510(k) Report

Devices descending from K150203

129 later devices reach Medentika CAD/CAM Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+1K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+1K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+1K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+1K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+1K200355Duranext AbutmentsElegant Dental Corp.20200—
+1K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+1K181037DIO CAD/CAM AbutmentDio Corporation20187—
+1K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+1K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+1K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+1K160784CAM Titanium BlanksAltatec GmbH20161—
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+2K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+2K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+2K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+2K223663SIMDA AbutmentSimda Co., Ltd.20232—
+2K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+2K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+2K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+2K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+2K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K242703LW Pre-milled AbutmentOssvis Co., Ltd.20240—
+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—
+3K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+3K232271SIMDA abutmentSimda Co., Ltd.20230—
+3K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+3K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+3K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K220823Preat AbutmentsPreat Corporation202216
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+3K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K212664SherlockOpen Implants, LLC20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—