510(k) Report

Devices descending from K980549

601 later devices reach Osseotite Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K233137Ticare Dental Implant SystemsMozograu S.A.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+4K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220823Preat AbutmentsPreat Corporation202216
+4K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+4K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K202825BTI Extra-Short Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20210—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K181037DIO CAD/CAM AbutmentDio Corporation20187—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K173257BTI Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20180—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180609Rodo SmilekeyRodo Medical, Inc.20180—
+4K172240SPI Dental Implant SystemMsi France20180—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+4K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+4K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+4K131701Z5MLB, Z5MLCZ-Systems AG20131—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+4K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+4K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—