510(k) Report

Devices descending from K101004

199 later devices reach Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+1K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+3K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+3K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+3K213599SuperLineDentium Co., Ltd.20220—
+3K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+3K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+3K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+3K170392S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201716—
+3K170398S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.201717—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K160786RODO Abutment SystemRodo Medical, Inc.20162—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K160244VARIOuniteThommen Medical AG201615—
+3K150295LOCATOR RTxZest Anchors, Inc.201542—
+3K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K133991ISYAltatec GmbH20142—
+3K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+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—
+4K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K220823Preat AbutmentsPreat Corporation202216
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K180609Rodo SmilekeyRodo Medical, Inc.20180—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—