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AB DENTAL SUMMARYAPR 18 2012CompanyAB Dental Devices Ltd.3 Habosemn St, AshdodIsraelTelephone: ( 972) 8-853-1 388Fax: ( 972) 8-8522262FDA Establishment Registration # 3005663340ContactDr. Charles HurwitzRegulatory ConsultantMedicSense LtdROB 367Ramat Hasharon 47103IsraelPhone: 972 3 9233666Fax: 972 39231274Email: charles@medicsense.comClassificationNamePer 21 CFR 872.3640* Endosseous Dental Implants and Accessories Product CodeDZE" Abutment, Implant, Dental Endosseous. Product Code NHADevice DescriptionAB Dental implants are designed to support prosthetic devices inedentulous or partially edentulous patients to restore esthetics andchewing functions.2
The purpose of this submission is to add new implants, abutmentsand other items and to receive approval for a new surfacetreatment to previously-approved implants.Indications for UseThe AB Dental Devices implants are intended for surgicalplacement in the maxillary and/or mandibular arch to supportcrowns, bridges, or overdentures in edentulous or partiallyedentulous patients.17 Integral implant, 15 Conical implant, P15 Temporary abutment,P12-T,L Temporary flat connection abutment, and P16 Straightadaptor are appropriate for immediate loading when good primarystability is achieved and with appropriate occlusal loading.3
Identification of the Legally Marketed Predicate Devices Used toClaim Substantial EquivalenceThe following predicate devices are cited:AB Dental ProductPredicate and K numberPredicate and K number12 Screw TypeAB Dental 12, screw type,15 ConicalAB Dental, 15 Conical, K05171917 IntegralAS Dental, 17 One-piece,MIS Implant Technologies, BieCr,1000M.I.S Implant Technologies,Lance, K(040807M.IS Implant Technologies, UnoK(051719one piece screw type, K080162Nobel Biocare, Nobel Active,K(102436AS Dental, P1-Non HexedAbutment, K(051719ADIN, Touareg WP5inmD,K(081751Biohorizon, Titanium TemporaryAbutments - Non-hexed,K103691Biohorizon, Internal Laser-LakK051719110 TrapezeP1-Non Hexed AbutmentAS Dental, P3 Abutment Anti-P3 Abutment Anti-rotationAS Dental, P3 Narrow AbutmentAnti-rotation, K(051719P3N-Narrow Anti-rotationAbutmentP3W-MIS, MD-WMAC1 WideWide anti-rotationcementing post, SP,abutmentP3W--P9HG-3.75,11 Gold ComposedHex AbutmentP12-3.75-K040807MIS, MD-WMAC1 WideWide at Connectioncementing post, SP,K(040807AlfaBio tec, TLABG, 1K063364AlfaBia, tec, TLAW, K(063364MIS, MG-GPC10 Direct goldplastic cylinder with hex. Internalhex, K(063364Adin, FC-6013,6018, K(081751AbutmentP12-3.75-TK(103691MIS, MN-MACtO, Narrowplatform cementing post, NP,K(040807AlfaBia, tec, TLAW, K(063364-Temporary FlatConnection AbutmentAdin, FC-6013,6018, 1(081751Alpha-Bio Tec, Straight TitaniumAbutments ETLA, 1(063364Alpha Bio, HCT, K(042654P15-3x - Temporary Abutmentfor Immediate LoadingPO-P6H for Aesthetic Abutment-with HexP0-Titanium Healing CapAlpha Bio, HS, K(042654Adin, WP0046,0047,0048,0049,0050,P16-Straight adaptorMIS, Pifier Multi Unit, K(040807K0154
ICurrentPredicatePredicateK051 719K040807ProductK NumberPlacement Dual-stepMethodsurgery. LaterexposureDual-step surgery.Da-tpsreyLtrLater dIndicationfor UseFor use in dense For use indenseboneboneLength(s)8,10,11.5,13,16, ,4.5 urfaceFor use indense boneNoSeffeNoTitanium alloyTi-6A1-4V-ELI.Grade-S.Sandblasted andacid etchedsurface .(HA)5,6Titanium alloy Ti6A1-4V-ELI.Grade-s.Sandblasted andacid etchedsurface (SLA).eTitanium alloy. Grade-4.Sadlseanacdthdsuacdled andaiecesrae(L)eTappingProductK NumberPlacement Dual-stepMethodIndicationfor UseIK040807K051719surgery. LaterexposureDual-step surgeryLater exposurerequired.required.Used insoftbone anddesigned toenable thechange ofdirection duringulspsreyexua-posureryaed.epsr eurdUsed insoft boneand designed toenable the change Used insoft boneof direction ,10,11.5,13,16 18,10,11.5,13,1613,3.2,3.75,4.2,4. 13.2,3.75,4.2,4.5,5,5110,11.5,13,1613.75,4.2,5ae
