510(k) Report

Devices descending from K052070

261 later devices reach Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K220823Preat AbutmentsPreat Corporation202216
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+6K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+6K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+6K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+6K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+6K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+6K180609Rodo SmilekeyRodo Medical, Inc.20180—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+6K170394Kisses MiniAchimhai Medical Corporation20170—
+6K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+6K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+6K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+6K151599iSy Implant SystemAltatec GmbH20150—
+6K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+7K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+7K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+7K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K253341Custom Abutments ASMedentika GmbH20250—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+7K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+7K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K213391High Retention Attachment SystemZest Anchors, LLC20227—
+7K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+7K212664SherlockOpen Implants, LLC20212—
+7K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—