510(k) Report

Devices descending from K101945

180 later devices reach Neodent Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K220823Preat AbutmentsPreat Corporation202216
+4K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+4K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193335SherlockOpen Implants, LLC20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+4K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K243278Custom AbutmentsInstitut Straumann AG202501
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+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—
+5K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+6K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K243732Multi-Unit DAS SystemTalladium España, SL20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K243530Dynamic TiBaseTalladium España, SL20250—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—