510(k) Report

Devices descending from K945847

570 later devices reach Frialit (R)-2 Stepped Screw with Deep Profile Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+5K110337Universal Maxillary MolarOco Biomedical20121—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K113606NNC Gold Abutment for BridgesStraumann USA20120—
+5K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+5K103234GC Aadva BO AC AbutmentsGC America, Inc.20111—
+5K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+5K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+5K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc.2010199—
+5K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+5K081851Neoss Access AbutmentsNeoss, Ltd.20090—
+5K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+6K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K253341Custom Abutments ASMedentika GmbH20250—
+6K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+6K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+6K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K230103Klockner AbutmentsSoadco, S.L.20230—
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+6K213677Bonafix 2 PlusZentek Medical, LLC20220—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222368Mist ICImagine Milling Technologies, LLC20222—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K220823Preat AbutmentsPreat Corporation202216
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+6K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+6K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+6K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210610PrimeTaper EV Dental ImplantDentsply Sirona, Inc.20210—
+6K193352AbutmentCADExocad GmbH20210—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K210220Kontact Dental Implant SystemBiotech Dental, Sas20217—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+6K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+6K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+6K200386Z5-BLZ-Systems AG20200—
+6K200100Abutment Design3Shape A/S20203—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+6K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+6K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+6K193335SherlockOpen Implants, LLC20203—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—