgamalloysandasabondingagentforinlays/onlaysorlaminateswhenusedwithappropriatecompositelutingresins.

•Apulpcappingagentforvitalpulpexposurespriortopermanenttoothrestoration.

Contraindications:NotforuseonorbypersonswhohaveamethacrylateorHEMAsensitivity.Useofprotectiveglovesandano-touchtechniqueisrecommended.

Precautions:•Caution:Donotswallow.Not for internaluse.Wash immediately ifaccidentallyappliedtoskin,eyesorsofttissue.

•Caution:Eugenol inhibits thesettingofAmalgambond.DonotuseAmalgambondonsurfacescontaminatedwitheugenol-basedproductssuchasZOE.

•Caution:Topreventcontaminationofsurfacesbeingbondedusearubberdam.

•Caution:UseofretentivepinsinconjunctionwithAmalgambondisnotnecessary

•Caution:NeverusecavityvarnishontoothsurfacepriortoAmalgambond.

Kit Includes (refills also available separately):•DentinActivator‘A’UniversalGel,5ml(hS394)•AdhesiveAgent‘AA’,8mlLiquid(hS374)•Base‘B’,5mlLiquid(hS372)•Catalyst‘C’,0.7mlLiquid(hS371)•HPAPowder,2g(hS376)•PrecisionApplicators,50pc(hS379)•Accessories

Adverse Reactions:BEFORE TREATMENT,inquiryshouldbemadetodeterminewhetherthepatienthashadprevioushypersensitivityreactionstoanyoftheingredientsinAmalgambond.AmalgambondAdhesiveAgent(AA)andAmalgambondBase containHEMA (2-hydroxy-ethylmethacrylate), a known contactallergen.Asmallpercentageofthepopulationisknowntohaveanallergicresponsetomethacrylateresins.Toreducetheriskofallergicresponse,minimizeexposure to thesematerials.Useofprotectiveglovesandano-touchtechniqueisrecommended.Useinwell-ventilatedroom.

Directions:1.Preparecavityforcomposite,amalgamorinlayrestorationasusual.2.Cleanandlightlydrypreparation.

CAUTION:TopreventAmalgambondPlusfromadheringtometalmatrices,coattheinneraspectofthebandwithathinlayerofwax,cavityvarnish,ormineraloil.Failuretoapplyaseparatingmediumtoametalmatrixbandmayresultrestorationfracturewhenthebandisremovedduetoadhesionofthealloytotheband.

3.Dispense1or2dropsofDENTINACTIVATOR(A)intomixingwell.Applytoexposeddentinfor10seconds.Washthoroughlyanddrywithoil-free,moisture-freeair.DENTINACTIVATORcanalsobeusedtoetchenamelthatsurroundspreparationsIFitisleftonenamelfor30secondsbeforewater-rinsing.

4.BrushathinlayerofADHESIVEAGENT(AA)ontoactivateddentinsurfaces.Blowaway“puddles”withaGENTLEair-streamtoachieveaneven,thinlayerofcoverage.Leaveundisturbedfor30seconds.While it isnotnecessarytoapplyADHESIVEAGENTtoetchedenamelsurfaces,bondstrengthwillnotbeaffectedifsomeoverrunsontotheetchedenamel.

5.For Amalgam restorations,begintriturationNOW,soalloywillbereadytocondenseassoonastheAmalgambondPlusresinmixtureofbase/catalysthasbeenappliedtothetoothsurface.(AlloyMUSTbecondensedwhileAmalgambondmixisstillwet.)

6.Dispense2dropsofBASE(B)and1dropofCATALYST(C)intoaclean,drymixingwell.MixthoroughlywithGENTLESTIRRINGfor3-5seconds,andbrushathin,evenlayerontodentinandenamel.Whenplacingamalgam,begincondensationimmediately,beforetheadhesiveresindries.Forcomposites,allowtheadhesiveresintodryfor60-90secondsbeforeapplyingthecomposite.

Virtually Impossible Situations:Forstronger,super-retentiveamalgambondstoteethwhosepreparationleavelittleornosupport,HPApowderisrecommended.TomakeanHPAmix,dispense3dropsBASE,1dropCATALYST,1scoopHPApowderintomixingwellandGENTLYSTIR.Applyathinlayerofthismixturetothepreparation.CondenseamalgamwhilethisHPAmixtureisstillwet.NEVER USE HPA POWDER WITH COMPOSITE

Directions for An Adhesive Pulp Cap:AnAmalgambondpulpcapisnotanalternativetoendodontictherapy.Atoothsufferingirreversiblepulpitis,oronethathaslimitedrecuperativepower,requiresarootcanal.

However,iftheexposureissmall,withfreshbleeding,Amalgambondcanserveasanexcellentcappingmaterial,particularlyifthepatient is youngso thepulphasstrongrecuperativepowers.

