510(k) Report

Devices descending from K013227

305 later devices reach Screw Vent Implant; Tapered Screw Vent Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K131701Z5MLB, Z5MLCZ-Systems AG20131—
+3K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+3K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+3K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+3K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+3K130221Hero II Dental Implant System, UI Dental Implant SystemMedimecca Co., Ltd.20130—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+3K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+3K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas201131
+3K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K090234Spectra System Dental Implants 2008Implant Direct, LLC20092211
+3K081226Simpact Implant SystemSimpact, LLC20081—
+3K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+3K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K250476NizPlant Dental Implant SystemParagon Implant Mfg., LLC20250—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+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—
+4K213677Bonafix 2 PlusZentek Medical, LLC20220—
+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—
+4K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+4K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+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—
+4K200386Z5-BLZ-Systems AG20200—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192221Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2…Implant Direct Sybron Manufacturing, LLC202032
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+4K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+4K161177Axiom PXAnthogyr Sas20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+4K153509GPS Angled AbutmentImplant Direct Sybron Manufacturing, LLC20160—
+4K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+4K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+4K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+4K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+4K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+4K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+4K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+4K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+4K131066Axiom RegAnthogyr Sas20142—
+4K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+4K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+4K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—