65.mmEdiametersIntegrated]NAbutmentTitanium alloyTI-6Al-4V-ELI.oNTitaniumalloy Ti-6A1-4V-ELI.ExndaoForimdateFor imedateFor immendlate ladaig.cheIntegeYesYesYesMaterialPlatement Sangl-step n Sandla-stedpnSufcMdetchsredacisretchedoesure HAosure reuiA).TapinPullmoterYesSandleasted anderyacisuiredL.GADentalExerSal nd la teehYesngoaiq10,.5,1 1stentateh n u al y(Newtons-ELITitanium alloy. Grade-4.335Tta i m -lo6AI-4V-EL.Grade-Nobe loarnd Sa d la teTt n um al y T - A - V E IAIadSa db a te a d cd t6eue
MethodIndicationfor UseIsurgery. Nosurgery. NSoSnl-tpsreyexpoureexposure required.required.Is suitable for allindications andoffersexceptionalprimary stability.Designed toenable thechange ofdirection duringIssuitable for allindications andoffers exceptionalprimary stability.I utbefralidctosI 3,163.7514.2, 54.3,55IntegratedNoNoAbutmentMaterialNoTitanium alloyTi-6A1-4V-ELI.Grade-S.ExternalSurfaceTitanium alloy Ti-6A1-4V-ELI.TitaniumAnodized surface:Sandblasted and partial crystallineacid etchedand phosphateenriched inBFornpermanentand fintnal7OsseoFix, Calcium phosphatetreated surface.Oxide surface.permanentYero.Indicationoepsrtwo 0dy)
and finalrestoration.Dimension Diameter:3.75Length:9,13sTitanium alloyMaterialTi-6A1-4V-ELI.Grade-5.NoAnleAB Denalrequired, forback teeth.When space islimited, betweentwo teeth orimplants at theanterior of themouth. For thickgums when theimplant isverydeepDimension Diameter3,3.75,5sLength:5,7,9,12,15Titanium 7 Length:1 2Diameter:3.75Length:9,13Titanium alloy Ti6A1-4V-ELI.Grade-5.NoTitanium alloyAS3 DentalBlohorizanare required, forback teeth. Whenspace is limited,between two teethor implants at theanterior of themouth. For thickgums when theimplant is verydeep.NoDesigned to be placed at implantsurgery or uncover and remain inplace through final restoration.Djirneter:3.5,4.5,5.7Leflgth: 4 ,S.5Diameter:3.75Length:5,7,9,12,lSTitanium alloy Ti6A1-4V-ELI.Grade-5.Titanium Alloy.Detr:l7 CufDaer:3545Titnutiaollo87AlloccoTu itaniuCf
Indicationfor UseTo be usedwhen space islimited, betweentwo teeth orimplants, usuallyat the anterior ofthe mouth.Dimension Diameter:3.75sLength:5,7,9.MfaterialTtnium alloyTi-GAI-4V-ELI.To be used whenspace is limited,ob sd hn pceibetween two teeth lmto betedwenspatetisor implants,imilated, between t teet atrirousually at theimplants, usually at the anterioroanterior of thetemuhmouth.Diameter:3.75-Diameter:3.75 Lengt: 1Length:5,7,9.Titanium alloy Ti6A1-4V-ELI.Titanium alloyAB DenalMISAifaffloNameK Number K06336K040807Indicationfor UseTo be-usedwhen there is awide spacebetween twoteeth orimplants, usuallyat the posteriorpart of themouthDbimension Diameter: 3.75sLength: 9, 12.MaterialTitanium alloyTi-GAI-4V-ELI.Grade-5.Annle0ABtacnta-lTo be used whenthere isa widespace betweentwo teeth orimplants, usuallyat the posteriorpart of the mouthTo be used when there is a widespace between two teeth orimplants, usually at the posteriorpant of the mouth-Diameter:5.5Diameter: 4.5Length:1 11Length:9TitaniumTitanium00Adin9
V-ELI.NoNoAS DentalADNo-DentalMIS
