510(k) Report

Devices descending from K073075

304 later devices reach Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180282MIS Internal Hex Dental Implant SystemMis Implants Technologies, Ltd.201811—
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K131066Axiom RegAnthogyr Sas20142—
+1K122268Angled Xive MP Abutment, Angled AnkylosDentsply International20122—
+1K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+1K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+1K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc.2009290—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+2K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K200102MIS Dental Implant SystemDentsply Sirona20200—
+2K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K192149MIS Dental Implant SystemDentsply Sirona, Inc.20191—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K173701Implant-One SystemImplant Logistics, Inc.20181—
+2K161177Axiom PXAnthogyr Sas20170—
+2K151757IMMEDIATELOAD Dental Implant SystemImmediateload S.A.20160—
+2K151588maxFit II Dental Implant SystemTaiwan Implant Technology Company, Ltd.20160—
+2K141188Microdent Genius Implant SystemImplant Microdent20150—
+2K141450AXIOM 2.8Anthogyr Sas201401
+2K140347Ankylos C/X Implant SystemDentsply Intl., Inc.20146—
+2K131644Ankylos Syncone Abutment 5(Degree)Dentsply International, Inc.20141—
+2K120414Osseospeed PlusAstra Tech AB2012196—
+2K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+2K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+3K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+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—
+3K220823Preat AbutmentsPreat Corporation202216
+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—
+3K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+3K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc.20194—
+3K182908Ziacom Dental Implant SystemsZiacom Medical, S.L.20190—
+3K183079Conometric AbutmentsDentsply Sirona, Inc.20190—
+3K180924Reflect Implant SystemIds - Integrated Dental Systems20190—
+3K172821Ti-one 101 TS Dental Implant SystemHung Chun Bio-S Co., Ltd.20180—
+3K172505MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical…Mis Implants Technologies, Ltd.20174—
+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—
+3K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+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—