510(k) Report

Devices descending from K080239

164 later devices reach P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+1K130618Sfi-AnchorCendres & Metaux SA20142—
+1K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+2K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+2K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+2K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+2K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+2K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+2K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+2K142407Straight Stud AttachmentSterngold Dental, LLC20141—
+2K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+2K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+2K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+2K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+3K191123Multi-unit AbutmentsMedentika GmbH202011—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+3K162390ET Hybrid AbutmentHiossen, Inc.20172—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+3K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+3K150250SternSnap Angled AttachmentSterngold Dental, LLC20150—
+3K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+3K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K233389EK Digital AbutmentsHiossen, Inc.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K170421ET Hybrid AbutmentHiossen, Inc.20180—
+4K171795Thommen Implant SystemThommen Medical AG20170—
+4K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+4K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+4K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+5K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220823Preat AbutmentsPreat Corporation202216
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K192742Straumann Variobase CInstitut Straumann AG20211—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—