ProductName-INumberIndication Abutment with a K081 751for Useflat connectionAbutment With afor screwflat connection forretainedscrew retainedrestoration onrestoratio ontiltedImlantstilted implantsDimension Diametet:4.5Daee5Len th:sLiaen ItsMaterialTitanium alloyTitniu aloyTiTi-6A1.4v-ELI.6 Al-4v.sLl.Anlerade-sGrade-5sfor Useabuhent with aflat connectionfor Screwretainedrestoration ontilted im lantsDimension Diameter:.sS Lenth:1Abutment with aflat connection forsre retainedrsoainotfltiplntsnPatDaee:iamte10
for sion Diameter:3, 3.75 Daee:.,.sLength: 1,2,3,4,5 Diaente:3.94.Legh7MaterialTitanium alloyTitanium alloy TiTi-GAI-4V-ELI.6Ai-4V-ELI.I plastic.Grade-5 plastic.P5roductNameR42ANumberIndication Used to allow thefor Usegingiva to healaround P6HabutmentDimensio Diameter:4.7nsLength:5Material Titanium alloy ionfor UseP0-TitaniumHealing CapK042654Used to allow thegingiva to healaround P6HabutmentAlpha BlodInHSWP-0046,0047,0048,0049,0050K042654Used to allow thegingiva to healamound implantsimtr45Daer:Length:2,3,4,5,6,7K081 751Used to allow the gingiva to healarudipntarudipntUsed to allow thegingiva to healaround implantsDimenslo Diameter:3.756,7egh:,,45Material Titanium alloy Ti6AI-4V-ELI.TitaniumGrade-5ADAPTORSAD DentalDiameter:4.7Length:5Titanium alloy Ti6A1-4V-ELI.Grade-5MISLength:2,3,4,5,6Titanium alloy Ti-6A1-4V-ELI.Grade-5
NameNubeIndication Used for screwfor UseretainedK040807Used fortemporaryrestorationrestorationDimenslo Diameter:3.O,3.75 Diameter:3.75nsLength: 1,2,3,4,5. Length:1 .2,3,4Material Titanium alloy Ti- Titanium alloy TiBAI-4V-ELI.6A1-4V-ELI.Grade-SBrief Discussionof the Non-Clinical Tests SubmittedAs part of demonstrating safety and effectiveness of AB Dental dental implantsand inshowing substantial equivalence to the predicate devices that are thesubject of this 51 0(k) submission, AB Dental submitted a selected number of itsdental implants for fatigue testing inaccordance with ISO 14801, Dentistry Implants - Dynamic Fatigue Test for Endosseous Dental Implants.Further, AB Dental dental implants also underwent extensive SEM surfaceanalysis and surface topography studies to prove that the blasting and postblasting surface cleaning process used during the manufacture of these devicesproduced implants that resulted ina clean, textured, surface.In addition, the 17 implants were subjected to pullout testing.Clinical TestingNo clinical testing was performed. Non-clinical testing was used to support thedecision of safety and effectiveness.ConclusionsWe believe that the AB Dental Implants products, which are the subject of thissubmission are substantially equivalent predicate devices cited. The deviceconstitutes a safe, reliable and effective medical device, meeting all declaredrequirements of its intended use and the device does not introduce new risks anddoes not present any adverse health effects or safety risks to patients when usedas intended.12
DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health ServiceFood and Drug Administration10903 New Hampshire AvenueDocument Control Room -W066-G609Silver Spring, MD 20993-0002A.B. Dental Devices, LTDC/O Charles Hurwitz, Ph.D.MedicSense LTDPOB 367Ramat HasharonISRAEL 47103APE 18 2012Re: K 112440Trade/Device Name: AB Dental Devices Implants and AccessoriesRegulation Number: 21 CFR 872.3640Regulation Name: Endosseous Dental ImplantRegulatory Class: 11Product Code: DZE, NHADated: April 10, 2012Received: April 13, 2012Dear Dr. Hurwitz:We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for theindications for use stated in the enclosure) to legally marketed predicate devices marketed ininterstate commerce prior to May 28, 1976, the enactment date of the Medical DeviceAmendments, or to devices that have been reclassified in accordance with the provisions ofthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarketapproval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. 