510(k) Report

Devices descending from K962576

95 later devices reach Spline X Endosseous Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+2K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+2K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+2K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+3K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+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—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K231566ICX-Implant SystemMedentis Medical GmbH20240—
+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—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K220823Preat AbutmentsPreat Corporation202216
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+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—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+6K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+6K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K212664SherlockOpen Implants, LLC20212—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+7K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—