Ifyouintendtobondanamalgamrestorationandhavegoodaccesstotheexposure,placeyourlubricatedmatrixbeforebeginningthecap.Ifitishardtosee,however,bandthetoothafterStep5.

1. ApplytheGreenDentinActivatorfor10secondstoboththeexposureandthepreparation.(Theferricchlorideinthesolutionshouldcontrolthebleeding.)

2. Rinsethetooththoroughly.Thenlightlydryittoeliminatestandingwater.

3. DoNOTapplythe“AA”solutionatthisstage.(This35%aqueoussolutionofHEMAmightirritatetheexposedpulp.)MixAmalgambond-PluswiththeHPApowder(3dropsbase,1dropcatalyst,onescoopHPApowder.)

4.Applytheadhesivetotheexposureandthedentinimmediatelysurroundingit.

5.Allowtheadhesivetopolymerize.Thiswillsealtheexposure.

6.ApplytheAAcomponenttotheentirepreparation.Allowittositundisturbedfor30seconds,thengentlyblowoffanypuddles.

Self-Curing Bonding Agent

INSTRUCTIONS FOR USE

Mfd. in Japan for:

Parkell, Inc.,300 Executive Dr., Edgewood, NY 11717 USA (800) 243-7446 • www.parkell.com A00079revN1221

hS370,S372,S371,S394,S393,S374,S376

1.

2.

Base

Catalyst

CB

3.

4.

7.MixtheAmalgambondusingtheappropriateBase:Catalystratio(withorwithouttheHPApowder.)

8.Brushthemixtureontothepreparation.Ifyou’reusingcomposite,allowtheadhesivetocurethoroughly(60-90seconds)beforebeginningthebuildup.

If you’re using amalgam, begin lightly condensing as soon as the adhesive has been applied to the tooth. Do not apply too much pressure or you may disrupt the pulp cap. Since spherical alloys condense easily at low pressure, they’re probably a better choice for pulp caps.

Helpful Hints:Low-viscositycompositeresins“wet”adhesively-preparedsurfacesbetterthanhigh-viscositycomposites.Ifhigh-viscosityrestorativesarepreferred,applyathinlayerofUNFILLEDORFLOWABLECOMPOSITERESINandcurebeforeapplyingthehigh-viscositycomposite.

For Additions to Old Amalgams:Air-abradesurfaceofoldfillingwith50micronAluminumOxideuntil“frosty”.UseDENTINACTIVATORonadjacentdentin.Applythin,evenlayersofADHESIVEAGENTandAmalgambondPlusresin,andcondensenewalloybeforetheadhesiveresindries.ForevenstrongerbondsuseHPApowderasdirectedinthe‘VirtuallyImpossibleSituations’sectionofthismanual.

For Direct Composites, Composite Inlays or Veneers:PlacecompositerestorativeAFTERAmalgambondPlusadhesiveresinhasdriedcompletely.DonotuseHPApowderwhenplacingcomposites.

For Apicoectomy or Endo-Access Seals:HPA POWDER is NOT recommended. Condense amalgam BEFOREAmalgambondPlusresinhasdried.

Disinfection of Containers: Bottles,capsandreusableaccessoriesshouldbecleanedofdebriswithawater-damppapertowelanddisinfectedwithapapertowelsaturatedwithan EPA-registered low-level (HIV/HBV claim) to intermediate-level(tuberculocidalclaim)hospitaldisinfectant.Afterwards, thechemicalresidueshouldbewipedoffwithawaterdamppapertowelandair-dried.Utilizethesurfacedisinfectingprotocolofthedisinfectantmanufacturer.Consultwww.CDC.govforthemostrecentversionofthe“GuidelinesforInfectionControlinDentalHealth-CareSettings”.

Warranty and Terms of Use:ForfullWarrantyandTermsofUseinformation,pleasegotowww.parkell.com.SafetyDataSheets(SDS)areavailableatwww.parkell.com.Parkell’sQualitySystemiscertifiedtoISO13485.

Explanation of Symbols Used:

•Professionaluseonly

•Followinstructionsforuse

•Temperaturelimit

•Flammable

• Irritant(skinandeye)

•Storeproducttightlysealedawayfromdirectsunlight.

•Use-bydate(expiration)

•Batchcode

•Catalogue/stocknumber

•UniqueDeviceIdentifier

•MedicalDevice

•Packagecontents

•Donotuseifpackageisdamaged

•Singleuseonly

•Manufacturer

•5mlbottle/Liquid

•6mlbottle/Liquid

•8mlbottle/Liquid

•2gmbottle/Powder

•Brushtips

•Mixing/Applicationaccessories

•ActivatorBrush

•Catalyst