510(k) Report

Devices descending from K002475

596 later devices reach Replace TPS Coated Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K152787ST Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20162—
+5K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+5K152786A Plus Internal Fixture SystemT-Plus Implant Tech. Co., Ltd.20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153779Abutment for BridgesAltatec GmbH20161—
+5K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K151599iSy Implant SystemAltatec GmbH20150—
+5K150040ImplanovaDental Evolutions, Inc.20150—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+5K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+5K133327Saturno (TM) Overdenture Implant SystemZest Anchors, LLC20140—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K133613Intra-Lock Dental ImplantsIntra-Lock International, Inc.20140—
+5K132992TI Star Implant SystemT-Plus Implant Tech. Co., Ltd.20133—
+5K131701Z5MLB, Z5MLCZ-Systems AG20131—
+5K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+5K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+5K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+5K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+5K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—