'The general controls provisions of the Act includerequirements for annual registration, listing of devices, good manufacturing practice,labeling, and prohibitions against misbranding and adulteration. Please note: CDRI- doesnot evaluate information related to contract liability warranties. We remind you, however,that device labeling must be truthful and not misleading.If your device is classified (see above) into either class 11 (Special Controls) or class Ill(PMA), it may be subject to additional controls. Existing major regulations affecting yourdevice cah be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. Inaddition, FDA may publish further announcements concerning your device in the FederalRegister.
*Page 2 - Dr. HurwitzPlease be advised that FDA's issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requirementsof the Act or any Federal statutes and regulations administered by other Federal agencies.You must comply with all the Act's requirements, including, but not limited to: registrationand listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting(reporting of medical device-related adverse events) (21 CFR 803); good manufacturingpractice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);and if applicable, the electronic product radiation control provisions (Sections 531-542 of*the Act); 21 CFR 1000- 1050.If you desire specific advice for your device on our labeling regulation (21 CFR Part 801),please go to RHOffices*/ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office ofCompliance. Also, please note the regu lation entitled, "Misbranding by reference topremarket notification" (21 CFR Part 807.97). For questions regarding the reporting ofadverse events under the MDR regulation (21 CFR Part 803), please go aProblem/default.htm for the CDRH'sOffice of Surveillance and Biometrics/Division of Postmarket Surveillance.You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at itstoll-freenumber (800) 638-2041 or (301) 79677100 or at its Internet sforYouIndustry/default.htm.Sincerely yours,.Anthony D. Watson, B.S., M.S., M.B.A.DirectorDivision of Anesthesiology, General Hospital,Ifection Control and Dental DevicesOffice of Device EvaluationCenter for Devices andRadiological HealthEnclosure
Indications far Use510 (k) Number K1 12440Device Name: AB Dental Dental Devices Implants and AccessoriesIndications For UseS The AB Dental Devices implants are intended for surgical' placement in the maxillaryand/ormandibular arch to support crowns, bridges, or overdlentures in edlentulous or partiallyedentulous patients.17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporaryflatconnection abutment, and P16 Straight adaptor are appropriate for immediateloading whengood primary stability is achieved and with appropriate occlusal loading.Prescription Use XAND/OR(Part 21 CFR 801 Subpart D)Over-The-Counter Use(21CFR 807 Subpart C)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGEIF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE(Page 1 of 1(Division Sign-off)Division of Anesthesiology, General HospitalInfection Control, Dental Devices510Ok) NumberK I Lf
AB Dental implants are designed to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing functions. 2. The purpose of this submission is to add new implants, abutments and other items and to receive approval for a new surface treatment to previously-approved implants. .
