510(k) Report

Devices descending from K962023

349 later devices reach Plastic Protection Healing Caps through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+6K192742Straumann Variobase CInstitut Straumann AG20211—
+6K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+6K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+6K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+6K200355Duranext AbutmentsElegant Dental Corp.20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193335SherlockOpen Implants, LLC20203—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+6K181037DIO CAD/CAM AbutmentDio Corporation20187—
+6K171532TruBase STruabutment, Inc.20187—
+6K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+6K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+6K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+6K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+6K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+6K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+6K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+6K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+6K153521IH Implant SystemSewonmedix, Inc.201610—
+6K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+6K160784CAM Titanium BlanksAltatec GmbH20161—
+6K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+6K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+6K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+6K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+6K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+6K113606NNC Gold Abutment for BridgesStraumann USA20120—
+7K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+7K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+7K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+7K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+7K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+7K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+7K243009Mist ICImagine Milling Technologies, LLC20251—
+7K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+7K243824Preat AbutmentsPreat Corporation20250—
+7K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+7K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+7K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+7K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+7K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+7K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+7K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+7K222707IH Implant SystemSewonmedix, Inc.20231—
+7K223663SIMDA AbutmentSimda Co., Ltd.20232—
+7K222636ET Abutment SystemHiossen, Inc.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+7K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+7K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+7K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+7K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+7K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+7K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+7K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+7K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+7K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+7K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+7K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+7K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+7K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+8K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+8K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240977DenQ Sub SLA Implant SystemDenq20240—
+8K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+8K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+8K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+8K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+8K232271SIMDA abutmentSimda Co., Ltd.20230—