510(k) Report

Devices descending from K041938

271 later devices reach Maximus OS (Overdenture System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+6K182246Mist ICImagine Milling Technologies, LLC20194—
+6K183518Preat AbutmentsPreat Corporation2019223
+6K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+6K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+6K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+6K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+7K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+7K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+7K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+7K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+7K243278Custom AbutmentsInstitut Straumann AG202501
+7K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+7K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+7K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+7K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193335SherlockOpen Implants, LLC20203—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K171795Thommen Implant SystemThommen Medical AG20170—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K221966Dynamic TiBaseTalladium Espana, SL20225—
+9K220482SherlockOpen Implants, LLC20221—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+10K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+10K231559Multi-Unit DAS SystemTalladium España, SL20231—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+12K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—